New UK Consent process for users of Ionising Radiation (as of February 2023)

New consent process (2023 -)

Broadly speaking the approach is the same for all three regulators identified above.

The process is as follows:

• The user (employer) will determine the relevant regulator (ONR, HSE and HSENI).
• Submit application online (via regulator online system).
• Submit a Safety Assessment (SA).
• The SA will be reviewed by the appropriate regulator inspector.
• The regulator will inspect the practice (this is a significant change compared to the current consent process).
• Consent will only be issued if the SA and site inspection are successful.
• Forget the £25 current application fee, future fees are likely to be in the £1000's.

It is understood (at the time of writing) that the SA will be submitted using an online portal and will consist of several parts, i.e. the SA is not a single document. Information will be submitted online using templates and forms, after successful completion of one template, the next will appear until all are completed. All completed templates / forms will then form the SA. It may be appropriate in certain circumstances to copy and paste the required information from an internal company document (risk assessment, work procedure, ALARP assessment etc) into the SA template. However employers will have to accept that despite having their own comprehensive set of documents, information has to be entered fresh into the new online portal. The only documents that can be submitted complete is the local rules and contingency arrangements (the upload is a requirement of the application process).

The basic submission and processing of the application is likely to be as follows:

• Employer chooses the appropriate category of consent (might be more than one).
• Provides required information that is common to all content types (see likely content required in later sections below).
• Completes the online SA templates and forms.
• Uploads local rules and contingency plans.
• Regulator reviews submission*
• Regulator undertakes site inspection of the practice**
• Employer pays the application fees
• Consent certificate issued to employer

The above simple process has a couple of hold points which could be problematic or even terminal if the application is not suitable and sufficient. There are two feedback loops in the assessment process that work as follows.

*Once submission is completed the safety assessment is reviewed by the appropriate specialist inspector. If the initial review is positive (successful) the assessment process continuous and a site inspection is arranged. If the initial review is unsuccessful the application is passed back to the employer with feedback and a request to resubmit. If a subsequent review still shows deficiencies the application is rejected completely. Fees still have to be paid for regulator work already completed.

** Following successful review of the safety assessment the regulator will conduct an initial site inspection. If the outcome of the initial inspection is positive (successful) then fees are paid and a consent certificate is issued. If the initial site inspection is unsuccessful the regulator will explain the deficiencies and ask the employer to correct them. If a subsequent inspection still shows deficiencies then the application is rejected completely with fees still requiring payment.

The employer is only allowed a second go at completing the application and passing a site inspection. It will be interesting to see if there is any flexibility, especially in the early days when the process will be new to both regulator and employer.

Interim consent

There may be circumstances where the employer cannot complete the safety assessment until the practice commences (for example certain dose rate measurements cannot be confirmed until a radiation source is on site). It is understood that an interim consent could be issued which would be converted to a full consent once the missing data was available.

Safety Assessment (SA) Content

This is a work in progress, but as noted above, a good risk assessment for compliance with IRR17 (8) is a good start.

At the time of writing it is understood that the 9 consent practices will eventually translated into 16 SA templates.

Helpfully, HSE, ONR and HSENI will all use the same templates.

Likely safety assessment information required for consent (applicable to all practices)

The following summary below is derived from an HSE document with draft status, so liable to change.

• Applicant name and, if different, the name of the employer’s legal entity.
• Company registered address.
• Contact details.
• Name, address and phone number of each fixed premises where the specified practice will be carried out*
• Total Number of employees (total number of all employees).
• Number of employees engaged in work with ionising radiation.
• Number of classified persons.
• The name of the employer’s Radiation Protection Adviser(s) (RPA)**
• Names, position and contact details of the person submitting the consent application***

* Note the subtle difference regarding name, address and phone number etc (as compared to current consent process). The regulator will require information for each fixed premises where the practice is carried out (currently it is only the details of the legal entity that is required). This is not the same as the old IRR99 requirement for notification at each premises. The idea is that one particular consent will cover all premises carrying out the relevant specified practice. There will obviously be some flexibility, since an employer who operates linear accelerators and conducts work at hospitals around the UK cannot list each (but they are 'fixed').

** Note that requiring the name of the RPA for consent is a new requirement.

***Note that this cannot be the RPA, unless the RPA is an employee of the employer making the consent application and has been authorised to do so.

Example safety assessment information required for a particular specified practice

A significant change in the consent process is that during the submission of safety assessment, questions will be asked which are specific to a particular practice. This is unlike the current consent process where all questions are more generic and apply to any specified practice.

The following example relates to industrial radiography and is a summary of the HSE draft offered to those attending the SRP meeting. We have only included the questions and not the guidance (we will post official guidance when available).

[Industrial Radiography is a very specific use of ionising radiation in the field of NDT (non destructive testing). Be sure you know what you are undertaking since the operation of an x-ray room for imaging of objects is not NDT and requires only a registration. The link in this paragraph will take you to an October 2023 blog on this very subject.]

• A general summary of the type of industrial radiography (enclosure and site) to be carried out and details of the premises at which the practice is performed.
• A summary of the arrangements for managing radiation protection during industrial radiography.
• Details of the frequency of use of the industrial radiography sources of radiation to be used, or likely to be used.
• Details of the nature of other sources of radiation in the working environment (e.g. radon exposures, occupational exposure from other sources of radiation not directly related to industrial radiography).
• Estimates of the radiation dose rates which employees and public can be exposed (e.g. maximum dose rates outside the radiographic controlled area, maximum dose rates possible resulting from radiation accidents, specific equivalent and effective whole body doses, annual exposure estimates).
• A summary of the engineering control measures and design features already in place, or planned, to comply with the requirements of IRR17 Regulation 9 (Restriction of Exposure).
• A summary of the maintenance and testing schedules for engineering controls, safety critical controls such as interlocks, warning devices and other safety features [Ionactive - sounds like a light version of EMIT (Examination, Maintenance, Inspection and Testing) used in the nuclear industry].
• A summary of, and results of, a Critical Examinations that will be or have been conducted in accordance with IRR17-32.
• Summary of the planned radiation dose rate monitoring regime for radiography areas and their surroundings including any areas to which the public may have access.
• Summary of the personal dosimetry to be used including types, wear periods, approved dosimetry services (includes active and passive dosimetry).
• The rationale for designating employees as Classified Persons.
• Summary of the radiological protection training that will be or has been provided to employees and other persons, including planned frequency and refresher training.
• Summary of the information supplied to employees concerning their work with ionising radiations in connection with pregnancy and breast feeding.
• A summary of possible radiation accident situations as identified in the radiation risk assessment, their likelihood and potential severity (including human failure, failure of systems of work, failure of engineering controls, interlocks, active warning signs).

You will note this is personalised for industrial radiography. Whilst it is likely there will some overlap of questions between the specified practices, the employer should expect to answer specific questions relating to their practice. Specific questions is no bad thing, and together with the guidance, should not be too arduous to complete.

Enforcement

Ultimately, revocation would require the cessation of the practice.

The regulator notes that existing enforcement methods remain available including:

• Notice of Contravention (NoC) - not on the public record.
• Improvement Notice - on the public record.
• Prohibition Notice - immediate cessation of work (i.e. the actions / conditions which lead to the notice being issued)

Notwithstanding the likely options outlined below, all cases could lead to prosecution by the regulator.

Employer does not have a consent, but conducts a specified practice

Whilst it is unlikely a UK employer would carry out a specified practice without a consent (since there would need to be multiplicative failures including not having a RPA), it could nevertheless happen. The approach adopted is likely to be:

• Determine if there is a serious risk of personal injury (this is defined sections 22 and 23 of the HSWA74). If YES, then a prohibition notice would be issued, followed by a Notice of Contravention (NoC) and instruction to cease the practice via a formal warning letter.
• If NO, then a decision depends on if the practice is carried out in the medical sector. If NO, the practice is not carried out in the medical sector, then the route is NoC and instruction to cease the practice via a formal warning letter.
• If the practice is carried out in the medical sector (i.e. YES), then the decision process depends on the likelihood of detriment to patient diagnosis or treatment. If patient diagnosis or treatment is likely to be compromised then the regulator may issue an interim consent. If patient diagnosis or treatment is not likely to be compromised then the route is NoC and instruction to cease the practice via a formal warning letter.

Employer not conducting the practice in accordance with a safety assessment

This would include situations where there are radiation accidents / incidents or general poor compliance with the safety assessment (and / or systems and procedures derived from the assessment).

Ultimately it is for the regulator to decide what action to take, and this will likely be proportional to the nature and significance of the breach. Options could include:

• Revoke the consent.
• Suspend the consent.
• Provide a notification that the consent will be revoked unless improvement actions are taken to the satisfaction of the regulator, and within the time frame permitted.
• For minor breaches, a warning letter may be issued but no enforcement action required.

New (August 2023). If you have read all you need about consents, then head over to the latest Ionactive blog article on registrations, yes they are changing too!

New UK Registration process for users of Ionising Radiation (as of August 2023).