Commonwealth Numbered Regulations - Explanatory Statements

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AUSTRALIAN RADIATION PROTECTION AND NUCLEAR SAFETY REGULATIONS 1999 1999 NO. 37

EXPLANATORY STATEMENT

STATUTORY RULES 1999 No. 37

Issued by the Authority of the Minister for Health and Aged Care

Australian Radiation Protection and Nuclear Safety Act 1998

Australian Radiation Protection and Nuclear Safety Regulations 1999

The object of the Australian Radiation Protection and Nuclear Safety Act 1998 (the Act) is to protect the health and safety of people, and to protect the environment, from the harmful effects of radiation. The Act achieves this by providing a regulatory framework in respect of all Commonwealth radiation and nuclear activities. The regulatory framework includes:

§       the establishment of a statutory office - the Chief Executive Officer (CEO) of the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA);

§       a licensing system whereby all Commonwealth entities are required to seek a licence from the CEO, and comply with conditions, with respect to any activities with controlled facilities (nuclear installations and prescribed radiation facilities) and dealings with controlled material and controlled apparatus (ie. radioactive materials and apparatus used for radiation purposes);

§       enforcement provisions whereby the CEO can appoint inspectors to monitor compliance with the legislation (including licence conditions); and

§       establishment of expert advisory bodies including the Radiation Health and Safety Advisory Council and supporting committees, to provide advice to the Minister and the CEO on technical issues, international standards, national codes of practice and other key policy matters related to radiation protection and nuclear safety.

Section 85 of the Act provides that the Governor-General may make Regulations prescribing matters for the purposes of the Act.

The Regulations prescribe.

*       in accordance with section 13 and sub-section 31 (1)(b) of the Act, the type of dealings

       (with controlled apparatus and materials) that are exempt from the application of the

       Act, and the apparatus that are controlled apparatus for the purposes of the Act. In

       relation to apparatus with low levels of hazard, the Regulations provide that these are

       not controlled apparatus for the purposes of the Act and as such they are exempt from

       the regulatory regime described in the Act. Apparatus that produce harmful non

       ionising radiation when energised have been described in the Regulations as controlled

       apparatus and as such are subject to regulation under the Ad (Regulation 4);

*       in accordance with section 13 of the Act, those facilities which together with nuclear

       installations, will be controlled facilities for the purposes of the Act (Regulations 5 and

       6);

*       in accordance with section 13 of the Act, activity levels and activity concentrations over

which nuclear waste storage or disposal facilities and facilities of the production of

radioisotopes will be nuclear installations (Regulations 7 - 11);

*       in accordance with section 29 of the Act, the procedures and operating guidelines for the

Radiation Health and Safety Advisory Council and supporting committees established

under the Act (Regulations 12 - 36);

*       information about the licensing system including:

-       persons who are exempt from requiring a facility licence (as per subsection

30(1)(g) of the Act) (Proposed Regulation 37);

-       prescribed dealings that must be licensed (as per subsection 3 1 (1)(b) of the

Act) (Proposed Regulation 38);

-       information the applicant is required to submit to the CEO in a licence

application and requirements on the CEO to give prior notice and consult on

certain applications. (as per section 34 of the Act) (Proposed Regulations 39

and 40);

-       matters the CEO must take into account when deciding whether a licence

should be granted (as per subsection 32(3) and 33(3) of the Act) (Proposed

Regulations 41 and 42);

-       statutory licence conditions that will apply to all licences (as per subsection

35(1)(b) of the Act). The CEO will also have the capacity to impose additional

conditions in relation to individual licences (Proposed Regulations 43 - 55);

-       practices that must be followed by licence holders. For example, they must

ensure that the doses to which people are exposed do not exceed certain dose

limits described in the regulations (as per subsection 85(2)(a) of the Act)

(Proposed Regulations 56- 62);

*       in accordance with subsection 15(1)(i) of the Act, that the CEO must make guidelines, on matters such as about how the CEO will report on operations, a draft of which must be published by the CEO and made available for public consultation, within 12 months (Proposed Regulation 63); and

*       in accordance with subsection 62(3) of the Act the form of identity cards for inspectors appointed by the CEO (Regulation 64). Further details of the Regulations are set out in the Attachment.

The Regulations commence on gazettal.

ATTACHMENT

DETAILS OF AUSTRALIAN RADIATION PROTECTION AND NUCLEAR SAFETY REGULATIONS

PART 1 - PRELIMINARY

Regulation 1 (Name of Regulations)

This is a formal provision that specifies the title of the Regulations as the Australian Radiation Protection and Nuclear Safety Regulations 1999.

Regulation 2 (Commencement)

This provision provides that the Regulations will commence on gazettal.

Regulation 3 (Definitions - the dictionary)

This provision describes the dictionary which is included at the end of the Regulations and describes words and expressions used in the Regulations or refers to other documents that contain definitions for certain words used in the Regulations. Unless the contrary intention is indicated, the dictionary meaning is to be used for words or expressions appearing in these Regulations.

PART 2 - CONTROLLED APPARATUS AND FACILITIES

DIVISION 1 - Controlled Apparatus

Regulation 4 (Kinds of apparatus that are controlled apparatus)

Section 13 of the Act provides that "controlled apparatus" includes apparatus prescribed in the Regulations that produce harmful non-ionizing radiation when energised. This Regulation identifies controlled apparatus which produce harmful non-ionizing radiation when energised. Controlled apparatus are those apparatus listed in Regulation 4 which exceed exposure limits set out in Schedule 1 of the Regulations and for which it is likely that persons in the vicinity of the apparatus would be exposed to radiation.

Subregulations 4.3 and 4.4 enable the CEO to make a declaration, for publication in the Gazette, which provides that the apparatus noted in the declaration is not a controlled apparatus. DIVISION 2 - Controlled facilities

Regulation 5 (Controlled facility)

Controlled facilities are facilities which require a greater degree of scrutiny, because they represent a higher level of hazard, and a correspondingly higher level of safety is necessary. Nuclear installations (for example, a nuclear reactor and associated plant) are defined in the Act as controlled facilities. There may be other facilities such as accelerators used by industry in connection with medicine and research, which are not nuclear installations but require a similar approach to engineered safety. Regulation 5 enables such facilities to be prescribed as controlled facilities.

Regulation 6 (Prescribed radiation facility)

This Regulation describes the circumstances under which a facility is a prescribed radiation facility for the purposes of the legislation.

Subregulations 6.1 and 6.2 describe a number of different types of facilities which are controlled including certain irrradiators, particle accelerators and facilities used for the production, processing use, storage, management or disposal of radiation sources in excess of multiples of the exemption levels specified in column 4 of Part 2 of Schedule 2. These multiples are 10' for scaled sources and 10' for unsealed sources. The smaller multiple for unsealed materials is due to the greater possibility of dispersion of the material.

Different radioactive materials have greater or lesser potential for hazard, depending on their radiotoxicity. Variations in radiotoxicity are reflected in the exemption levels in Column 4 of Part 2 of Schedule 2 which lists, for all radioactive materials, the quantities in becquerels below which the material is exempt from control (becquerel is a unit of radioactivity). The least hazardous materials have the highest exemption levels.

The multiples have been chosen to give quantities of controlled materials at which experience has shown that there is a potential for significant hazard. For commonly used industrial controlled materials, the multiples would lead to quantities of 1015 or 1012 becquerels respectively for sealed and unsealed sources. These two values are comparable with values in current draft Canadian regulations. More hazardous material, with a corresponding lower exemption value will lead to a facility being prescribed at a corresponding lower inventory.

Subregulations 6.3, 6.4 and 6.5 enable the CEO to make a declaration that certain facilities, as mentioned in the declaration, are not prescribed radiation facilities. For example, if it became apparent that a facility was technically caught by subregulation 6.1 but did not require the level of regulatory oversight appropriate for a controlled facility because of the very low level of risk associated with the facility, the CEO may publish a notice in the Gazette declaring that the facility is not a prescribed radiation facility. The controlled materials and apparatus comprising the facility would however be regulated as sources under section 31 of the Act.

DIVISION 3 - Prescribed activity levels

Regulation 7 (Prescribed activity levels)

This Regulation repeats the definition of nuclear installation stated in section 13 of the Act which provides that Regulations may be made prescribing activity levels in relation to a , nuclear waste storage or disposal facility and a facility for the production of radioisotopes. If the activity of the nuclear waste storage or disposal facility or the facility for production of radioisotopes exceeds the activity prescribed in the Regulations, then the facility is a nuclear installation.

Regulation 8 (Prescribed activity level - nuclear waste storage or disposal facility)

This Regulation sets out numerical values for activity level and activity concentration, above which, a nuclear waste storage or disposal facility will be a nuclear installation. The Regulation provides different numerical values for facilities containing waste that is in the form of sealed sources, unsealed sources and a mixture of sealed and unsealed sources. The levels have been derived from the "Code of Practice for the Near-Surface Disposal of Radioactive Waste in Australia and workplace exposure scenarios used by the International Atomic Energy Agency.

The levels prescribed are intended to include large scale waste storage and disposal facilities and exclude waste storage in small operational areas such as laboratories.

To work out whether the activity level and activity concentration of the materials at a particular facility are in a quantity greater than the applicable level described in this Regulation, the reader is directed to Regulation 9 and 10.

Regulation 9 (How to work out activity and applicable level)

This regulation describes how to work out the activity of a mixture, and its applicable level.

Different radioactive materials have greater or lesser potential for hazard, depending on their radiotoxicity. Variations in radiotoxicity are reflected in Column 4 of Part 2 of Schedule 2 which lists, for all radioactive materials, quantities in becquerels for each radioisotope. To work out the activity of a. mixture, the activity of each controlled material must be divided by the corresponding value for the material listed in column 4, Part 2 of Schedule 2. The fractions are then added and if the total activity is greater than 10 for sealed sources and 106 for unsealed sources then the waste storage or disposal facility that holds the materials will be a nuclear installation for the purposes of the legislation.

Regulation 10 (How to work out activity concentration)

This regulation describes how to work out the activity concentration and its applicable level for the purpose of Regulations 8 and 11.

It is essential that, for waste storage and disposal facilities, both the activity level and activity concentration of controlled materials is worked out and exceeds the prescribed limits before a facility is classified as a nuclear installation. This is necessary so that large quantities of material at low concentrations which do not pose a risk, for example, naturally occurring radioisotopes, are excluded from the definition of a nuclear installation. Facilities handling large quantities of low level materials would continue to be regulated as prescribed facilities or as controlled material but do not require the level of regulatory oversight associated with a nuclear installation.

Regulation 11 (Prescribed activity level - facility for the production of radioisotopes)

This regulation provides that a facility that produces radioisotopes is a nuclear installation if the facility produces a mixture of controlled materials which have an activity quantity greater than the applicable level. The activity quantity of the controlled materials at the facility and the applicable level is worked out using a process which is described in Regulation 9.

PART 3 - THE RADIATION HEALTH AND SAFETY ADVISORY COUNCIL AND ADVISORY COMMITTEES

DIVISION 1 - Radiation Health and Safety Advisory Council

Regulation 12 (Radiation Health and Safety Advisory Council)

This Regulation notes that under the Act, a Radiation Health and Safety Advisory Council is established (section 19), members are appointed in accordance with section 21 and a Chair is appointed in accordance with subsection 21(6). Section 29 of the Act provides that Regulations may prescribe matters relating to the Council and this Division sets out those matters. It should be noted that these Regulations describe only some of the matters relating to the Council. The Council will be expected to develop more detailed operating guidelines.

Regulation 13 (Term of appointment)

This Regulation provides that a Council member is appointed for the term stated in the member's appointment and that term must not be greater than three years. A Council member may, however, be reappointed for further terms of up to three years. The Chair of the Council is also appointed for the term stated in the appointment and may be reappointed for further terms.

Regulation 14 (Resignation)

This Regulation provides that a member may resign by signed notice of resignation given to the Minister.

Regulation 15 (Disclosure of interests)

This Regulation requires all Council members to give the Minister written notice of all interests, pecuniary or otherwise, which could conflict with the member's performance of his/her functions.

With respect to the situation where a member may identify a conflict of interest in relation to a matter under discussion during the course of a meeting, guidelines drafted by the Council will describe the steps to be taken to avoid such a conflict (this might include, for example, a requirement that the member absent him/her self during discussions on the particular issue and abstain from voting).

Regulation 16 (Termination of appointment)

This Regulation describes the circumstances under which the Minister may (i.e. has the discretion to) terminate a Council member's appointment (for example, for incompetence, inefficiency or misbehaviour). It also describes more serious circumstances under which the Minister must terminate a member's appointment (for example, bankruptcy, imprisonment, prolonged absence from meetings without leave). These are circumstances where the Minister has no discretion and must terminate the members appointment.

Regulation 17 (Leave of absence)

This Regulation provides that the Minister may grant leave of absence to the Chair of the Council and the Chair may grant leave to any other member.

Regulation 18 (Council procedures generally)

Subregulation 18.1 sets out general procedures which the Council must observe when carrying out its functions (for example, the Council must act in accordance with the Regulations with as little formality as possible). The Regulation also provides that the Council is not bound by the rules of evidence, may obtain information in any way it considers appropriate, receive written or oral information and consult anyone it considers appropriate.

Subregulation 18.2 provides that the Minister may issue directions to the Council about the Council's performance of its functions and the Council must comply with such directions.

Regulation 19 (Meetings)

Subregulation 19.1 provides that the Minister may direct the Council to hold meetings at any time or place, and to deal with matters in a particular manner, stated in a written notice to the Council. The Minister may, for example, direct the Council to consult with particular interest groups on a particular issue, as part of the Council's consideration of that issue. The subregulation does not provide the Minister with the power to direct the outcome of findings or recommendations of the Council.

Subregulation 19.2 provides that, in the absence of a written notice from the Minister under subregulation 19.1, the Council may hold meetings at times and places of its. choosing, and may deal with matters in the manner that the Council considers necessary for the performance of its functions.

Subregulation 19.3 provides that subject to the above mentioned subregulations, the Council may decide the procedure for Council meetings.

Regulation 20 (Presiding member)

This Regulation provides that the Chair must preside at a Council meeting if he/she is present, and if he/she is absent, the member chosen by the members present must preside.

Regulation 21 (Quorum)

This Regulation provides that at a Council meeting, a majority of members forms a quorum.

Regulation 22 (Voting)

This Regulation provides that a decision made at a Council meeting by a majority of the votes of the members present is considered to be a decision of the Council. This does not mean that all questions arising must be determined by a majority vote. The Council members may choose not to finalise a Council decision until consensus has been reached.

Regulation 23 (Records and reports)

This Regulation provides that the Council must keep a record of its proceedings, prepare an annual report for the CEO and prepare any other reports requested by the Minister or the CEO.

DIVISION 2 - Radiation Health Committee and Nuclear Safety Committee

Regulation 24 (Radiation Health Committee and Nuclear Safety Committee)

This Regulation restates the provisions of the Act which: establish the Radiation Health Committee (section 22) and the Nuclear Safety Committee (section 25); provide for the appointment of Radiation Health Committee members and the Chair (section 24); provide for the appointment of Nuclear Safety Committee members and the Chair (section 27); and provide for Regulations to be made under the Act in relation to the Committees (section 29).

This Division sets out some of the matters relating to the Committees. The information set out in this Division is not exhaustive and the Committees will develop their own detailed operating guidelines.

Regulation 25 (Term of appointment)

This Regulation provides that a Committee member is appointed for the term stated in the member's appointment and that term must not be greater than three years. A Committee member may, however, be reappointed for further terms of up to three years. The Chair of a Committee is also appointed for the term stated in the appointment and may be reappointed for further terms.

Regulation 26 (Resignation)

This Regulation provides that a Commit tee member may resign by signed notice of resignation

given to the CEO.

Regulation 27 (Disclosure of interests)

This Regulation requires all Committee members to give the CEO written notice of all interests, pecuniary or otherwise, which could conflict with the member's performance of his/her functions.

Regulation 28 (Termination of appointment)

This Regulation describes the circumstances under which the CEO may terminate a Committee member's appointment (for example, on the grounds of incompetence, inefficiency or misbehaviour). It also describes the more serious circumstances under which the CEO must terminate a Committee member's appointment (for example, bankruptcy, conviction of an offence punishable by imprisonment for 1 or more years and prolonged absence from meetings without leave).

Regulation 29 (Leave of absence)

This Regulation provides that the CEO may grant leave of absence to the Chair of the Committee and the Chair may grant leave to any other member.

Regulation 30 (Committee procedures generally)

Subregulation 30.1 sets out general procedures which the Committee must observe when carrying out its functions (for example, the Committee must act in accordance with the Regulations and act with as little formality and as quickly as possible). The Regulation also provides that the Committee is not bound by the rules of evidence, may obtain information in any way it considers appropriate, receive written or oral information and consult anyone it considers appropriate.

Subregulation 30.2 provides that the CEO may issue directions to the Committee about the Committee's performance of its functions and the Committee must comply with Such directions.

Regulation 31 (Meetings)

Subregulation 31.1 provides that the CEO or the Council may direct the Committee to hold meetings at the particular times and places, and to deal with matters in a manner directed and set out in a written notice, to the Committee. The CEO or the Council may, for example, direct the Committee to seek the views of particular stakeholders when considering an issue. The subregulation would not permit the CEO or the Council to direct the outcome of findings or recommendations of the Committee.

Subregulation 31.2 provides that, in the absence of a written notice from the CEO or the Council under subregulation 31.1, the Committee may hold meetings at the times and places of its choosing, and may deal with matters in the manner that the Committee considers necessary for the performance of its function.

Subregulation 31.3 provides that subject to these Regulations, the Committee may decide the procedure for Committee meetings.

Regulation 32 (Presiding member)

This Regulation provides that the Chair must preside at a Committee meeting if he/she is present. If he/she is absent, the member chosen by the members present must preside.

Regulation 33 (Quorum)

This Regulation provides that, at a Committee meeting, a majority of members forms a quorum.

Regulation 34 (Voting)

This Regulation provides that a decision of the Committee is a decision made at a Committee meeting by a majority of the votes of the members present. This does not mean that all questions arising must be determined by a majority vote. The Committee members may choose not to finalise a Committee decision until consensus has been reached.

Regulation 35 (Records and reports)

This Regulation provides that a Committee must keep a record of its proceedings and prepare any report requested by the CEO or the Council. Further, if a Committee prepares a report on any matter, the Committee must give copies of the report to the CEO and to the Chair of the Council.

Regulation 36 (Existing codes - revision)

This Regulation provides that where a Committee revises a nuclear code, originally developed under the Environment Protection (Nuclear Codes) Act 1978, the revision must be notified in a national newspaper and tabled in Parliament as part of the CEO's next quarterly report. This ensure that people are adequately informed about any changes to the codes.

PART 4 - LICENCES

DIVISION 1 - Exemptions

Regulation 37 (Exempt people (facility licence))

Under subsection 30(1) of the Act, a controlled person is prohibited from preparing a site for, constructing, possessing, controlling, operating, decommissioning, disposing of or abandoning a controlled facility, unless the person is authorised to engage in any of these activities under a facility licence or is exempt from requiring an authorisation under a facility licence for the particular activity (conduct).

This Regulation gives the CEO power to declare that actual or prospective conduct relating to a controlled facility is not an unacceptable potential hazard to the health and safety of people or to the environment and as such, the controlled person is exempt from complying with the Act in relation to such conduct. For example, authorisation to prepare a site may not be required if it is demonstrated that the facility will not lead to an unacceptable hazard to people or the environment outside the facility.

Subregulation 37.1 reiterates subsection 30(1) of the Act which enables Regulations to be made to exempt a controlled person from having to have an authorisation under a facility licence in order to conduct particular activities at the controlled facility.

Subregulation 37.2 provides that the CEO may make a declaration that conduct, including future conduct, relating to a controlled facility is not, or will not be, an unacceptable potential hazard to the health and safety of people or to the environment.

Subregulation 37.3 provides that the CEO may state in the declaration that the exception will only have effect in certain circumstances. This provision effectively allows the CEO to set conditions (for example, timeframes) in association with the exemption.

Subregulations 37.4, 37.5 and 37.6 provide that the CEO must publish the declaration in the Gazette as soon as practicable after making it and the effect of publishing the declaration is to exempt the controlled person in relation to all of the conduct mentioned in the declaration, relating to the controlled facility, provided that the circumstances in subregulation 37.3 are satisfied.

Regulation 37A (Notice of intention to make a declaration)

This Regulation requires the CEO to publish in the Gazette, his/her intention to make a declaration under subregulation 37.2. The gazette notice must include a copy of the declaration, a description of the conduct and the facility to be exempted and, if applicable, any limitations on the declaration.

Regulation 38 (Prescribed dealings (source licence))

Further to subsection 31(1) of the Act, this Regulation provides that a dealing with a controlled material or controlled apparatus, by a controlled person, is exempt from the requirement to be authorised under a source licence if it is described in Part 1 of Schedule 2.

Subregulations 38.3 and 38.4 provide that, even if the dealing is described in Part 1 of Schedule 2 and is therefore exempt, the CEO may make a declaration that the dealing is not exempt. The CEO may make such a declaration if the dealing is likely to give rise to a significant annual effective dose to an individual or to the population, or if accident or misuse affecting the dealing is likely to produce a dose greater than the effective dose limit.

Subregulation 38.5 enables the CEO to declare in writing that certain dealings that are not described in Part 1 of Schedule 2 are exempt. The CEO would make such a declaration if the annual effective dose to an individual is low (not more than 10 micro.Sv) or if an accident or misuse affecting the dealing is not likely to produce a dose greater than the effective dose limit or if the annual effective dose to the population committed as a result of one year of the dealing is likely to be not more than 1 man. Sv. The doses prescribed in this provision are those published by the International Atomic Energy Agency as not requiring regulatory control.

Subregulation 38.6 enables the CEO to make a declaration that certain dealings involving a radiological

emergency or its effects, of the after effects of a previous dealing or naturally occurring material or bulk

material with a mass of more than 1,000 kg may be exempt. The CEO may only make such a

declaration after assessing the magnitude of individual doses, the number of people exposed and the

likelihood that potential exposure will actually occur, and determining that these things justify the

dealing being exempt. This subregulation may be used by the CEO to, for example, exempt the

Maralinga site after the clean-up exercise or exempt collections of rocks which do not present a danger

in terms of exposures likely to be incurred by individuals.

Subregulation38.7 provides that the effect of a declaration made under subregulation 38.5 or 38.6 is to exempt the dealing from the operation of the legislation.

Subregulations 38.8 provides that the CEO must publish in the Gazette declaration made under subregulation 38.3, 38.5 or 38.6 as soon as practicable after making it.

DIVISION 2 - Applications for licences

Regulation 39 (Application form)

Subregulation 39.1 states that, under section 33 of the Act, an application for a facility licence or a source licence must be in a form approved by the CEO.

Subregulation 39.2 provides that the CEO may request applicants for a facility licence to provide some or all of the information in Part 1 of Schedule 3 and any other information that is appropriate in relation to the particular application.

Subregulation 39.3 provides that the CEO may request applicants for a source licence to provide some or all of the information in Part 2 of Schedule 3 and any other information that is appropriate in relation to the particular application.

Subregulation 39.4 states that any application for a licence by a Department or Commonwealth body must be in the name of the Department or body and made by the Secretary, Chief Executive or equivalent person, or a person authorised to do this by the Secretary, Chief Executive or equivalent person.

Regulation 40 (Issue of facility licence - prior notice and consultation)

The Regulation states that when the CEO receives an application for a facility licence he/she must, as soon as practicable, publish a notice stating that the CEO intends to make a decision on the application. The notice must be published in the government Gazette, in a ' national newspaper and in a newspaper circulating in the area in which the facility is located. If the application relates to a nuclear installation, the notice must invite individuals and organisations to make submissions about the application and describe the timeframe and process for making submissions.

DIVISION 3 - Deciding whether to issue licence

Regulation 41 (Issue of facility licence - matters to be taken into account by CEO)

This Regulation describes the matters the CEO must take into account when assessing an application for, and deciding whether to issue, a facility licence. In essence, the matters stated in subregulation 41.3 relate to whether the applicant has demonstrated that the facility will not present an unacceptable hazard to the health and safety of people and to the environment, that the conduct relating to the facility has a net benefit, and whether the applicant has shown a capacity for complying with the regulations and the licence conditions. The CEO must also take into account the content of any submissions made by members of the public about proposed conducts at nuclear installations.

Regulation 42 (Issue of source licence - matters to be taken into account by CEO)

This Regulation describes the things the CEO must take into account when assessing an application for a source licence. The matters stated in subregulation 3 8.3 relate to whether the applicant has demonstrated that dealing with the controlled material or controlled apparatus will not present an unacceptable hazard to the health and safety of people and to the environment, and whether the applicant has shown a capacity for complying with the regulations and the licence conditions.

DIVISION 4 - Licence conditions

Regulation 43 (Purpose of Division)

This Regulation provides that under paragraph 35(1)(b) of the Act, a facility or source licence is subject to conditions prescribed by the Regulations. Division 4 of the Regulations prescribes these conditions.

Regulation 44 (Holder of a licence must prevent breaches of conditions)

This Regulation provides that a licence holder must prevent breaches of licence conditions by taking all reasonably practicable steps to achieve this end.

Regulation 45 (Holder of a licence must investigate and rectify breaches of conditions)

Subregulations 45.1 and 45.2 provide that any breach or suspected breach of licence conditions must be investigated by the licence holder who must rectify the breach and any consequences of the breach as soon as reasonably practicable.

Subregulation 45.3 Provides that the holder of the licence must notify the CEO about the breach as soon as reasonably practicable.

Regulation 46 (Holder of a licence to prevent, control and minimise accidents)

Subregulation 46.1 provides that the holder of the licence must take all reasonably practicable steps to prevent accidents involving controlled materials, apparatus or facilities covered by the licencee's licence.

Subregulation 46.2 provides that if an accident occurs, the holder of the licence must take all reasonably practicable steps to control the accident and minimise the consequences of the accident. The holder of the licence must also notify the CEO about the accident within 24 hours, and provide a written report within 14 days of the accident.

Regulation 47 (Compliance with National Standard for Limiting Occupational Exposure to Ionizing Radiation)

This Regulation provides that the holder of a source or facility licence who deals with controlled materials, apparatus or facilities that generate ionizing radiation, must comply with the "National Standard for Limiting Occupational Exposure to Ionizing Radiation". These standards were published jointly by the National Health and Medical Research Council and the National Occupational Health and Safety Commission and have been adopted nationally in Australia. The Regulation does not apply to non-ionizing radiation apparatus.

Regulation 48 (Compliance with Recommendations and Codes of Practice)

Subregulation 48.1 provides that this regulation does not apply to conduct and dealings with nonionizing radiation apparatus as described in Regulation 4. This is because the Recommendations and Codes of Practice described in the Regulation relate only to ionizing radiation and are not applicable to non-ionizing radiation apparatus

Subregulation 48.2 provides that source and facility licence holders must ensure that conducts or dealings with controlled materials, apparatus and facilities are in accordance with the Recommendations for limiting exposure to ionizing radiation and the Code of Practice for the Safe Transport of Radioactive Substances. The Recommendations and Code of Practice are derived from international recommendations and have been adopted nationally.

Subregulation 48.3 provides that source and facility licence holders must ensure that dealings with the disposal of controlled material and controlled apparatus are in accordance with certain Codes of Practice. The Codes of Practice which are outlined in the Regulations have been adopted nationally.

Regulation 49 (Compliance with plans for managing safety)

This Regulation provides that licence holders must comply with their plans and arrangements for managing safety, as described in their licence application. Normally, plans for managing safety will be developed by the licence holder. Their development may be iterative and their final form will be agreed between the licence holder and the CEO of ARPANSA. Not all controlled apparatus or controlled materials will necessarily require detailed plans for managing safety.

Regulation 50 (Holder of a licence must review and update plans and arrangements)

Subregulation 50.1 provides that plans and arrangements for managing controlled facilities, apparatus or materials must be reviewed and updated by the licence holder as appropriate, but at least once a year. This is important for ensuring that the licencee's safety arrangements for the source or facility remain current and any changes, additions or deletions are reflected in documentation.

Subregulation 50.2 provides that the outcome of the review must be notified to the CEO.

Regulation 51 (CEO approval for relevant changes)

This Regulation states that relevant changes that will have significant implications for safety must not be made to the facility or source arrangements without prior approval of the CEO. The term 'relevant changes' is defined in the Dictionary as meaning a change to the details in the application for the licence or a modification of the source or facility mentioned in the licence.

Regulation 52 (Holder of a licence must tell CEO about other changes)

This Regulation provides that changes which are unlikely to have significant implications for safety do not require prior approval of the CEO but must be communicated to the CEO at least once every three months. The CEO may, however, state in the conditions of licence that other arrangements are to be in place in relation to notification of changes.

Regulation 53 (Holder of a licence must tell CEO about movement of controlled apparatus, controlled materials and controlled facilities)

Subregulation 53.1 provides that a licence holder must obtain the approval of the CEO before disposing of controlled apparatus and controlled material. The requirement of prior approval recognises the potential seriousness of disposing of controlled apparatus or materials and the need for the CEO to ensure that appropriate safety measures are in place.

Subregulation 53.2 provides that the holder of a licence must notify the CEO, within 7 days, of the transfer of controlled apparatus or controlled materials to someone else. The licence holder must provide information to the CEO about the transfer including the name of the person or body to whom the material or apparatus has been transferred, the number of the licence held by that person and the new location of the materials or apparatus.

Subregulation 53.3 provides that a licence holder must obtain the approval of the CEO before disposing of, or transferring control of, a controlled facility.

Subregulation 53.4 provides that subregulations 53.1, 53.2 and 53.3 do not apply to the extent that the licence makes other arrangements. This means that the CEO may include in the licence, conditions which impose more or less onerous approval or reporting procedures for licence holders disposing of, or transferring, controlled apparatus, materials or facilities.

Regulation 54 (Holder of a licence must seek approval to construct safety item)

Before constructing structures, systems or components important to safety in a controlled facility, and identified in a safety analysis report, the holder of the licence must obtain the prior approval of the CEO.

Regulation 55 (Holder of a licence must not load nuclear fuel without approval)

This Regulation provides that nuclear fuel must not be loaded into a controlled facility, as part of the construction of the facility, without the prior approval of the CEO.

PART 5 - PRACTICES TO BE FOLLOWED

Regulation 56 (Purpose of Part)

This Regulation restates subsection 85(2)(a) of the Act which provides that Regulations may be made requiring controlled persons to observe specified standards, practices or procedures in activities relating to controlled facilities or dealings with controlled materials or controlled apparatus. This Part of the Regulations describes a prescribed practice.

Regulation 57 (Application of Part)

This Regulation provides that Part 5 of the Regulations only applies if it does not require the holder of a licence to do something contrary to the provisions of the Sex Discrimination Act 1984. Any holder of a licence who cannot comply with a licence because to do so would contravene the Sex Discrimination Act 1984, is exempt from the operation of the Australian Radiation Protection and Nuclear Safety Act 1998.

Regulation 58 (Prescribed practice)

This Regulation provides that in relation to facilities at which controlled material is present and dealings with controlled apparatus and controlled material, effective doses to which persons are exposed must be controlled by the holder of a licence so that they do not exceed the effective dose limits in Regulation 59 and the equivalent dose Emits in Regulation 62. These dose limits are those recommended by the NHMRC, which are in turn based on the limits recommended by the International Commission on Radiological Protection (ICRP) and adopted throughout the developed world.

Subregulation 58.4 further provides that for controlled facilities, apparatus and materials, the holder of a licence must ensure that radiation protection and safety are optimised so that individual doses, the number of people exposed, and the likelihood of incurring exposures to radiation are as low as reasonably achievable after taking into account social and economic factors. This condition will ensure that radiation doses from controlled facilities, material and apparatus are as far below limits as is reasonably achievable, in line with the recommendations of the NHMRC and ICRP.

Subregulation 58.5 provides that the optimisation referred to in subregulation 58.4 must be in accordance with source-related dose constraints established in accordance with the Recommendations for limiting exposure to ionizing radiation and agreed by the CEO. The values of dose constraints must be agreed by the CEO and will be set so as to ensure that the addition of doses arising from multiple sources of radiation will not result in doses to individuals exceeding the limits described above. The values of the constraints will also reflect best practice by taking into account what is achievable at similar, well run practices.

Subregulation 58.6 provides that for prescribed non-ionizing radiation apparatus, the licence holder must ensure that exposure to people is kept to the lowest level that can be achieved, consistent with best practice.

Regulation 59 (Effective dose limits)

This Regulation describes the effective dose limits for workers and for members of the public.

These are taken from limiting exposure to ionizing radiation (1995)" and 'National standards for

limiting occupational exposure to ionizing radiation", Radiation

Health Series No 39, published by the National Health and Medical Research Council.

Regulation 60 (Effective doses)

This Regulation provides that a person's effective dose is the sum of the effective dose from external exposure and the effective dose from internal exposure (ie. inside the body) computed for the next 50 years as a result of the retention of controlled material in the body. If a person is less than 18 years of age, the committed effective dose is calculated to age 70.

Regulation 61 (Dealings with controlled apparatus generating non-ionizing radiation)

This Regulation provides that the holder of a source licence must ensure that all dealings with prescribed non-ionizing radiation apparatus must comply with the exposure limits set out in the standards and codes mentioned in Schedule 1.

Regulation 62 (Annual equivalent dose limit)

The application of effective doses to the whole body could lead to undesirably high levels of dose to the lens of the eye, the hands, the feet and the skin. Separate equivalent dose limits are therefore given for these tissues, and different limits apply for occupational exposure and public exposure.

These are taken from "Recommendations for limiting exposure to ionizing radiation (1995)" and National standard for limiting occupational exposure to ionizing radiation", Radiation Health Series No 39, published by the National Health and Medical Research Council.

PART 6 - REPORTING AND INSPECTION FOR CONTROLLED FACILITIES, APPARATUS AND MATERIALS

Regulation 63 (Reporting guidelines to be published by CEO)

This Regulation requires the CEO to make guidelines about how the CEO will report on the operations of the Agency, how licence holders will report their compliance with the ARPANS legislation, and how inspection of controlled facilities, controlled apparatus and controlled materials will be conducted. The CEO is given 12 months from the commencement of the Regulations to develop and publish a draft of the Guidelines and invite public comment on such guidelines. This provision ensures that the procedures and practices to be followed by the Agency will be open to public scrutiny and will benefit from community input.

Regulation 64 (Inspector's identity card)

This Regulation provides that inspectors appointed by the CEO under section 62 of the Act must be issued with an identity card in the form set out in Schedule 4.

SCHEDULE 1 - EXPOSURE LIMITS FOR NON-IONIZING RADIATION

Regulation 4 provides that apparatus is controlled apparatus if it produces non-ionizing radiation in excess of the exposure limits mentioned in Schedule 1 and if it is readily accessible to persons in a number of different circumstances (described in that Regulation).

This Schedule therefore describes the various exposure limits for non-ionizing radiation by reference to Australian standards, or national/international publications. The references used reflect international best practice.

SCHEDULE 2 - EXEMPT DEALINGS

PART 1 - DEALINGS

This Part describes different types of dealings (with controlled apparatus or controlled materials) which will be exempt from the operations of the Act. The materials and apparatus listed in the Schedule have been exempted on the grounds that they do not pose any significant risk to the health and safety of people or to the environment.

PART 2 - EXEMPTION LEVELS: EXEMPT ACTIVITY CONCENTRATIONS AND EXEMPT ACTIVITIES OF RADIONUCLIDES (ROUNDED)

Items 1 and 2 in Part 1 of Schedule 2 provide that a dealing with a controlled material will be exempt on the basis of the activity concentration or activity of the material. This Schedule lists the activities or activity concentrations below which controlled materials are exempt, because of their low radiological risk under normal circumstances.

PART 3 - NUCLIDES AND PROGENY

Part 3 identifies the radioactive species and their decay products (progeny) which are also radioactive where the sequence of decay products have been taken into account in determining the values in the table in Part 2 of the Schedule. The table is based on a table published in the Basic Safety Standards issued by the International Atomic Energy Agency.

PART 4 - QUANTITIES OF RADIOACTIVE SUBSTANCES IN TIMEKEEPING AND OTHER DEVICES

Part 4 tabulates the controlled materials used in time keeping and other luminous devices, and the quantities below which these are exempt.

SCHEDULE 3 - INFORMATION THAT MAY BE REQUESTED BY THE CEO

PART 1 - FACILITY LICENCE

Part 1 of Schedule 3 sets out the information which the CEO may request an applicant to provide in respect of an application for a facility licence. The Part is divided into a number of sections:

       general information (that may be requested from all applicants);

       information about authorisations for preparing a site for a controlled facility;

       information about constructing a controlled facility;

       information about possession or control of a controlled facility;

       information about operating a controlled facility;

       information about de-commissioning a controlled facility; and

       information about abandoning a controlled facility.

The CEO may request some or all of the information and documents in this Part (depending on the type of facility for which a licence is sought and the particular conduct for which authorisation is sought) and may request any other information that is appropriate.

PART 2 - SOURCE LICENCE

Part 2 of Schedule 3 sets out the information which the CEO may request an applicant to provide in respect of an application for a source licence. The CEO may request some or all of the information and documents in this Part and may request any other information that is appropriate.

SCHEDULE 4 - IDENTITY CARD

For the purposes of subsection 62(3) of the Act, this Schedule sets out the exact format for the identity cards that will be worn by inspectors appointed. by the CEO of ARPANSA.

DICTIONARY

The dictionary sets out a number of definitions for words and expressions that are used in the Regulations. The dictionary supplements the definitions in section 13 of the Act and relates specifically to the usage of the words and expressions in the Regulations.

For example, where the short title of a Code of Practice or a national standard is used in the Act, the full citation is provided in the dictionary.


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