Radiological Protection (Amendment) Act 2018

PART 1 Preliminary and General

1. Short title, collective citation and commencement

1. (1) This Act may be cited as the Radiological Protection (Amendment) Act 2018.

(2) This Act (other than Part 3, in so far as it relates to the Containment of Nuclear Weapons Act 2003, and Part 4) and the Radiological Protection Acts 1991 to 2014 may be cited together as the Radiological Protection Acts 1991 to 2018.

(3) This Act shall come into operation on such day or days as the Minister may by order or orders appoint either generally or with reference to any particular purpose or provision and different days may be so appointed for different purposes or different provisions.

2. Definitions

2. In this Act—

“enactment” means—

(a) an Act of the Oireachtas,

(b) a statute that was in force in Saorstát Éireann immediately before the date of the coming into operation of the Constitution and that continues to be of full force and effect by virtue of Article 50 of the Constitution, or

(c) any instrument made under an Act of the Oireachtas or a statute referred to in paragraph (b);

“Minister” means the Minister for Communications, Climate Action and Environment;

“Principal Act” means the Radiological Protection Act 1991;

“vesting day” means—

(a) in Part 3, the day appointed as the vesting day for the purposes of that Part by the Minister under section 23, and

(b) in Part 4, the day appointed as the vesting day for the purposes of that Part by the Minister under section 31.

PART 2 Amendment of Principal Act

3. Amendment of section 2 of Principal Act

3. Section 2 of the Principal Act is amended—

(a) by the substitution of the following definition for the definition of “activity”:

“ ‘activity’ (A), other than in relation to a human activity and a relevant activity, is the activity of an amount of radionuclide in a particular energy state at a given time. It is the quotient of dN by dt, where dN is the expectation value of the number of nuclear transitions from that energy state in the time interval dt:

A=dN/dt

The unit of activity is the bequerel (Bq);”,

(b) in the definition of “medical or dental application”, by the substitution of “radiation sources” for “radioactive substances, nuclear devices or irradiating apparatus”,

(c) by the substitution of the following definition for the definition of “radioactive substance”:

“ ‘radioactive substance’ means any substance that contains one or more radionuclides the activity or activity concentration of which cannot be disregarded from a radiation protection point of view;”,

(d) in the definition of “radiological hazards”, by the substitution of “and radiation sources” for “, radioactive substances, nuclear devices and irradiating apparatus”, and

(e) by the insertion of the following definitions:

“ ‘accelerator’ means equipment or installation in which particles are accelerated, emitting ionising radiation with energy higher than 1 mega-electron volt (MeV);

‘Agency’ means the Environmental Protection Agency;

‘apprentice’ means a person receiving training or instruction within an undertaking with a view to the person concerned exercising a specific skill;

‘authorisation’ means registration or a licence;

‘carers and comforters’ means individuals knowingly and willingly incurring an exposure to ionising radiation by helping, other than as part of their occupation, in the support and comfort of individuals undergoing or having undergone medical exposure;

‘European act’ has the meaning given to it by section 8(3) of the European Union Act 2009;

‘exposure’ means the act of exposing or condition of being exposed to ionising radiation emitted outside the body (external exposure) or within the body (internal exposure);

‘licence’ means a licence granted by the Agency pursuant to regulations made under section 30 to permit a person to carry out, subject to the conditions (if any) specified in the licence, the relevant activity in respect of which the licence is granted;

‘licensee’ means a person to whom a licence is for the time being granted;

‘medical exposure’ means exposure incurred by patients or asymptomatic individuals as part of their own medical or dental diagnosis or treatment and intended to benefit their health as well as exposure incurred by carers and comforters and by volunteers;

‘members of the public’ means individuals who may be subject to public exposure;

‘non-medical imaging exposure’ means any deliberate exposure of humans for imaging purposes where the primary intention of the exposure is not to bring a health benefit to the individual being exposed;

‘normal exposure’ means exposure expected to occur under the normal operating conditions of a facility or human activity (including maintenance, inspection, decommissioning) including minor incidents that can be kept under control, that is to say, during normal operation and anticipated occupational occurrences;

‘occupational exposure’ means exposure of workers, apprentices and students incurred in the course of their work;

‘planned exposure situation’ means an exposure situation that arises from the planned operation of a radiation source or from a human activity which alters exposure pathways so as to cause the exposure or potential exposure of people or the environment and may include both normal exposures and potential exposures;

‘potential exposure’ means exposure that is not expected with certainty but may result from an event or sequence of events of a probabilistic nature, including equipment failures and operating errors;

‘practice’ means a relevant activity that is managed as a planned exposure situation;

‘public exposure’ means exposure of individuals excluding occupational or medical exposure;

‘radiation generator’ means a device capable of generating ionising radiation such as x-rays, neutrons, electrons or other charged particles including irradiating apparatus and nuclear generators;

‘radiation source’ means an entity that may cause exposure such as by emitting ionising radiation or by releasing radioactive material and encompasses a radiation generator, radioactive material, radioactive source and radioactive substance;

‘radioactive material’ means material incorporating radioactive substances;

‘radioactive source’ means a radiation source incorporating radioactive material for the purpose of utilising its radioactivity;

‘registered person’ means a person to whom a registration is for the time being granted;

‘registration’ means registration of a relevant activity granted by the Agency pursuant to regulations made under section 30 to permit a person to carry out, subject to the conditions (if any) attached to the registration, the relevant activity;

‘relevant activity’ means a human activity which can increase the exposure of individuals to radiation from a radiation source and includes the custody, production, processing, handling, holding, storage, use, recycling, manufacture, import, distribution, transport, export or other disposal of the radiation source;

‘undertaking’ means a person who has legal responsibility for the carrying out of a practice or for a radiation source (including where the owner or holder of the radiation source does not conduct related human activities);”.

4. Amendment of section 7 of Principal Act

4. Section 7 of the Principal Act is amended—

(a) in subsection (1)—

(i) in paragraph (d), by the substitution of “the carrying out of any relevant activity regardless of the location of the radiation source concerned” for “the transport, use, storage, maintenance and disposal of radioactive substances, nuclear devices or irradiating apparatus wheresoever located”,

(ii) in paragraph (f), by the substitution of “radiation sources” for “radioactive substances, nuclear devices, irradiating apparatus”, and

(iii) in paragraph (h), by the substitution of “radiation sources” for “radioactive substances, nuclear devices, irradiating apparatus”,

(b) in subsection (2)—

(i) by the substitution of “The functions of the Agency in relation to” for “Without prejudice to the European Communities (Ionising Radiation) Regulations 1991 (S.I. No. 43 of 1991), the functions of the Institute, in relation to”,

(ii) by the substitution of “radiation source” for “radioactive substance, nuclear device or irradiating apparatus” in each place that it occurs, and

(iii) by the substitution of “radiation source” for “substance, device or apparatus” in each place that it occurs,

(c) in subsection (4), by the substitution of “The Agency may carry out a relevant activity for any purpose in connection with a function conferred on the Agency” for “The Institute may have custody of, produce, process, handle, hold, store, use, manufacture, import, distribute, transport, export or otherwise dispose of radioactive substances, nuclear devices or irradiating apparatus for any purpose in connection with a function conferred on the Institute”,

(d) by the substitution of the following subsection for subsection (5):

“(5) The Agency shall not be required to be a registered person or licensee to carry out a relevant activity for any purpose in connection with a function specified in subsection (4).”,

and

(e) in subsection (6), by the substitution of “Any relevant activity carried out by the Agency before the 30th day of July 2014” for “Any custody, production, processing, handling, storing, using, manufacture, import, distribution, transport, export or disposal by the Institute, prior to the commencement of section 45 of the Radiological Protection (Miscellaneous Provisions) Act 2014, of radioactive substances, nuclear devices or irradiating apparatus”.

5. Amendment of section 8 of Principal Act

5. Section 8 of the Principal Act is amended—

(a) in paragraph (f), by the substitution of “radiological safety or radiation sources” for “radiological safety, radioactive substances, nuclear devices or irradiating apparatus”,

(b) in paragraph (g), by the substitution of “radiation sources” for “radioactive substances, nuclear devices or irradiating apparatus”,

(c) by the substitution of the following paragraph for paragraph (j):

“(j) to operate a licensing system and a registration system in respect of the carrying out of relevant activities;”,

(d) by the substitution of the following paragraph for paragraph (k):

“(k) to provide and, where appropriate, approve of, training in relation to relevant activities and in relation to radiological safety;”,

(e) in paragraph (l), by the substitution of “radiation sources” for “radioactive substances, nuclear devices, irradiating apparatus”, and

(f) in paragraph (m), by the substitution of “radiation sources” for “radioactive substances, nuclear devices, irradiating apparatus”.

6. Amendment of section 9 of Principal Act

6. Section 9 of the Principal Act is amended—

(a) in subsection (1)(a)—

(i) by the substitution of “the Agency may for the time being provide or carry on” for “the Institute is authorised for the time being to provide or carry on”,

(ii) by the substitution of “European act” for “directive, regulation or other act adopted by an institution of the European Communities”, and

(iii) by the substitution of “radiation sources” for “radioactive substances, nuclear devices, irradiating apparatus”,

(b) in subsection (2)—

(i) in paragraph (a), by the substitution of “radiation sources” for “radioactive substances, nuclear devices or irradiating apparatus”, and

(ii) in paragraph (b), by the substitution of “carrying out of a relevant activity in relation to such radiation sources as may be specified in the order” for “custody, use, manufacture, importation, distribution, transportation, insurance, sale, exportation or other disposal of radioactive substances or irradiating apparatus or nuclear devices as may be specified in the order”,

and

(c) by the substitution of the following subsection for subsection (3):

“(3) Before making an order under this section, the Minister shall consult with the Minister for Public Expenditure and Reform and such other (if any) Minister of the Government as the Minister considers appropriate having regard to the functions of that other Minister of the Government.”.

7. Amendment of section 29 of Principal Act

7. Section 29 of the Principal Act is amended—

(a) in subsection (1)—

(i) in paragraph (a)—

(I) by the substitution of “radiation sources” for “radioactive substances, nuclear devices, irradiating apparatus”, and

(II) by the substitution of “radiation sources,” for “radioactive substances, nuclear devices or irradiating apparatus,”,

(ii) in paragraph (b)—

(I) by the substitution of “any relevant activities relating to such radiation sources” for “any activities relating to such substances, devices, apparatus”, and

(II) by the substitution of “relating to such relevant activities” for “relating to such activities”,

and

(iii) in paragraph (e), by the substitution of “radiation source” for “radioactive substance, nuclear device or irradiating apparatus”,

and

(b) in subsection (2)—

(i) by the substitution of “radiation source” for “radioactive substance, nuclear device or irradiating apparatus” in each place that it occurs,

(ii) in paragraph (b), by the substitution of “radiation source” for “substance, device or apparatus”, and

(iii) in paragraph (c), by the substitution of “radiation source” for “substance, device or apparatus”.

8. Registration or licensing by Agency

8. The Principal Act is amended by the insertion of the following section after section 29:

“29A. (1) (a) A person who wishes to carry out a relevant activity which, pursuant to regulations made under section 30(1) or (2), requires authorisation and who is required by those regulations to be a registered person or a licensee in respect of the relevant activity, shall make an application, in accordance with regulations made under section 30(7), for authorisation in respect of the relevant activity before carrying out that relevant activity.

(b) A person who wishes to renew a licence in respect of a relevant activity which, pursuant to regulations made under section 30(1) or (2), requires authorisation and who is required by those regulations to be a registered person or a licensee in respect of the relevant activity, shall make an application, before the expiration of the licence and in accordance with regulations made under section 30(7) in that regard, for the renewal of the licence.

(2) (a) Subject to paragraph (b), where the Agency receives an application referred to in subsection (1), the Agency shall decide, based on its regulatory experience and taking into account—

(i) the magnitude of expected or potential doses of radiation, and

(ii) the complexity of the relevant activity to which the application relates,

whether it is registration or a licence which would be appropriate to be granted in respect of the relevant activity concerned.

(b) The Minister may, in regulations made under section 30(1) or (2), provide in respect of a relevant activity that only a licence may be granted and, where provision is so made, the Agency shall, where it receives an application referred to in subsection (1) in respect of the relevant activity, consider the application on the basis that only a licence would be appropriate to be granted in respect of that relevant activity.

(3) (a) Where, having considered an application, the Agency decides to grant registration or a licence, as the case may be, the Agency may, in accordance with section 30(4)—

(i) attach conditions to the registration so granted, or

(ii) specify conditions in the licence so granted.

(b) In the case of an application for the renewal of a licence referred to in subsection (1)(b), conditions which the Agency may attach to a registration or specify in a licence which the Agency decides to grant in respect of that application may or may not be the same as the conditions (if any) specified in the licence which is due to expire.

(4) Where registration is granted by the Agency, the following shall apply:

(a) the Agency may carry out inspections under section 29 in relation to the carrying out of the relevant activity in respect of which the registration is granted;

(b) the registration shall not be required to be renewed.

(5) Where a licence is granted by the Agency, the following shall apply:

(a) the Agency may carry out inspections under section 29 in relation to the carrying out of the relevant activity in respect of which the licence is granted;

(b) the licence shall be required to be renewed periodically.”.

9. Register

9. The Principal Act is amended by the insertion of the following section after section 29A (inserted by section 8):

“29B. (1) The Agency shall, in relation to relevant activities registered or licensed by it, establish and maintain—

(a) a register of registered relevant activities, and

(b) a register of licensed relevant activities.

(2) Where the Agency grants registration or a licence, it shall enter in the appropriate register referred to in subsection (1) particulars of—

(a) the relevant activity registered or licensed, as the case may be,

(b) the registered person or licensee, as the case may be,

(c) the purpose for which the relevant activity has been registered or licensed,

(d) any conditions attached by the Agency to the registration or specified in the licence, and

(e) such other particulars as the Agency considers appropriate.

(3) A relevant activity in respect of which registration or a licence is granted may be carried out in accordance with the registration or licence, as the case may be, from the date on which the particulars referred to in subsection (2) are entered in the register of registered relevant activities or the register of registered licensed activities, as appropriate.”.

10. Amendment of section 30 of Principal Act

10. (1) Section 30 of the Principal Act is amended by—

(a) the substitution of the following subsection for subsection (1):

“(1) The Minister may by regulations provide for the carrying out of relevant activities and for interventions that may be required to deal with ionising radiation of natural, terrestrial or cosmic origin.”,

(b) the substitution of the following subsection for subsection (2):

“(2) The Minister may make regulations for the purpose of giving effect to a European act which relates to relevant activities or the protection of the health of individuals who are subject to occupational or public exposures against the dangers arising from ionising radiation.”,

(c) the insertion of the following subsection after subsection (2):