Jurisdiction: Great Britain

Commencement: 1st October 2024

Amends: The Ionising Radiation (Medical Exposure) Regulations 2017


Mini Summary

The Ionising Radiation (Medical Exposure) Regulations 2017 apply to employers and those administering ionising radiation:
  • as part of their own medical diagnosis or treatment;
  • as part of research;
  • as asymptomatic individuals undergoing exposure for early diagnosis; and
  • as carers and comforters* of individuals undergoing medical exposure.

*Carers and comforters refer to individuals who knowingly and willingly support and comfort a person undergoing medical exposure (e.g. an x-ray), thereby incurring exposure to ionising radiation themselves. This does not include anyone comforting others as part of their occupation.


These Regulations revoke the Ionising Radiation (Medical Exposure) Regulations 2000.


Duties

Various duties apply and are available to view in full on the Legislation Update Service.


 

Amendment


Duties are updated that require employers and operators of ionising radiation equipment to:

  • co-operate with each other and share information; and
  • ensure each dose of ionising radiation is as low as reasonably practicable and consistent with the intended diagnostic or therapeutic purpose.

Additional changes:

  • update definitions, including expanding the meaning of ‘equipment’ to include software;
  • make corrections to cross-references due to omissions in The Ionising Radiation (Medical Exposure) (Amendment) Regulations 2018 (a previous update);
  • increase the fees for licences for employers;
  • amend training requirements for medical practitioners and operators; and
  • make minor technical amendments.

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Jurisdiction: Northern Ireland

Commencement: From 1st November 2020, these Regulations must be complied with in full.
Mini Summary
These Regulations transpose, in Northern Ireland, the emergency preparedness and response elements of Directive 2013/59/Euratom laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation (“Euratom Basic Safety Standards Directive”) for premises in which work with ionising radiation takes place.
Summary
The Euratom Basic Safety Standards Directive establishes the basic safety standards for the protection of the health of individuals subject to occupational, medical and public exposures against the dangers arising from ionising radiation.

The aim is that these Regulations will strengthen Northern Ireland’s emergency preparedness and response arrangements for radiological emergencies. It will also improve public protection and reduce adverse consequences in the event of an emergency.
Scope of the Regulations 
These Regulations apply to any work with ionising radiation which involves having on any premises, or providing for there to be on any premises, a radioactive substance containing more than the quantity specified in relation to that radionuclide in Schedule 1 or, in the case of fissile material*, more than the mass of that material specified in Schedule 2.

They do not apply where the operator can demonstrate that the quantity present on the premises would not allow, in a radiation emergency situation, an annual effective dose to persons off-site of greater than 1 millisievert* (mSv).

These Regulations do not apply in respect of;

*Fissile material is material that are composed of atoms that can be split by neutrons in a self-sustaining chain-reaction to release enormous amounts of energy.

*A millisievert is a unit of measurement for the effective dose of radiation absorbed by the body.

*A non-dispersible source means a sealed source or a radioactive substance that cannot cause a radiation emergency and does not include any radioactive substance that is or has been a component of a nuclear reactor.

* A substances activity is the concentration of something within the substance, based on its chemical potential.
Duties
Written Hazard Evaluations
Operators must carry out a written hazard evaluation before any work with ionising radiation is carried out for the first time.

Where the hazard evaluation reveals the potential for a radiation emergency to occur, the operator shall make an assessment in accordance with Schedule 3 to consider and evaluate a full range of possible consequences. The assessment must be completed within 2 months of the day the hazard evaluation is completed.

Further assessments are required to be made if the organisation makes a material change related to the ionising radiation process. In addition to this, if no changes to a radiation process have taken place in 3 years, an assessment is required within 3 years of the date of their last evaluation.

Consequences Reports

If an assessment is required following a hazard evaluation, in accordance with Schedule 3, the operator must also prepare a report setting out the consequences identified by that assessment, called a consequences report.

This must be done as soon as reasonably practicable on completion of the assessment and must include the information set out in Schedule 4. Operators must send this report to the Health and Safety Executive Northern Ireland (HSENI) before they start any work.

The operator must offer a meeting with the HSENI to discuss the consequences report and supply any information the HSENI may require in order to prepare an off-site emergency plan. The operator has 28 days in which to supply such information from the date of request.

Emergency Planning Zones
The HSENI must supply a detailed emergency planning zone (the area around a facility for which the HSENI must restrict public exposure in the event of a radiation emergency) to the operator on the basis of the operators recommendation within 2 months of having received the consequences report.

Confirmation of the HSEN’s detailed emergency planning zone must be recorded by the operator as finalised.
Emergency plans
Where it is determined by the operator that a risk of a radiation emergency is possible, the operator must define an adequate emergency plan to restrict the exposure to persons who may be affected as identified by the organisation. Regulation 10 further sets out the considerations, requirements, restrictions and other duties which must be taken into account when documenting the emergency plan.

Reviewing and testing of emergency plans

Emergency plans must be reviewed at least every 3 years, but if changes are made which affect the process then they must be reviewed at that stage. Operators must test their emergency plans to determine if they are effective. Reports of these tests must be documented within 3 months of the tests and supplied to the HSENI within 28 days of their completion.

There must be cooperation between the operator and the HSENI in order for emergency plans to be adequately tested.The HSENI may charge an operator a fee for the performance of its functions in relation to the off-site emergency plan.

Implementation of emergency plans

Operators must consult with any other employer who carries out work with ionising radiation on the premises, and take into account relevant matters arising from that consultation. Employers are required to cooperate with the operator or HSENI with regards to preparing an emergency plan, the exchange of information, and the testing of emergency plans as is necessary to ensure compliance with these Regulations.

An operator must put their emergency plan, or parts of it as necessary, into action without delay when a radiation emergency occurs or an event occurs which might lead to a radiation emergency. They must also inform the HSENI immediately. The HSENI will then implement any off-site emergency plans it has arranged, or parts of it as necessary.

The operator and HSENI must make a provisional assessment of the circumstances and consequences of the emergency and must consult:

The operator must make a full assessment of the effectiveness of the emergency plans with the cooperation of the HSENI. Within 28 days of the assessment the operator must make a report of the findings and keep the report for at least 50 years from the date the report was completed. The operator must supply the report to the HSENI within 28 days of its completion.

Emergency exposure of an employee
Where the emergency plan identifies the possibility of an employee receiving emergency exposure, the employer must:

An employee may be exposed to more than the approved dose in order to save a life, prevent severe health effects, or to prevent the development of catastrophic conditions, provided it is authorised by a duly responsible person, the employee has been informed about the risks involved and agrees to undergo the increased exposure.

After an emergency exposure the employer must assess the dose received by the employee, record it, and make this available to the employee. Reports made as a result of an emergency plan being initiated where an employee was exposed must be kept until that person reaches the age of 75, and for at least 30 years from the termination of the work which gave rise to the emergency exposure.

It should be noted that an employer has a duty under this section to any person who regularly provides a service as a volunteer.

Reference levels
Where the operator has prepared or the HSENI has arranged for the preparation of an emergency plan, it must ensure that the plan prioritises keeping effective doses below a 100 mSv (millisievert – the unit of measurement for the effective dose of radiation absorbed by the body) reference level. The dose level for each emergency worker must be recorded.

Where the response to a radiation emergency is underway, reference levels determined for emergency workers may be revised in order to optimise the response. In exceptional circumstances, a reference level for an effective dose for an emergency worker may be set in excess of 100 mSv but not exceeding 500 mSv.

Information to the public

The HSENI for an area covered by an off-site emergency plan with a detailed emergency planning zone must, in cooperation with the operator, ensure that members of the public are made aware of relevant information and, where appropriate, are provided with it.

In the event of an emergency, the HSENI has a duty to prepare, and keep up to date, arrangements to supply to the public with information about, and advice on, the facts of the emergency, the steps to be taken, and the protective action applicable.

Radiation protection adviser

All employers that do work with ionising radiation must consult one or more suitable radiation protection advisors about occupational and public exposure to assist that employer with preparations for responding to radiation emergency situations. Radiation protection advisors must be appointed in writing.

Transitional arrangements
Those who had a duty under The Radiation (Emergency Preparedness and Public Information) Regulations (Northern Ireland) 2001 may continue to comply with those Regulations until 31st October 2020.

Those who had a duty under The Ionising Radiations Regulations (Northern Ireland) 2017 may also continue complying with those Regulations until 31st October 2020.

From 1st November 2020, these Regulations must be complied with in full.

 

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