Radiation management licence - compliance certification and record keeping

Introduction

During the transition from registration to management licences, the responsible persons must ensure that regulated material remains under an unbroken state of compliance certification (see s.6 of the Radiation Control Act 1990 for a definition of 'responsible person').

The person responsible for regulated material must ensure that all regulated material required to be tested by the EPA is periodically tested by an EPA-accredited consulting radiation expert (CRE) to ensure that the regulated material meets the minimum requirements as set out by the conditions on the management licence. The CRE issues a NSW Certificate of Compliance (CoC) to the responsible person verifying that the regulated material meets the requirements.

The responsible person and the CRE must keep copies of the NSW CoC for EPA auditing purposes.

A CoC issued by any other jurisdiction for any diagnostic medical apparatus or fixed radiation gauge is not valid for any apparatus being used in NSW. This means that all apparatus sold, loaned, demonstrated and/or transferred for use in NSW from any other jurisdiction must have a valid NSW CoC.

The purpose of periodic testing of regulated material is to help minimise exposure to occupationally exposed persons and the general public from harmful radiation and to promote best practice.

Obligation of responsible person

The licensee must ensure that diagnostic imaging apparatus and sealed source devices which are fixed radiation gauges, referred to in the Management Licence Conditions (the Conditions), remain under an unbroken state of compliance certification during the transition from the requirements of the Radiation Control Regulation 2003 to the Radiation Control Regulation 2013.

Diagnostic imaging apparatus

The licensee must ensure that diagnostic imaging apparatus of the type listed in the Conditions for which the licensee is responsible is certified by an accredited CRE as complying with the requirements for registration in Schedule 1 of the corresponding part of Radiation Guideline 6 - Registration requirements & industry best practice for ionising radiation apparatus used in diagnostic imaging (listed in the Conditions), as published by the EPA from time to time:

  • before the apparatus is used, or
  • within either two or five years of the anniversary of initial compliance certification depending on the type of apparatus as specified in the Conditions, or
  • if modifications have been made that affect the compliance of the apparatus with the requirements of Schedule 1 of the relevant Guideline, or
  • if the apparatus has been relocated and reassembled, or
  • where the purpose for which the apparatus is used has changed, or
  • in addition, in the case of mammography apparatus, an annual certificate is required in relation to mean glandular dose requirements or following any service or modification that may affect patient dose.

If a consulting radiation expert certifies that radiation apparatus generally complies with mandatory requirements, but has specified that minor repairs are necessary so that the requirements of Schedule 1 of the relevant Part of Guideline 6 are met, the licensee must

  • ensure that these repairs are carried out within the timeframe specified by the consulting radiation expert, and
  • adhere to any restrictions on the use or operation of the apparatus specified by the consulting radiation expert until the repairs have been carried out.

Fixed radiation gauges

The licensee must ensure that a sealed source device, which is a fixed radiation gauge for which the licensee is the person responsible, is certified compliant by a CRE accredited by the EPA with the mandatory requirements published by the EPA

  • before it is used, and
  • every two years before the anniversary of its initial compliance certification.

Premises shielding

The licensee must ensure that premises where regulated material for which the licensee is the person responsible is kept or used comply with the requirements in Radiation Guideline 7: Radiation: shielding design assessment and verification, published by the EPA.

Note: This condition only applies to newly constructed premises and to premises previously used for purposes other then keeping or using regulated material.

Record keeping

The following records must be kept in relation to regulated material for which the licensee is the person responsible

  • maintenance reports and summaries of quality assurance and/or wipe tests undertaken on any sealed radioactive source or sealed source device
  • reports and NSW certificates of compliance issued by a CRE in relation to any radiation apparatus or fixed radiation gauge
  • the source certificate for any sealed radioactive source.

The licensee must

  • maintain records in legible form or in a form that can be readily reproduced in a legible form, and
  • keep all records relating to regulated material for a period of two years after the disposal of the source or equipment, or in the case of unsealed radioactive substances for two years after discharge
  • provide all records relating to regulated material to the person to whom the regulated material is transferred, in the case of sale or giving away.

Consulting radiation experts

The role of CREs under the management licensing system remains largely unchanged other than for some minor changes in respect of NSW Certificates of Compliance.

Certificate of Compliance

After 1 July 2013, NSW compliance certificates will continue to be required, but as a condition of management licences. However, the EPA will no longer receive a copy of the certificate, as it does under the pre-1 July 2013 scheme where individual pieces of equipment are registered. The licensee will continue to be required to keep copies of certificates.

All current conditions of a registration relating to compliance testing will still be applied under the management licence conditions, including the period between CRE certificate of compliance testing and certification required for new equipment and changes to equipment. New applications and annual renewals will require that the applicant/licensee confirm that each applicable item of regulated material is certified at the time of application.

Transfer of apparatus and disposal of apparatus

The new legislation does not permit the transfer of management licences.

Where all the items of regulated material are being relocated from a management licence holder to another legal entity, there are a number of steps to be followed

  • The other legal entity must hold a current management licence before it takes possession of the items of regulated material.
  • The EPA must be notified of the relocation of the items.
  • The management licence holder taking possession of the assets must add those assets to their management licence by sending the relevant details to the EPA.
  • The management licence holder giving away or selling the assets must remove those assets from management licence by sending the relevant details to the EPA.

The transferring of regulated material from one management licence to another is usually considered an application to vary an existing licence and will require the completion of a licence variation form.

A CoC issued by any other jurisdiction for any diagnostic medical apparatus or fixed radiation gauge is not valid for any apparatus being used in NSW. This means that all apparatus sold, loaned, demonstrated and/or transferred for use in NSW from any other jurisdiction must have a valid NSW CoC.

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