Comprehensive HSE Notification, Registration & Licensing Guide for Radiological Practices

1. HSE Graded Approach • Notification • Registration • Licensing • ……of a practice • Practice means a human activity that can increase the exposure of individuals to radiation from a radiation source and is managed as a planned exposure situation; • No transitional arrangements allowed - practices will have notify/register/licenceby early 2018

2. HSE Notification • Small quantities of radioactive material • Radon >300Bqm-3 • NORM • Similar to current arrangements – schedule 2 • Likely simple system • Digital/Electronic • Who, what, where • Estimated 20,000 dutyholders will have to notify – time taken around 15 minutes

3. Notification - requirements • Name and primary address of dutyholder • Which practice is being performed? • Whether the practice is to be performed at premises other than the primary address of the dutyholder • The fixed postal address(es) at which the practice will be/is carried out • Details of highest radiological risk in the workplace • Number of dutyholder employees • Number of dutyholder classified radiation employees • Highest recorded Radon concentration (where relevant)

4. HSE Registration • the operation of radiation generators or accelerators or radioactive sources for medical exposures or for non-medical imaging purposes • the operation of radiation generators or accelerators, except electron microscopes, or radioactive sources for purposes not covered by point (a). • This will cover the majority of practices – approximately 28,000 dutyholders • Each notifiable practice will require separate application

5. HSE Registration • Electronic system with small fee • Require submission of information/confirmation – on the basis of around 8-10 questions. • Give assurance to HSE that permission can be granted – determine risk profile to inform inspection

6. Registration: Indicative Questions • Confirmation that you have completed a risk assessment to identify the main radiological risks associated with your work and identified any reasonably foreseeable radiation accident ? • Confirmation that you have identified and completed actions that will restrict your employees’ and other persons exposure to ionising radiation to a level which is as low as reasonably practicable? • Confirmation that you have provided adequate training to those of your employees engaged in work with ionising radiation and those likely to be affected by that work?

7. Registration: Indicative Questions (2) • Confirmation that you have, where legally required, drawn up written local rules and appointed radiation protection supervisor(s)? • Confirmation that you have consulted an RPA as to the observance of the IRR18? TO NOTE: All of these are examples of possible questions discussed – do not take this as agreed as this is not an exhaustive list!!

8. HSE registration • Proposed renewal every 4 years • 30 minutes to prepare information and 10 minutes to complete form • No requirement to submit documents • Each registerable practice will require a separate registration

9. HSE Licensing Occupational exposure aspects of: • the deliberate administration of radioactive substances to persons and, in so far as the radiation protection of human beings is concerned, animals for the purpose of medical or veterinary diagnosis, treatment or research • the deliberate addition of radioactive substances in the production or manufacture of consumer products or other products, including medicinal products, and the import of such products • any practice involving a high-activity sealed source; • practices discharging significant amounts of radioactive material with airborne or liquid effluent into the environment

10. HSE Licensing • Electronic system with fee • To allow HSE to gain assurance that permission should be granted – and to determine risk profile of practice. Include information specified in Annex IX of BSSD • No requirement to submit documents • Around 1,200 dutyholders (2,400 practices) will fall under this. • Proposed renewal of licences every 4 years • 80 minutes to prepare/resesarch necessary information – 15 minutes to complete online form

11. Licensing: Indicative Questions • Confirmation that the overall management, planning, organising, controlling and reviewing of this radiation risk have been considered • Confirmation that they have appointed and consulted with a suitable radiation protection adviser (RPA) • Confirmation that those engaged in the practice have received appropriate training in radiological protection and will receive regular updates/refresher training in radiological protection

12. Licensing: indicative questions (2) • Confirmation that those engaged in the practice have been informed of the radiological risks to their health from the practice and the precautions that should be taken • Confirmation that those employees not engaged in work with ionising radiation but who are likely to be affected by it have received appropriate training in radiological protection. • Confirmation that the design features; engineering controls; and safety features of the facility and the radiation sources are such that exposures to radiation will be as low as reasonably practicable (ALARP)

13. Licensing: Indicative questions (3) • The maximum anticipated total annual effective dose( in mSv) and equivalent doses to eye, extremities and single organ or tissue, to an employee engaged in the practice • Confirmation that a maintenance, testing, inspection and servicing regime is in place which ensures that the radiation source and the facility continue to meet the design requirements, operational limits and conditions of operation throughout their lifetime • Confirmation that the management of any radioactive waste will ensure that exposures to employees will be ALARP TO NOTE: All of these are examples of possible questions discussed – do not take this as agreedas this is not an exhaustive list!!

14. Significant events • BSS requires recording and analysis of significant events • Significant events not defined • HSE will require (via alteration of Reg 12) record and analysis of events which trigger the use of contingency plans • Other reporting arrangements to HSE will remain the same.

15. Planned exposure • HSE consider that this is equivalent to the definition of work and practice that is captured in BSSD.

16. Dosimetry • Individual monitoring • Record retention • Weighting factors • Unique ID and nationality • Separate dose recording for accidents

17. Outside workers • Change in definition classified and non-classified workers and “performs activities” rather than “carries out services” • Drafting regulations now – trying to make OWs inclusive of regs

18. New Eye Dose Limit • From 150mSv to 20mSv per year with classification level at 15mSv • Recent research (PHE, NHS Trust) indicates most will be able to achieve this • Probable increase in the number of classified persons • Limited increase in costs due to current dosimetry arrangements • Greater demand for personal eye dosemeters • Discussed at eye dose subgroup • Applicability of calculation methods using collar badges or similar yet to be decided.

19. Implementation date • Government policy is not to implement European Directives early or late • Implementation early Feb 2018 • However: - Dose limits are annual - ADSs work in calendar years - Implementation part way through a year is expensive • Some aspects or all of IRR18 may come into force on 1st January 2018

20. Radon • Radon • Reference/notification level changes from 400Bqm-3 over any 24 hour period to 300 Bqm-3 annual average • In effect, no significant change • GB will need Radon National Action Plan • PHE lead • Notification required at or above this level.