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Licensing and assessment manual

ARPANSA-REG-LA-MAN-240W

Version 3.1

January 2019

Introduction......................................................................................................................................................

Applications for a licence, licence amendment, or exemption from a licence.................................................

Other applications relating to a licence............................................................................................................

Transport applications......................................................................................................................................

Other assessments or reviews..........................................................................................................................

Legislation........................................................................................................................................................

Overview of the application/request process..................................................................................................

1. Licence application or amendment........................................................................................................1.1. Receiving the application.............................................................................................................

1.2. Assessing the application.............................................................................................................

1.3. Documenting the assessment......................................................................................................

1.4. Preparing the licence.................................................................................................................

1.5. Review & approval.....................................................................................................................

1.6. Issue the licence.........................................................................................................................

1.7. Record keeping..........................................................................................................................

1.8. Post-assessment survey.............................................................................................................

1.9. Current licensing basis...............................................................................................................

1.10. CEO’s statement of reasons.......................................................................................................

2. Requests for approval..........................................................................................................................2.1.1 Receiving the application...........................................................................................................

2.1.2 Assessing the application...........................................................................................................

2.2 Documenting the assessment....................................................................................................

2.3 Review & approval.....................................................................................................................

2.4 Record keeping..........................................................................................................................

2.5 Post-assessment survey.............................................................................................................

3. Disposals & transfers............................................................................................................................3.1 Receiving the application...........................................................................................................

3.2 Assessing the application...........................................................................................................

3.3 Approval....................................................................................................................................

3.4 Notification................................................................................................................................

4. Extension of source working life...........................................................................................................4.1 Receiving the application...........................................................................................................



4.4 Approval....................................................................................................................................

4.5 Record keeping..........................................................................................................................

Licensing and Assessment Manual v.3.1 ARPANSA-REG-LA-MAN-240W 2 of

5. Exemptions...........................................................................................................................................5.1 Receiving the application...........................................................................................................



5.4 Review & Approval.....................................................................................................................

5.5 Notification................................................................................................................................

5.6 Record keeping..........................................................................................................................

5.7 Revocation of exemption...........................................................................................................

6. Surrender a licence...............................................................................................................................6.1 Receipt of application................................................................................................................

6.2 Application assessment..............................................................................................................


6.4 Review & approval.....................................................................................................................

6.5 Notification................................................................................................................................

6.6 Record keeping..........................................................................................................................

7. Transport approvals.............................................................................................................................7.1 Receipt of application................................................................................................................

7.2 Application assessment..............................................................................................................


7.4 Approval....................................................................................................................................

7.5 Final notification........................................................................................................................

7.6 Record keeping..........................................................................................................................

8. Periodic licence review.........................................................................................................................8.1 Review.......................................................................................................................................

8.2 Documenting the review............................................................................................................

8.3 Approval....................................................................................................................................

8.4 Record keeping..........................................................................................................................

8.5 Further Regulatory Action..........................................................................................................

Terms and definitions.....................................................................................................................................

Reference.......................................................................................................................................................


Introduction

This manual covers the assessment and approval of applications from stakeholders and the continuous improvement of those processes. The following applications are addressed:

Applications for a licence, licence amendment, or exemption from a licence

Source licence

Facility licence - Prescribed Radiation Facility / Nuclear Installation

o Site

o Construct

o Operate

o Possess or control

o Decommission

Request for an exemption.

Other applications relating to a licence

Request for consent to surrender a licence

Request for approval to make a relevant change

Request for approval to construct an item important for safety

Request for approval to load nuclear fuel

Request for approval to transfer or dispose of controlled apparatus or controlled material

Request to use a sealed source beyond its recommended working life.

Transport applications

Request for approval to transfer a security enhanced source

Request for approval of shipment (transport) of radioactive material

Request for approval of a shipment under special arrangement

Request for Approval of Special Form Radioactive Material & Low Dispersible Radioactive Material

Request for approval of a package design

Request for approval for validation of a package.

Other assessments or reviews

Periodic licence review

Licence merger process.


Legislation

Australian Radiation Protection and Nuclear Safety Act 1998 (the Act)

Australian Radiation Protection and Nuclear Safety Regulations 2018 (the Regulations).


Overview of the application/request process


1. Licence application or amendment1

1.1. Receiving the application

All applications should be received via the Licence Administration (LA) shared mailbox. If an officer receives a direct request it should be forwarded to LA.

The Safety Systems Support Officer (SSSO) saves the application in the records management system (RMS) and enters details into the Licence Administration Database (LAD).

For licence applications or amendments, the SSSO conducts an initial check to determine whether all sections of the application have been completed and the following information provided:

details of person submitting the application

applicant’s authorisation

nominee details (if applicable)

contact person’s details

Radiation Safety Officer (RSO) details

description of conduct or dealing

For applications or amendments associated with a specific licence or licence holder, the SSSO assigns it to the lead inspector. For new applications, the Director of Facility Safety or Director Source Safety and Security will assign it to an appropriate regulatory officer (RO).

The SSSO acknowledges receipt of the application via email with a copy to the lead inspector/RO.

If the application is complete the SSSO will ask Finance to issue a debtor invoice via the record management system (HPRM).

1.1.1. Public notice (section 48 of the Regulations)

As soon as practicable after receiving an application for a facility licence the CEO must publish a notice in a daily national newspaper and on the ARPANSA website stating that the CEO intends to make a decision on the application.

The RO must complete a Notice of intention to make a decision on a facility licence application with the preferred publication date. This is reviewed by the Chief Regulatory Officer and sent to the SSSO who will arrange for it to be published in the newspaper and on the website. A copy of the notice must be saved in HPRM as proof of compliance with section 40 of the Regulations.

1Under s36 of the Act, the CEO may at any time amend a licence. For example, a licence may be amended to: impose additional licence conditions, remove or vary conditions already imposed, or extend or reduce the authority granted by the licence.

A decision to amend a licence may be at the request of the licence holder or may be taken by ARPANSA as, for example, enforcement action (refer to REG-COM-MAN-270W Compliance and Enforcement Manual).

An application for amendment of an existing source licence is submitted using one of the source licence application forms. Applications for amendment of a facility licence are less common and generally take the form of a written request. The assessment of an amendment generally follows a similar process to that for a licence application. Changes with significant implications in facilities are managed through section 63 of the Regulations and may not necessarily result in a licence amendment.


1.2. Assessing the application

Note: The RO must confirm receipt of the application fee with the SSSO or Finance before starting the assessment.

1.2.1. Agreed assessment time

The RO should agree a timeframe for completion of the assessment with the applicant. This should be done by email and must be recorded in ARPANSA’s intranet site. The level of assessment hence the time taken should be commensurate with the hazard of the source or facility taking into account the adequacy of information in the application; for example, the assessment of an application for a low hazard source should not take more than two working days, however the assessment of a complex facility application may take in the order of 60–90 days. No agreement is required if the assessment is expected to take five working days or less.

1.2.2. Assessment criteria

The RO assesses the application against safety standards relevant to the controlled facility, controlled material or controlled apparatus. The regulatory assessment report (RAR) template will guide the RO through the assessment process and the matters that must be taken into account and recorded.

Relevant codes and standards are available at https://www.arpansa.gov.au/regulation-and-licensing/regulatory-publications/radiation-protection-series/codes-and-standards .

Links to international best practice can be found at https://www.arpansa.gov.au/regulation-and-licensing/regulation/international-best-practice .

For assessment of applications for an accelerator or irradiator checklist may assist.

1.2.3. Further information & site visits

Where required, the RO will request further information via email. Note that the legal power to request additional information comes from paragraphs 46(2)(b)and 47(2)(b) of the Regulations.

Additional information may also be obtained by the RO undertaking one or more meetings or site visits. Site visits allow face to face clarification of issues as well as to acquaint the RO with the source or facility for which the authorisation is sought. Details of site visits should be recorded using the site visit report template and must also be recorded in LAD.

This process continues until the RO is satisfied that the information provided is sufficient to make a recommendation to the CEO or delegate. The level of detail should be commensurate with the nature of the hazards and risks associated with the proposed conduct or dealing. Facilities that are inherently more hazardous and have the potential to pose a greater risk require more detailed information.

A graded approach should also be applied to expectations around the provision of additional information. A reasonable timeframe for providing information relating to low or medium sources is 1–2 weeks; for high hazard sources and basic PRFs a reasonable time is 2–3 weeks; and for complex facilities it may take 4–6 weeks or more depending on the nature of information requested. The timeframe for provision of additional information may be renegotiated as necessary and records updated.

If there is no response to the request for further information after six weeks, the RO should confirm whether the licence holder wishes to proceed with the application. If there is still no response after two months, the application may be considered withdrawn and the applicant advised accordingly.


https://www.arpansa.gov.au/regulation-and-licensing/regulation/international-best-practice

https://www.arpansa.gov.au/regulation-and-licensing/regulation/international-best-practice

https://www.arpansa.gov.au/regulation-and-licensing/regulatory-publications/radiation-protection-series/codes-and-standards

https://www.arpansa.gov.au/regulation-and-licensing/regulatory-publications/radiation-protection-series/codes-and-standards

1.2.4. Expert advice

Where appropriate, the RO should discuss with their director/branch head the need to seek expert advice on any specialised aspects of the application from other parts of ARPANSA or external consultants. In such cases, the terms of reference and deadlines should be clearly stated.

For applications involving medical sources or facilities, the RO should liaise with Medical Radiation Services Branch to determine whether there are any special considerations with regard to medical exposure and patient protection. Similarly, if there is a need for expert advice on radioactive waste or environment protection issues, the RO should liaise with Radiation Health Services Branch.

1.2.5. Endorsement of security plan

The security plan for a nuclear installation, prescribed radiation facility or security enhanced source must be endorsed by an accredited assessor. The security plan for a nuclear installation, PRF and security enhanced source cannot be endorsed without a site visit unless it has been previously approved and the new application has no impact on the current security arrangements.

1.2.6. Public consultation

If the licence application is for a nuclear installation, a public consultation process must be undertaken. This requires the RO to liaise with the Office of the CEO to arrange for the required information to be published on the website and to arrange public meetings, media releases, etc.

In accordance with paragraph 53(h) of the Regulations the CEO must take into account the content of any public submissions when making a decision on whether to issue a licence. The RO must ensure that the regulatory assessment report (RAR) includes a comments resolution table in which all comments are addressed.

1.3. Documenting the assessment

The RO records the assessment of the application in a RAR using the appropriate template for facilities, high hazard sources, or low and medium hazard sources.

Each RAR must:

cover all matters that the CEO is required to take into account in making a decision on the issue of a licence as per subsections 32(3) or 33(3) of the Act and sections 53 or 54 of the Regulations

include a comments resolution table if public consultation has been conducted

contain a recommendation on whether a licence should be issued

contain justification for recommending any licence condition in addition to those in the licence template or amending or deleting any condition in the licence template

be peer reviewed (usually by the section director)

be independently reviewed where ARPANSA is the applicant

be saved in HPE Records Manager (HPRM).

1.4. Preparing the licence

If a licence or an amendment to a licence is recommended, the licence/amended licence and accompanying letter to the applicant is prepared by the RO.


All details on the licence especially the licence holder’s name must match the LAD exactly.

Where the type of dealing in the application does not match an existing item in Schedule 1 of the licence template, consult the section director and branch quality officer to determine whether an additional item should be created.

A licence is subject to all relevant conditions in the Act and the Regulations. Other standard conditions are listed in Schedule 2 of the licence template. Any additional special licence conditions are based on circumstances specific to a particular application. All special licence conditions require legal review to ensure they are lawful and appropriately worded.

Special licence conditions are not to be used to overcome deficiencies in the application.

1.5. Review & approval

RARs and draft licences undergo the following reviews prior to final sign-off:

[1] Peer review by alternate inspector or other RO

Applications with high risk should be peered reviewed prior to submission to the section head. For other applications, the need for a peer review should be discussed with the section director on a case-by-case basis.

[2] Director review

The directors of Facility Safety and Source Safety and Security are responsible for the quality of RARs. They should check the following:

Correct template is used

Assessment and recommendations are clearly described

Basis for any special licence conditions including those under section 64 or 65 of the Regulations are clearly described.

Directors will determine whether a factual check is required by other expertise in ARPANSA and seek as necessary.

[3] Quality review

After the section director clears the draft, the RO seeks a quality review from the branch quality officer or other designated officer. The reviewing officer will provide advice on the report to the RO and section director. Acceptance of advice is at the discretion of the section director.

[4] Legal review

Legal review is required when the licence deviates from the approved template e.g. where a special licence condition is proposed.

[5] Independent review

Where ARPANSA is the applicant there must be an independent review of the assessment by a state or territory radiation regulator.

A Review & Approval Summary must be completed by the RO to show who has reviewed the documents and when. The summary should be saved in HPRM.


After all reviews are completed, the review summary and links to the RAR, licence, and transmittal letter are sent to the CEO or delegate in an email.

1.6. Issue the licence

When approved, an electronic copy of the signature of the CEO or delegate will be added to the licence and letter. The approval should be recorded in the review and approval summary.

The approved licence and covering letter are converted to pdf, saved over the Word drafts in HPRM, then emailed to the applicant or licence holder with copy to LA.

1.6.1. Calculation of annual licence charge

The CEO may pro-rate the licence charges from the month of licence issue as per section 70 of the Regulations.

Where appropriate, the RO calculates the annual charges using the appropriate form taking into account the month in which the licence is issued.

The RO will advise the SSSO of the licence charges and the SSSO will ask Finance to issue a debtor invoice via HPRM.

1.7. Record keeping

The SSSO will:

Save the notification email in the relevant licence file and ‘alternatively within’ the outgoing correspondence container in HPRM.

Close the application file and raise a licence file in HPRM

Enter relevant information in LAD.

1.8. Post-assessment survey

The lead inspector/RO should arrange for a post-assessment survey to be sent to the applicant if the assessment notification did not include the survey link.

Responses are periodically analysed to identify opportunities for improvement.

1.9. Current licensing basis

The collection of documents that provide the basis on which the licence is issued becomes the current licensing basis (CLB).

The CLB comprises the licence holder's written commitments for operation within applicable regulatory requirements and the facility-specific design basis including all modifications and additions to such commitments over the life of the licence.

For facilities, the CLB will include operational limits and conditions (OLCs), the facility-specific design-basis information documented in the most current safety analysis report (SAR), the licence holder’s plans and arrangements for managing safety, applicable standards and codes and commitments made by the licence holder in the initial application and correspondence to ARPANSA.


A summary of the CLB is maintained for all nuclear installations, complex PRFs, and complex source licences such as the Australian Centre for Neutron Scattering. Changes must be recorded to ensure the basis on which the licence is held remains current.

The summary of the CLB should be saved in the licence holder’s container in the HPRM and ‘alternatively within’ the CLB container in the HPRM.

1.10. CEO’s statement of reasons

The CEO may document the reasons for his decision to issue a licence.

A statement of reasons is prepared and published for all major facilities and any facilities determined by the CEO.

2. Requests for approval

2.1.1 Receiving the application

All requests should be received by LA. If an officer receives a direct request it must be forwarded to LA.

The SSSO will enter the required information into LAD, save the application into HPRM, and assign the application to the lead inspector.

The SSSO acknowledges receipt via email to applicant with a copy to the lead inspector.

2.1.2 Assessing the application

The appropriate RAR template is used to document the assessment; the template will guide the lead inspector through the assessment process.

Assessment of a request to make a change significant for safety under section 63 of the Regulations follows similar processes to that for a new licence – see section 1.

2.1.3 Agreed assessment time

If no further information is required the RO should agree a timeframe for completion of the assessment with the applicant. This should be done by email and must be recorded in ARPANSA’s intranet site. No agreement is required if the assessment is expected to take five working days or less.

2.1.4 Further information & site visits

Where required, the lead inspector requests further information via email. Additional information may also be obtained by the RO undertaking one or more meetings or site visits.

A graded approach should be applied to expectations around the provision of additional information. A reasonable timeframe for providing information relating to low or medium sources is 1–2 weeks; for high hazard sources and basic PRFs a reasonable time is 2–3 weeks; and for complex facilities it may take 4–6 weeks or more depending on the nature of information requested. The timeframe may be negotiated and renegotiated as necessary and records updated.


If there is no response to the request for further information after six weeks, the RO should confirm whether the licence holder wishes to proceed with the application. If there is still no response after two months, the application may be considered withdrawn and the applicant advised accordingly.

2.1.5 Expert advice

Where appropriate, the lead inspector should seek expert advice on any specialised aspects of the application either from other parts of ARPANSA or an external consultant. For applications involving medical sources or facilities, the lead inspector will liaise with Medical Radiation Services Branch to determine whether there are any special considerations with regard to medical exposure and patient protection. Similarly, for advice on radioactive waste or environment protection issues, the lead inspector should liaise with Radiation Health Services Branch.

Where the change impacts an endorsed security plan, re-endorsement of the plan must be obtained.

2.2 Documenting the assessment

The lead inspector will complete (as appropriate):

Email to the Chief Regulatory Officer summarising the request and recommended action

RAR using the appropriate template

Amended facility/source licence

Amended CLB.

If an amendment to a licence is recommended, the processes for preparing and issuing a licence in Section 1 should be followed.

2.3 Review & approval

The review process is the same as for a licence application/amendment in paragraph 1.5 of this manual, noting that legal review is not required for change approvals where the licence does not need to be reissued.

The Chief Regulatory Officer will make a decision in accordance with the powers delegated by the CEO. In some circumstances the CEO may need to be the decision maker.

The inspector will advise the applicant in writing of the outcome of the assessment with relevant documents attached.

2.4 Record keeping

The lead inspector must update LAD, enter agreed timeframe in ARPANSA’s intranet site, and ensure all documents are saved in HPRM.

2.5 Post-assessment survey

The lead inspector should arrange for the post-assessment survey to be sent if the assessment notification did not include the survey link.

Responses are periodically analysed to identify opportunities for improvement.


3. Disposals & transfers

3.1 Receiving the application

All requests should be received by LA. If an officer receives a direct request it should be forwarded to LA.

The SSSO acknowledges receipt of the application via email then refers the application to the assessing officer (AO). The AO may be a RO, or another officer supporting the application.

The AO saves the application in HPRM and records it in LAD.

3.2 Assessing the application

The information required for disposal varies depending on whether it is a controlled apparatus or controlled material. For disposals of a controlled apparatus containing controlled material, the assessment should be based on the controlled material.

The AO will:

check that all the details on the Transfer/Disposal Request Form have been completed

check the details of the described disposal are appropriate as per the Regulatory Guide

confirm with the relevant regulatory authority that any licence number provided belongs to the person/organisation quoted and is relevant for the sources concerned (for transfers)

assess the request to ensure that the pathway is appropriate and there is minimal hazard to persons or the environment relating to the disposal

recommend approval (or otherwise) by forwarding the request via email to an appropriately delegated RO with a brief description of the assessment

save relevant emails in HPRM with any other relevant information and ensure the request and decision are recorded in LAD.

3.2.1 Further information

Where necessary, the AO requests further information. The relevant RO should be contacted if the AO is uncertain about any of the requirements.

3.3 Approval

Only ROs with written delegation from the CEO can approve disposals and transfers. Under section 18 of the Act, the CEO may only delegate powers to persons at senior executive (SES) or executive level (EL1 or EL2).

The delegate will:

check that the assessor has provided an appropriate statement regarding their assessment of the request and taken relevant information into account

make their decision based on the AO’s comments (and licence holder details if necessary)

if not satisfied with the assessment or information provided, send it back to AO giving suggestions for follow up

respond via email to the AO; where approval is granted the words Delegate of the CEO of ARPANSA should be included in the signature block


if the intention is to refuse the request, set out reasons why in an email to the AO.

3.4 Notification

If approved, the AO will notify the licence holder via email that the application has been approved.

If not approved, the AO will notify the licence holder setting out the reasons why and giving them an opportunity to respond within 14 days. Any response will be forwarded to the approver who may reconsider as appropriate.

4. Extension of source working life



The SSSO will save the application in HPRM, record it in LAD and assign it to the lead inspector.

The SSSO acknowledges receipt of the request via email with a copy to the lead inspector.


ARPANSA permits the continued use of a sealed source beyond its recommended working life (RWL) – up to a period of one additional working life, without the need for prior approval, subject to the following conditions:

wipe or smear tested at 12 month intervals (6 months for portable density/moisture gauges)

all results of wipe or smear tests must be recorded and retained with the source records

In accordance with the Regulatory Guide: Wipe testing of sealed sources and use beyond recommended working life , if the wipe or smear test reveals contamination levels on the closest accessible surfaces to the sealed source in excess of 20 Bq, the source is not considered to be leak tight and should be withdrawn immediately from use

extension must be recorded in the licence holder’s source inventory workbook (SIW).

Any continued use of sealed sources beyond one RWL, other than in accordance with the above, or beyond a second recommended working life will be considered on a case-by-case basis taking into account:

activity of the source

toxicity of the radionuclide and its half-life

source construction

type of dealing

environment in which the source has been/will be used

details on source use

any other inspections or examinations that have been performed (e.g. 6 monthly or annual wipe tests).


https://www.arpansa.gov.au/regulation-and-licensing/licensing/information-for-licence-holders/regulatory-guides#wipe-testing-of-sealed-sources-and-use-beyond-recommended-working-life

https://www.arpansa.gov.au/regulation-and-licensing/licensing/information-for-licence-holders/regulatory-guides#wipe-testing-of-sealed-sources-and-use-beyond-recommended-working-life


Where appropriate, the lead inspector requests further information via email. Meetings or site visits may also be considered.

4.2.2 Expert Advice

Where the change impacts an endorsed security plan, re-endorsement of the plan may be necessary.


The lead inspector prepares an email to the branch head with their recommendation.

4.4 Approval

The Chief Regulatory Officer or delegate may approve an extension of RWL. The lead inspector sends the approval to the applicant by email.

4.5 Record keeping

The lead inspector saves the relevant documents in HPRM and updates LAD.


5. Exemptions



The SSSO will save the application in HPRM, record it in LAD, then forward it to the relevant section director who will assign it to a RO for assessment.

The SSSO acknowledges receipt of the request via email with a copy to the RO.


5.2.1 Agreed assessment time

If no further information is required the RO should agree a timeframe for assessment with the applicant. This should be done by email and must be recorded in ARPANSA’s intranet site. No agreement is required where the assessment is expected to take five working days or less.

5.2.2 Assessment criteria

The RO will take into account the appropriate criteria in the Regulations to determine whether to recommend to the CEO or delegate that an exemption be granted.

5.2.3 Apparatus that produces harmful non-ionising radiation when energised

Under subsection 9(2) of the Regulations the CEO may declare in writing on a case by case basis that an apparatus producing non-ionising radiation is not a controlled apparatus thereby removing the requirement that it be licenced.

The CEO must not declare a non-ionising radiation apparatus exempt unless satisfied that either:

a) the apparatus does not pose an unacceptable potential hazard to the health and safety of people or to the environment

b) it would be inappropriate in all the circumstances for the apparatus to be a controlled apparatus.

The RO assessing an application for exemption must be satisfied that the applicant has provided sufficient evidence for the CEO to conclude that the apparatus meets the criteria under paragraphs (a) or (b) in normal or routine conditions as well as under all reasonably foreseeable abnormal events or conditions.

5.2.4 Prescribed radiation facilities

Under subsection 13(2) of the Regulations the CEO may declare in writing on a case by case basis that a facility is not a prescribed radiation facility (PRF) thereby removing the requirement for licensing of that facility.

The CEO must not declare a PRF exempt unless satisfied that both:

a) the facility does not pose an unacceptable potential hazard to the health and safety of people or to the environment


b) it would be inappropriate, in all the circumstances, for the facility to be a prescribed radiation facility.

The RO assessing an application for exemption must be satisfied that the applicant has provided sufficient evidence for the CEO to conclude that the apparatus meets the criteria under paragraphs (a) and (b) in normal or routine conditions as well as under all reasonably foreseeable abnormal events or conditions.

5.2.5 One or more conducts in relation to a controlled facility

Subsection 43(1) of the Regulations gives the CEO the power to exempt on a case by case basis any of the conducts mentioned in paragraphs 30(1)(a)-(e) of the Act provided it does not or will not pose an unacceptable potential hazard to the health and safety of people or to the environment.

The RO should consider whether the applicant has provided sufficient evidence for the CEO to conclude that the conduct for which the exemption is sought will not pose an unacceptable potential hazard to the health and safety of people and the environment in normal or routine conditions as well as under all reasonably foreseeable abnormal events or conditions.

Note: It is not appropriate to seek/grant an exemption for a conduct that is not proposed/intended. For example, a siting licence is not required for a linac therefore an exemption is also not required.

5.2.6 Dealing with controlled apparatus or controlled material

Dealing with a controlled apparatus or controlled material prescribed in subsection 44(1) of the Regulations is exempt unless declared otherwise under subsection 44(2) because of the risk of excessive dose. If a controlled apparatus or controlled material is not listed in subsection 44(1) the CEO can exempt it provided he/she is satisfied it meets the criteria of a low-dose or low-risk dealing in subsections 44(4) & 44(5) of the Regulations.

Under subsection 44(4) the applicant must demonstrate that for the particular dealing either:

a) The annual effective dose to an individual during normal operations is not likely to exceed 10 Sv

b) An accident, misuse or exceptional circumstance affecting the dealing is not likely to produce a dose greater than the effective dose limits. That is, for occupational exposure—not greater than 20 mSv per year averaged over 5 consecutive calendar years, and not more than 50 mSv in one year; and for the public not greater than 1 mSv annually.

The CEO has determined that the more restrictive of these two tests must be met. In most situations this will be (b) so the RO must ensure there is sufficient information to satisfy the more restrictive requirements before making a recommendation to the CEO or delegate.

The application should include a range of credible events and in the case of controlled material the RO should consider the physical and chemical form and all potential exposure pathways. The application should address:

the potential for exposure during maintenance or repair

shielding

physical barriers

location


method of operation

frequency of use

Under subsection 44(5) the Regulations there are certain low risk dealings that the CEO may declare are exempt:

A radiological emergency or its after-effects The after-effects of a previous dealing Naturally occurring materials Bulk material with a mass of more than 1000 kg.

The applicant must demonstrate that the magnitude of individual doses, the number of people exposed and the likelihood that potential exposure will actually occur justifies the dealing being exempt.


Where necessary, the RO will request further information via email. Meetings or site visits may also be considered.


If satisfied that the applicant has addressed the relevant statutory criteria, the RO prepares an email to the CEO (or delegate) setting out the basis for recommending the exemption.

If the declaration is made under subsection 43(2) of the Regulations, the RO prepares a Notice of Intention to make a declaration under ss43(2) which the CEO must publish in a daily newspaper circulating nationally and on the ARPANSA website prior to making the declaration.

The RO also prepares a Declaration of exemption (from facility licence) under ss43(2) which the CEO must publish on the ARPANSA website as soon as practicable after making the exemption.

If the declaration is made under subsection 44(4) or 44(5) of the Regulations, the RO prepares a Declaration of exemption under ss44(4) or 44(5).

If the declaration is made under subsection 9(2) of the Regulations for NIR apparatus, the RO prepares a Declaration of exemption under ss9(2).

The notice of exemption should state that should circumstances change, then the exemption from the requirement for a source licence may no longer apply.

5.4 Review & Approval

The exemption is subject to the review process described in paragraph 1.5 of this manual.

5.5 Notification

The RO emails the appropriate approval to the applicant.

The RO will arrange for the declaration to be published on the ARPANSA website.

5.6 Record keeping

The RO saves all documentation in HPRM and updates LAD.


5.7 Revocation of exemption

A declaration issued under subsections 9(2), 13(2), 43(2), 44(4) or 44(5) of the Regulations may be revoked by the CEO if the circumstances under which it was issued have changed in such a manner that the controlled person can no longer satisfy the statutory criteria on which it was based.

6. Surrender a licence

6.1 Receipt of application

6.1.1 Receiving a request


Such requests will be either:

seeking approval to surrender a licence and release from regulatory control

seeking approval to surrender a licence and reissue of another licence

The SSSO saves the request in HPRM, records it in LAD and assigns it to the lead inspector.

The SSSO acknowledges receipt of the request via email with a copy to the lead inspector.

6.2 Application assessment

To assist the CEO decide whether to accept the surrender of a source licence, the lead inspector will assess whether the applicant has provided evidence that they will no longer undertake dealings that require a licence. All sources must be transferred or disposed of in accordance with section 63 of the Regulations.

To assist the CEO decide whether to accept the surrender of a facility licence, the lead inspector must ensure that the application will satisfy the CEO that the following circumstances exist in relation to the facility:

a) The remaining structures, systems components and the environment at the location of the facility no longer contain controlled material or the activity concentrations of the remaining material(s) are exempt from regulatory control.

b) Remaining radioactivity levels associated with the facility (i.e. above natural background) do not pose an ongoing danger.

The applicant should demonstrate that the effective dose to a member of the public at the facility’s location is 10 µSv per year or less2. Justification must be provided to deviate from this objective.

Where a request is being made to surrender a decommissioning licence the applicant must account for the full inventory of non-exempt waste arising from the decommissioning process that has been undertaken. The RO must be satisfied that all non-exempt waste is being appropriately managed before recommending the surrender of the licence.

2 IAEA Safety Standards – Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards IAEA General Safety Requirements GSR Part 3 – 2014 (Schedule I, Item I.2)


6.2.1 Further information, including site visits

Where appropriate, the lead inspector requests further information via email. Meetings or site visits may also be considered.

Where appropriate, the lead inspector should request expert advice (see paragraph 1.2.4).


The review of the application should be documented in a file note. If satisfied that the applicant has addressed the guiding principles in Regulatory Guide: Surrender of a Facility Licence and Release from Regulatory Control and/or demonstrated that the source inventory has been appropriately disposed of, the lead inspector will recommend the CEO or delegate consent to the surrender of the licence.

6.4 Review & approval

The application should be subject to the review process in paragraph 1.5 of this manual.

Only the CEO or delegate may approve the surrender of a licence.

6.5 Notification

The lead inspector will send an email to the licence holder consenting to the surrender. The licence holder may also be entitled to a refund of the annual licence charge. This should be confirmed with the relevant section director or Chief Regulatory Officer and the licence holder advised accordingly. The lead inspector should contact Finance to arrange for refund to be processed.

6.6 Record keeping

The lead inspector updates HPRM and LAD.

7. Transport approvals

7.1 Receipt of application


The SSSO will save the application in HPRM, record it in LAD, and forward it to the relevant section director who will assign it to a RO for assessment.

The SSSO acknowledges receipt of the request via email with a copy to the RO.

7.2 Application assessment

ARPANSA is the national competent authority responsible for assessment and approval of applications to transport radioactive material by the commonwealth, in accordance with the Code for Safe Transport of Radioactive Material, Radiation Protection Series No.C-2 (RPS C-2). This includes approval of low dispersible radioactive material, special form radioactive material, design of packages, validation of packages, shipment of radioactive material, radiation protection program for special use vessel and calculation of basic radionuclides value.


https://www.arpansa.gov.au/regulation-and-licensing/regulatory-publications/radiation-protection-series/codes-and-standards/rpsc-2

https://www.arpansa.gov.au/regulation-and-licensing/regulatory-publications/radiation-protection-series/codes-and-standards/rpsc-2

The assessment should be graded in terms of the available information. For example, the safety analysis report (SAR) is a key requirement for certification of design approval for a package and must be provided. However, for validation of a package, if the SAR is not available in English then a synopsis of the SAR and the regulatory assessment of the competent authority in the country of origin may be acceptable depending on the type of package and the availability of supplementary information.

7.2.1 Further information, including site visits

Where necessary, the RO requests further information via email. Meetings or site visits may also be appropriate.

If no further information is required the RO should agree a timeframe for assessment with the applicant. This should be done by email and must be recorded in ARPANSA’s intranet site. No agreement is required if the assessment is expected to take five working days or less.


The lead inspector prepares an assessment report and makes recommendations to the CEO about whether to approve the application. A draft approval certificate is prepared – see the RMS for appropriate template.

7.4 Approval

The CEO must issue any transport approvals as competent authority.

Transport approval is granted for a specific period, for example:

Package Design is generally approved for a period of five (5) years with a possibility of recertification, subject to application

Special Arrangements are approved for a nominated period depending on the type of transport activity

Validation of a package is granted for the period specified in the original certificate and subject to the conditions of the original certificate.

7.5 Final notification

The lead inspector sends the approval to the applicant.

7.6 Record keeping

The lead inspector saves all records in HPRM and updates LAD as necessary.

8. Periodic licence review

Licences are reviewed periodically to ensure they remain current. The review should occur at least once every three years; when the licence template is updated; or if there is a substantial rewrite of licence conditions.


8.1 Review

The lead inspector should complete a licence review checklist. The following items should be checked as part of the review:

8.1.1 Licence template

Check that the licence is in the current format. Licence templates are subject to change as part of continuous improvement within the Regulatory Management System.

8.1.2 Name of licence holder

The name of the licence holder may change over time due to restructuring or merging events.The correct names of Australian Government Departments and Agencies can be found on the Australian Government Online Directory at http://www.directory.gov.au. Details of registered companies may be verified by checking the Australian Securities & Investment Commission internet page at http://www.asic.gov.au.

8.1.3 Licence holder primary contact details

The details of the licence holder’s primary contact should be checked and updated in LAD as required.

8.1.4 Currency of source inventory

Confirm that the SIW on file is current and has been imported into LAD. In cases where an updated SIW has not been received within the last 12 months, a current copy may be requested from the licence holder.

8.1.5 Cross check SIW with licence

The SIW should be cross-checked with the authorised dealings in Schedule 1 of the licence. This may involve checking the description of the item to ensure that it matches the classification in the SIW.

8.1.6 Currency of special licence conditions

Any special licence conditions should be verified and their validity confirmed. Removal of any special condition must be justified with evidence that the condition has been satisfied.

8.2 Documenting the review

The lead inspector should use the checklist to show that they have reviewed the licence file and checked each item. A comment may be placed in the box provided against each item.

Where changes are required, other relevant documents should be referenced.

8.3 Approval

If any changes are made the lead inspector should follow the relevant parts of the procedure for a change under section 63 of the Regulations in section 2 of this manual.

Should the requirement to reissue the licence arise as a result of this review, the lead inspector should follow the process described in section 1 of this manual and advise the licence holder the reason for reissuing the licence.


http://www.asic.gov.au/

http://www.directory.gov.au/

8.4 Record keeping

The lead inspector will:

save the checklist to the licence file in HPRM

update LAD and HPRM as necessary

update the CLB if required

8.5 Further Regulatory Action

Should the review identify a need for further action, the lead inspector should undertake additional actions in consultation with their section director.


Terms and definitionsTerm Definition

Bq becquerel

CEO Chief Executive Officer

CLB Current Licencing Basis

HPRM ARPANSA’s Records Management System

LA Licence Administration

LAD Licence Administration Database

NIR Non-Ionising Radiation

OLC Operational Limits and Conditions

PRF Prescribed Radiation Facilities

RAR Regulatory Assessment Report

RMS Regulatory Management System

RO Regulatory Officer

SAR Safety Analysis Report

SIW Source Inventory Workbook

SSSO Safety Systems Support Officer

Sv Sievert

ReferenceReference/Abbreviation Title Issue date

The Act Australian Radiation Protection and Nuclear Safety Act 1998

Oct 2016

The Regulations Australian Radiation Protection and Nuclear Safety Regulations 2018

Dec 2018

RPS C-2 Code for Safe Transport of Radioactive Material, Radiation Protection Series Publication No C-2

2014

RPS 2.2 Safety Guide for the Approval Processes for the Safe Transport of Radioactive Materials, Radiation Protection Series Publication No 2.2

Nov 2012

REG-LA-SUP-246A Regulatory Guide: Surrender of facility licence and release from regulatory control

Jun 2017

REG-RC-SUP-252A Regulatory Guide: Transfer or Disposal of Sources Aug 2015

REG-COM-MAN-270W Compliance and Enforcement Manual Sep 2018


Introduction - arpansa.gov.au · Web viewThe approved licence and covering letter are converted...

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