management-licence-compliance

Introduction

Under s6 of the Protection from Harmful Radiation Act 1990 (the Act) a person responsible for regulated material must hold a radiation management licence in respect to the regulated material and must comply with any conditions to which the licence is subject.

Obligation of responsible person

The definition of a responsible person is defined under s.6 of the Act.

The person responsible for regulated material must ensure that all regulated material, required to be tested by the EPA, is periodically compliance tested by an EPA-accredited consulting radiation expert (CRE). This is 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 management licensing 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.

The licensee must ensure that diagnostic imaging apparatus and sealed source devices which are fixed radiation gauges, referred to in the management licence conditions, remain under an unbroken/continued state of compliance certification.

Diagnostic imaging apparatus

The responsible person must ensure that diagnostic imaging apparatus of the type listed in the management licence conditions for which the licensee is responsible is certified by an EPA accredited CRE as complying with the requirements of Schedule 1, 2 or 3 of the corresponding part of Radiation Standard 6 - Compliance requirements for ionising radiation apparatus used in diagnostic imaging as published by the EPA from time to time:

before the apparatus is used, or
within one year of the anniversary of initial compliance certification for mammography apparatus' or
Within two years of the anniversary of initial compliance certification for fluoroscopy apparatus, computed tomography apparatus and for apparatus that may be used for both fluoroscopy and radiography, or
within five years of initial certification for dental radiography apparatus, radiography apparatus and bone mineral density apparatus, or
if modifications have been made that affect the compliance of the apparatus with the requirements of Schedule 1, 2 or 3 of the relevant Standard, 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, a certificate is required in relation to mean glandular dose requirements following any service or modification that may affect patient dose.

If a CRE certifies that radiation apparatus generally complies with mandatory requirements, but has specified that minor repairs are necessary so that the requirements of Schedule 1, 2 or 3 of the relevant Part of Standard 6 are met, the licensee must:

ensure that these repairs are carried out within the timeframe specified by the CRE, and
adhere to any restrictions on the use or operation of the apparatus specified by the CRE 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 should 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: Guideline 7 applies to newly constructed premises and to premises where changes to the existing building, regulated material, or the use of surrounding areas has occurred.

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 CoC 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

A person must not carry on any of the activities prescribed as activities of a CRE unless they have been accredited by the EPA as a CRE under the Act. The Protection from Harmful Radiation Regulation 2013prescribes the activities of a CRE.

The type of regulated material that a CRE may assess for compliance against the relevant mandatory requirements depends on the conditions of accreditation that the EPA has issued to the CRE. A CRE can only undertake activities as provided in their conditions of accreditation.

The CRE assessing regulated material must keep copies of the NSW CoC for EPA auditing purposes.

See Accredited CREs for a list of EPA accredited CREs or use the EPA public licensing register to search for an accredited CRE.

Certificate of Compliance

NSW compliance certificates for certain regulated material are a requirement of the management licence conditions and include:

the period between CRE CoC testing
certification required for new equipment
certification required for changes to equipment.

New management licence 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.

The EPA does not retain a copy of CoC. The licensee is required to keep copies of certificates at the premises for EPA auditing purposes.

Transfer of apparatus and disposal of apparatus

The 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 submitting the relevant details to the EPA.
the management licence holder giving away or selling the assets must remove those assets from management licence by submitting 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 management licence. Variations to a management licence must be made using eConnect EPA.

Radiation management licence - compliance certification and record keeping