Working with ionising radiation. Ionising Radiations Regulations 2017. Approved Code of Practice and guidance

Health and Safety Executive

Ionising Radiations Regulations 2017

Approved Code of Practice and guidance

This Approved Code of Practice and guidance will help employers comply with their duties under the Ionising Radiations Regulations 2017, which came into force on 1 January 2018.

The publication is also relevant to employees who work with ionising radiation, radiation protection advisers, radiation protection supervisors, and general health and safety officers. It can also be used by self-employed people who work with ionising radiation and have certain duties under these Regulations, both as an employer and as an employee.

Main changes since the last edition (IRR99)

■■ The dose limit for exposure to the lens of the eye has been reduced from 150 mSv to 20 mSv in a year. L121 (Second edition) ■■ There is a new system of authorisation for work with ionising radiation – the Published 2018 higher the radiation protection risk, the greater the requirements. A three-tier system of regulatory control, notification, registration and consent has replaced the previous requirement for notification and prior authorisation. To notify, register or get consent from HSE, go to https://services.hse.gov.uk/bssd/ ■■ The requirement for notification has been changed to a lower level of activity than in IRR99. ■■ The definition of an outside worker has been broadened so that it includes both classified and non-classified workers. ■■ There is now a requirement to put procedures in place to estimate doses to members of the public. ■■ Guidance has been clarified regarding the duties of employees to co-operate with employers in meeting the requirements of these Regulations. ■■ Medical appeals by an employee are made to HSE within 28 days of the employee being notified of the appointed doctor’s decision. This has been introduced for consistency with other regulations.

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Published with the permission of the Health and Safety Executive on behalf of the Controller of Her Majesty’s Stationery Office.

© Crown copyright 2018

First published 2000 Second edition 2018

ISBN 978 0 7176 6662 1

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Approved Code of Practice This Code has been approved by the Health and Safety Executive, with the consent of the Secretary of State. It gives practical advice on how to comply with the law. If you follow the advice you will be doing enough to comply with the law in respect of those specific matters on which the Code gives advice. You may use alternative methods to those set out in the Code in order to comply with the law.

However, the Code has a special legal status. If you are prosecuted for breach of health and safety law, and it is proved that you did not follow the relevant provisions of the Code, you will need to show that you have complied with the law in some other way or a Court will find you at fault.

Guidance The Regulations and Approved Code of Practice (ACOP) are accompanied by guidance. Following the guidance is not compulsory and you are free to take other action. But if you do follow the guidance you will normally be doing enough to comply with the law. Health and safety inspectors seek to secure compliance with the law and may refer to this guidance as illustrating good practice.

Presentation The ACOP text is set out in bold, the accompanying guidance is in normal type, and the text of the Regulations is in italics. Coloured borders also indicate each section clearly.

Contents

Introduction 7 PART 1 Preliminary 10 Regulation 1 Citation and commencement 10 Regulation 2 Interpretation 10 Regulation 3 Application 17 Regulation 4 Duties under the Regulations 18 PART 2 General principles and procedures 19 Regulation 5 Notification of certain work 19 Regulation 6 Registration of certain practices 23 Regulation 7 Consent to carry out specified practices 25 Regulation 8 Radiation risk assessments 27 Regulation 9 Restriction of exposure 32 Regulation 10 Personal protective equipment 47 Regulation 11 Maintenance and examination of engineering controls etc and personal protective equipment 47 Regulation 12 Dose limitation 50 Regulation 13 Contingency plans 55 PART 3 Arrangements for the management of radiation protection 59 Regulation 14 Radiation protection adviser 59 Regulation 15 Information, instruction and training 61 Regulation 16 Co-operation between employers 64 PART 4 Designated areas 67 Regulation 17 Designation of controlled or supervised areas 67 Regulation 18 Local rules and radiation protection supervisors 72 Regulation 19 Additional requirements for designated areas 76 Regulation 20 Monitoring of designated areas 85

PART 5 Classification and monitoring of persons 90 Regulation 21 Designation of classified persons 90 Regulation 22 Dose assessment and recording 92 Regulation 23 Estimated and notional doses and special entries 100 Regulation 24 Dosimetry for accidents etc 105 Regulation 25 Medical surveillance 106 Regulation 26 Investigation and notification of overexposure 111 Regulation 27 Dose limitation for overexposed employees 113 PART 6 Arrangements for the control of radioactive substances, articles and equipment 115 Regulation 28 Sealed sources and articles containing or embodying radioactive substances 115 Regulation 29 Accounting for radioactive substances 117 Regulation 30 Keeping and moving of radioactive substances 119 Regulation 31 Notification of certain occurrences 121 Regulation 32 Duties of manufacturers etc of articles for use in work with ionising radiation 123 Regulation 34 Misuse of or interference with sources of ionising radiation 125 PART 7 Duties of employees and miscellaneous 126 Regulation 35 Duties of employees 126 Regulation 36 Approval of dosimetry services 127 Regulation 37 Defence on contravention 128 Regulation 38 Exemption certificates 129 Regulation 39 Extension outside Great Britain 130 Regulation 40 Modifications relating to the Ministry of Defence etc 130 Regulation 41 Transitional provisions and savings 132 Regulation 42 Modifications and revocation 132 Regulation 43 Review 132

SCHEDULES 133 Schedule 1 Work not required to be notified under regulation 5 133 Schedule 2 Consent to carry out a practice: indicative list of information 135 Schedule 3 Dose limits 136 Schedule 4 Matters in respect of which a radiation protection adviser must be consulted 139 Schedule 5 Particulars to be entered in the radiation passbook 140 Schedule 6 Particulars to be contained in a health record 141 Schedule 7 Quantities and concentrations of radionuclides 142 Schedule 8 Transitional provisions and savings 159 Schedule 9 Modifications 161 APPENDIX 1 Notice of approval 166 APPENDIX 2 Estimating effective dose and equivalent dose from external radiation 167 APPENDIX 3 Abbreviations 170 References 171 Further information 173

Introduction

1 The Ionising Radiations Regulations 2017 (IRR17) set out your minimum legal duties and the Approved Code of Practice (ACOP) text and guidance within this publication give practical advice on how to comply with those Regulations. The format of this publication is designed to clearly distinguish between the Regulations, the ACOP and the guidance.

2 This publication is intended for use by employers, but it is also relevant to employees and contractors who work with ionising radiation, radiation protection advisers and radiation protection supervisors, as well as general health and safety officers. It can also be used by self-employed people who work with ionising radiation and have certain duties under these Regulations both as an employer and as an employee.

3 The ACOP text, Regulations and guidance reflect the requirements of the Ionising Radiations Regulations 20171 which implement the Basic Safety Standards Directive 2013/59/Euratom2 in Great Britain (Northern Ireland publishes separate regulations). The IRR17 came into force on 1 January 2018 and they replaced the Ionising Radiations Regulations 1999 (IRR99).

4 On 6 February 2018, the IRR17 were amended by the Ionising Radiation (Medical Exposure) Regulations 2017 (IRMER17). The main amendment was to remove regulation 33 (equipment used for medical exposure) from IRR17, as provision for medical equipment has now been included in IRMER17. This ACOP text, Regulations and guidance reflect the IRR17 as amended by IRMER17.

The Basic Safety Standards Directive 5 The 2013 Basic Safety Standards Directive (referred to as BSSD within this publication) brings five directives and an EU commission recommendation into one Directive:

■■ Basic Safety Standards Directive 96/29/Euratom; ■■ Medical Exposures Directive 97/43/Euratom; ■■ Outside Workers Directive 90/641/Euratom; ■■ Control of high-activity sealed radioactive sources and orphan sources 2003/122/Euratom; ■■ Public Information Directive 89/618/Euratom; ■■ Radon Commission Recommendation 90/143/Euratom.

6 The BSSD lays down requirements for protection against the dangers arising from exposure to ionising radiation. The aims of the Directive are to make sure:

■■ minimum standards for protection against ionising radiation are introduced across all member states; ■■ dutyholders minimise, so far as is reasonably practicable, the risks from ionising radiation to which workers, the public and others may be exposed; ■■ risks from ionising radiation are controlled.

Scope of the revised Regulations 7 Regulation 3 of IRR17 sets out the scope of application of the Regulations. They apply to:

■■ any practice as defined in regulation 2(1) including work with materials containing naturally occurring radionuclides; ■■ any work (other than a practice) carried on in an atmosphere containing radon 222 gas at an annual average activity concentration in air exceeding 300 Bq m-3.

8 Regulation 3 also sets out provisions that do not apply to people undergoing medical exposures. Such exposures are regulated by the Department of Health and Social Care and the Devolved Administrations.

Self-employed people 9 Regulation 2(2) extends references to the terms employer and employee, in certain circumstances, to include self-employed people. For example, self- employed people may be required to:

■■ carry out an assessment under regulation 8; ■■ provide control measures to restrict exposures under regulation 9; ■■ arrange for their own training under regulation 15; ■■ designate themselves as classified persons under regulation 21; ■■ make arrangements with an approved dosimetry service (ADS) for assessment and recording of their doses under regulation 22; ■■ obtain and keep a radiation passbook up to date if they are an outside worker; ■■ make sure that they use a dosemeter provided by an ADS as in regulation 35.

10 Although only the courts can give an authoritative interpretation of law, in considering the application of these Regulations, ACOP and guidance to people working under another’s direction, the following should be considered:

■■ if people working under the control and direction of others are treated as self- employed for tax and national insurance purposes they may still be treated as their employees for health and safety purposes. It may therefore be necessary to take appropriate action to protect them; ■■ if any doubt exists about who is responsible for the health and safety of a worker this could be clarified and included in the terms of a contract. However, remember that a legal duty under section 3 of the Health and Safety at Work etc Act 1974 (HSWA)3 cannot be passed on by means of a contract and there will still be duties towards others under section 3 of HSWA. If you employ such workers on the basis that they are responsible for their own health and safety, you should seek legal advice before doing so.

About this publication 11 This publication has been revised to take account of IRR17, as amended by IRMER17 (see paragraph 4 above). It sets out the Regulations, ACOP and associated guidance. It forms a framework which, if followed, makes sure exposure to ionising radiation arising from work activities is kept as low as reasonably practicable and does not exceed the dose limits specified within the Regulations.

12 The changes, which are summarised below, have been widely consulted on. They include:

■■ lowering the dose limit to the lens of the eye; ■■ flexibility for five-year averaging for dose limit to lens of the eye, subject to conditions specified by HSE; ■■ change to the radon reference level. The IRR99 radon reference level was over a 24-hour period, while BSSD expresses the reference level on an annual basis. Calculations show that the IRR99 reference level is broadly equivalent to the annual average reference level in IRR17; ■■ introducing a three-tier system of notification, registration and consent that replaces the IRR99 requirement for notification and prior authorisation; ■■ change to the requirement for notification, which for some radionuclides is at a lower threshold than in IRR99; ■■ broadening the scope of the definition of an outside worker so that it includes both classified and non-classified workers; ■■ change to the dose record retention period from 50 years to not less than 30 years after the last day of work; ■■ a requirement to put procedures in place to estimate doses to members of the public; ■■ a change to remove the requirement for a registered medical practitioner to be appointed ‘in writing’ for the purposes of these Regulations; ■■ introducing a requirement for authorisation of the annual whole-body dose limit in special cases – HSE or Office for Nuclear Regulation (ONR) may authorise the application of an effective dose limit of 100 mSv over five years (with no more than 50 mSv in a single year) rather than dutyholders only giving prior notification; ■■ recording and analysis of significant events, ie radiation accidents; ■■ removing the subsidiary dose limit for the abdomen of a woman of reproductive capacity; ■■ removing references to ‘radiation employers’, a term that has previously caused confusion, and replacing it where appropriate, with reference to an employer who works with ionising radiation; ■■ those required to accommodate other legislative, standard or guidance changes.

About ACOPs 13 Approved Codes of Practice are approved by the HSE Board with the consent of the Secretary of State (see Appendix 1: Notice of Approval for details).

14 The ACOP paragraphs describe preferred or recommended methods that can be used (or standards to be met) to comply with the Regulations and the duties imposed by the HSWA. The accompanying guidance also provides advice on achieving compliance, or it may give information of a general nature, including explanation of the requirements of the law, more specific technical information or references to further sources of information.

15 The legal status of ACOP and guidance text is given on the copyright page.

PART 1 Preliminary

Regulation 1 Citation and commencement Regulation 1 (1) These Regulations may be cited as the Ionising Radiations Regulations 2017.

(2) They come into force on 1st January 2018.

Regulation 2 Interpretation Regulation 2(1) (1) In these Regulations –

“the 1974 Act” means the Health and Safety at Work etc. Act 1974;

“accelerator” means an apparatus or installation in which particles are accelerated and which emits ionising radiation with an energy higher than 1 MeV;

“appointed doctor” means a registered medical practitioner who meets such recognition criteria as may from time to time be specified in writing by the Executive;

“approved” means approved for the time being in writing for the purposes of these Regulations by the Executive or the ONR (as the case may be) and published in such form as that body considers appropriate;

“approved dosimetry service” means a dosimetry service approved in accordance with regulation 36;

“authorised defence site” has the meaning given by regulation 2(1) of the Health and Safety (Enforcing Authority) Regulations 1998;

“calendar year” means a period of 12 months beginning with the 1st January;

“classified outside worker” means a classified person who carries out services in the controlled area of any employer (other than the controlled area of their own employer);

“classified person” means –

(a) a person designated as such pursuant to regulation 21(1); and (b) in the case of a classified outside worker employed by an undertaking in Northern Ireland or in another member State, a person who has been designated as a Category A exposed worker within the meaning of Article 40 of the Directive;

“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;

“contamination” means the unintended or undesirable presence of radioactive Regulation 2(1) substances on surfaces or within solids, liquids or gases or on the human body, and “contaminated” is to be construed accordingly;

“controlled area” means –

(a) in the case of an area situated in Great Britain, an area which has been so designated in accordance with regulation 17(1); and (b) in the case of an area situated in Northern Ireland or in another member State, an area subject to special rules for the purposes of protection against ionising radiation and to which access is controlled as specified in Article 37 of the Directive;

“the Directive” means Council Directive 2013/59/ Euratom laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/ Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom;

“dose” means, in relation to ionising radiation, any dose quantity or sum of dose quantities mentioned in Schedule 3;

“dose assessment” means the dose assessment made and recorded by an approved dosimetry service in accordance with regulation 22;

“dose constraint” means a constraint set on the prospective doses of individuals which may result from a given radiation source;

“dose limit” means, in relation to persons of a specified class, the limit on effective dose or equivalent dose specified in Schedule 3 in relation to a person of that class;

“dose rate” means, in relation to a place, the rate at which a person or part of a person would