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Ionising Radiations Regulations 2017

15 December 2017 - Ionising Radiations Regulations 2017 (what you need to know right now)

Ionactive has produced this summary guidance note for the new Ionising Radiations Regulations 2017 (IRR17) which becomes law on 1 January 2018. Despite the impending regulation change, one of the most significant changes noted below does not have to be in place before 6 February 2018. Despite what you may have read or heard elsewhere, the new IRR17 is not a radical departure from the requirements of IRR99. Radiation protection is a mature area of health and safety, and despite continued research by ICRP and others, the fundamentals remain the same.

New notification process (comply by 6th February 2018)

The most significant change requires ionising radiation users (‘radiation employers’ under IRR99, ‘employers’ under IRR17) to re-notify their work with HSE (Health and Safety Executive). Under IRR99 new users were required to make a ‘28 day notification’ – this only required the provision of basic information (e.g. contact name, address etc) and source type (e.g. x-ray, closed source, open source, accelerator and radon). Overall this information was not that useful to HSE and provided no information regarding the relative risk of one user over another. For example, one user using a 60kV x-ray machine for quality control in the food industry, and another user using a 300 kV x-ray for enclosure industrial radiography, would not be distinguishable from each other – despite different exposure potentials. Driven by this need to be able to discern risk (for more targeted inspection?), and the requirements of the 2013 Euratom Basic Safety Standards Directive (2013/59/EURATOM), has lead to a new risk based HSE notification. Unfortunately, HSE preparation for this process, including provision of a new application website, has been somewhat biased towards the end of 2017. Therefore, whilst some preparation for the new notification process can take place now, the actual application will not be possible before sometime in the first week of January 2018.

Notification, Registration or Consent (which is for you?)

It is important to note that under the new system, all current users of ionising radiation will need to complete an application for either a ‘Notification’, a ‘Registration’ or a ‘Consent’ by 6 February 2018. For current users the application process does not yield a ‘permission’ to work with ionising radiation – in other words, as long as the online application form is completed correctly (i.e. no missing information / no blank spaces etc), then you are complying with IRR17. Of course, the onus is on the user to provide the correct and compliant information – the expectation being that the HSE could then choose to visit a user and test compliance in the workplace against the provided application information. Notwithstanding this, subject to the other small changes in IRR17 (noted below), if you have been complying with IRR99 up to now, and have all the required documents and records in place, then there should be no issue with IRR17 compliance. It is prudent therefore to conduct a timely review of IRR99 / IRR17 compliance ahead of completing the application process.

Do you have to notify HSE? What about Schedule 1 'exemptions'?

Like IRR99, IRR17 does make provision for certain types of work that do not need to be notified (Schedule 1). However, also like IRR99, IRR17 provides limited scope for this for some types of users / equipment. For example, x-ray equipment that meets very low dose rate criteria (i.e. < 1 micro Sv/h at 10 cm from any surface) and is Type Approved by HSE will not be notifiable. Unfortunately, HSE type approved zero x-ray units during the reign of IRR99 and we see no difference for IRR17. So typical x-ray units used in security, food quality assurance screening and similar will still come under the new notification system (‘registration’).

Notify

For the lowest level of risk under the new notification system there is ‘notify’ and it is quite limited in scope – basically for bulk quantities of low activity artificial or naturally occurring radioactive material, and also working in a radon atmosphere above an annual average of 300 Bq per cubic meter of air.

Register

The vast number of users will fall into the medium risk category of ‘registration’. Examples include radiation generators in the kV range (security, quality assurance, process control, diagnostic medical equipment and similar). Also included in this category would be typical users of low to medium activity unsealed radioactive material (e.g. in biomedical research, university research and similar). Similarly, users of sealed radioactive sources which are not HASS level sources, would also be included in this category. Users of HASS sources, and those who work with unsealed radioactive materials designed to be introduced into people or animals for medical purposes would not be included in the registration category. In addition, industrial radiography using x-ray systems would be treated under the consent regime (unless its in an enclosure not designed to be entered at any time).

Consent

A still substantial group of users will fall into the high-risk category of ‘consent’. Consent is required for ‘specified practices’ which include the deliberate administration of radioactive substances into people and animals for medical purposes, operation of accelerators (typically those for radiotherapy, security, production of radioisotopes), industrial radiography, industrial irradiation, users of HASS sources (not included in industrial radiography or irradiation) and the larger users of unsealed radioactive materials with significant discharge permits to air or aqueous routes into the environment.

Your Radiation Protection Adviser (RPA) should assist you in selecting the correct category for your work and then making the application.  Information on the HSE website is also useful and the following resources are recommended:

Link: HSE Notification Process (HSE website)

Link: Ionising Radiations Regulations 2017 & ACoP (PDF)  

Link: HSE expected questions for notify, register and consent (PDF)

Link: Ionising Radiations Regulations 2017 (2017: No. 1075)

Risk assessment - the hub of everything you need to do with IRR17

Before providing a brief summary of the other main changes in IRR17 – it is appropriate to provide a reminder of the importance of risk assessment (Regulation 8 under IRR17, formally Regulation 7 under IRR99). The risk assessment is the hub for the entire set of regulation – its output will determine the requirements for dosimetry, monitoring, training, designated areas, classified persons – indeed everything in IRR17. Whilst you should already have one in place (i.e. current user), the new notification process is an ideal opportunity to review the assessment and ensure you have everything in order. You cannot go far wrong if you review the ACoP paragraphs of 70 and 71 in the new IRR17. Our advice is that you make a positive statement against each of the items in the two paragraphs to ensure you have considered everything. As we say to many of our clients, proving the negative is as important as evaluating the positive.

Other changes to note


The other main changes are outlined below (paragraph 12 in the revised IRR17 ACoP provides the complete list):

Regulation numbering: a rather unfortunate consequence of inserting a new regulation early on in IRR17 is that all further regulations are now advanced by one compared with IRR99 – so risk assessment (IRR99-7) becomes (IRR17-8), restriction of exposure (IRR99-8) becomes (IRR17-9), radiation protection adviser (IRR99-13) becomes (IRR17-14) and so on. Perhaps not a huge deal for many, but those who quote regulation numbers in their compliance documents or training material have quite a heavy editing job on their hands.

Notification and recording of significant events (IRR17-13-contingency): has been made more robust as compared to IRR99. For example, it now requires that where a contingency plan is put into effect, then you should analyse the cause of the accident, take steps to prevent reoccurrence, record your findings and keep records of this for at least two years, and record any accidental exposures on the dose record. There is also an ACoP requirement to demonstrate that the plan has been practiced by those that will need to implement it (i.e. formal training required with appropriate records).

Lens of the eye dose limit
:  being reduced from 150mSv / year to 20 mSv/year. Classified worker status required where 15mSv eye dose is likely to be reached. All other dose limits stay the same as IRR99 although the record keeping requirements have changed such that classified worker records should be retained until the person subject to the record is 75, but in any case, should be retained for at least 30 years.

Subsidiary dose limit to abdomen of women of reproductive capacity: this requirement (13mSv equivalent dose in any 3 month period) is removed. It has been effectively redundant for years as doses to female (and indeed all workers) has steadily reduced. In addition, the dosimetry assessment distinguishing the effective dose to the trunk of the body vs the equivalent dose to the abdomen has always been challenging. This does not represent a lowering of safety standards – for most of our clients we work on a dose constraint of 1mSv/year (male or female) which deals with this now redundant limit and the limit to the developing baby once pregnancy is declared (1mSv for duration of pregnancy after declaration).

Employer and Radiation Employer: IRR17 removes the distinction between the two (Radiation Employer definition is removed). The HSE cite confusion as a reason for making the change. Basically, under IRR99 the employer had certain duties under IRR99 (e.g. control access to designated areas), whereas the radiation employer had full duties under IRR99. This could be used where for example a factory (not working with ionising radiation) needed to employ a contractor to undertake industrial radiography of a boiler (working with ionising radiation). Whilst the radiography contractor would set up their area, demarcate it and apply local rules, the employer (factory) still had a duty (to assist) in controlling access to their contractor designated area. With IRR17 the interaction between the two (and duty under IRR17) would be assessed on a case by case basis with cooperation between employers and advice from the RPA.

Non-classified outside workers: Under IRR99 an outside worker was a classified employee from one employer, who works in the designated area of another employer. To enter that area the outside worker would need to supply passbook and show evidence of suitably training etc. Under IRR17 a new class known as ‘non-classified outside worker’ is introduced. We believe this has been partly introduced because there is a clear trend towards lower annual exposures and not classifying workers. We have some evidence that under the IRR99 regulations it was often easier to get a non-classified person into a designated area of another employer, compared with a classified radiation worker (outside). This new designation requires that the employer of the non-classified outside worker ensure they have specific training in the nature and activities of the controlled area (e.g. PPE), have systems in place to ensure that > 6mSv/year whole body effective dose (or 3/10 of any other dose limit) cannot be received due to work carried out in the other employers designated area. This will require efficient cooperation between employers.

Instantaneous Dose Rate (IDR):  IDR has probably created more consultation input than any other part of IRR17.  The impact of any IDR limit (or other restriction) is practice specific. For example, it is common in the medical sector that radiotherapy bunker design is based on time average dose rates. It can be shown absolutely (assuming the bunker design is adequate) that the dose received in an hour (micro-Sv-in-any-one-hour) is a small fraction of the apparent exposure when based on IDR alone. This is a function of duration of exposure, direction of exposure, occupancy in the area, treatment workload etc. Many RPAs will strongly argue that shielding that attenuates IDR only (as opposed to being calculated from the time average dose limit) leads to a non-ALARP level of protection, where money could be better spent on other areas of health and safety.

In IRR17, the requirement for designating a controlled area (for external whole-body exposure) is where the dose rate exceeds 7.5 micro Sv/h when averaged over a working day (so time averaging is allowed), with the proviso that a controlled area be established if the IDR exceeds 100 micro Sv/h (regardless of time averaging). It is important to note in the guidance (para 309 of IRR17 ACoP) that for open site industrial radiography, there is a requirement to designate a controlled area where the dose rate exceeds 7.5 micro Sv/h when averaged over one minute.

Are you ready for IRR17?

We have already been assisting our higher risk clients (consent level under IRR17) to prepare for consent applications, despite the regulations recently still being in draft and with no final set of questions (see Question Set link). We will be contacting all other clients during January 2018 to ensure that everything is in place to make their applications (most of which will be ‘registrations’).  In summary, if you are already doing all you should under IRR99, then subject to some specific changes for a small sub-set of employees (e.g. new eye dose limits), there is little in IRR17 that need worry any current or new user of ionising radiation.

Mark Ramsay
Radiation Protection Adviser
Radioactive Waste Adviser

(Released 15 December 2017)

Article Source:

Ionactive Consulting Limited - December 2017


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