Legislation Update Ireland: New Ionising Radiation Regulations 2019

Legislation Update

The Radiological Protection Act 1991 (Ionising Radiation) Regulations 2019 (SI No. 30 of 2019) were published on the 8th of February 2019 and transpose Council Directive 2013/59/EURATOM (the Basic Safety Standards Directive).

 

The Basic Safety Standards Directive establishes basic safety standards for the protection of the health of individuals subject to occupational and public exposures against the dangers arising from ionising radiation. The Basic Safety Standards Directive replaces five earlier pieces of legislation which contained inconsistencies, did not fully reflect scientific progress or fully cover natural radiation sources or the protection of the environment. It sets out how to ensure the safety and security of radioactive material and the mandatory information that must be provided in the event of an exposure emergency.

 

The standards it contains are based on recommendations from the International Commission on Radiological Protection (ICRP).

 

The Directive applies to any planned, existing or emergency situation which involves a risk from exposure to ionising radiation. In particular, it applies to:

  • the manufacture, production, processing, handling, disposal, use, storage, holding, transport, import to and export from the EU of radioactive material;
  • the manufacture and operation of electrical equipment emitting ionising radiation;
  • human activities with natural radiation sources that could lead to a significant increase in the exposure of employees or the public, such as the exposure of space crew to cosmic radiation;
  • domestic exposure to radon gas in indoor air and external exposure to gamma radiation from building materials;
  • managing emergency exposure situations that require measures to protect the public and workers.

 

The Directive sets out general principles of radiation protection, giving a more prominent role to dose constraints for occupational, public and medical exposure. An annex lists the bands of reference levels proposed by the ICRP for existing and emergency exposure situations. Special provision is made to protect pregnant and breastfeeding employees and apprentices and students.

 

The Radiological Protection Act 1991 (Ionising Radiation) Regulations 2019 (SI No. 30 of 2019) also transpose certain provisions of Council Directive 2011/70/EURATOM (the Nuclear Waste Directive), establishing a Community framework for the responsible and safe management of spent fuel and radioactive waste.

 

The Regulations revoke the following legislation:

legislation change

The key changes are summarised below:

Part 1 – Citations, Definitions and Scope

Scope

The scope of the new Regulations includes any planned, existing or emergency exposure situation, which involves a risk from exposure to ionising radiation that cannot be disregarded from a radiation protection point of view or with regard to the environment in view of long-term human health protection.

Part 2 – Regulatory Control

Justification of Practices

The EPA introduces requirements addressing the justification of practices. Practices cannot be authorised unless it falls in a class or activity that is:

  • carried out immediately before the commencement of these Regulations
  • justified by the EPA with respect to its economic, social, health, environmental or other benefits
  • justified by the Health Information and Quality Authority with respect to medical exposures.

Graded Authorisation

The new Regulations introduce a system of tiered or graded authorisation covering both registration and licensing.  Registration will have a lower cost and administrative burden and will be appropriate to radiation practices, which have been shown to be of relatively low risk.  Licensing will continue to apply to high risk practices. Table 1 and Table 2 below detail the practices subject to registration and licensing respectively.

Table 1: Practices subject to registration

Industry Practice
Medical General radiography giving rise to a medical exposure in a medical radiological installation.  Note that CT, fluoroscopy, interventional and mobile X-ray remain subject to licensing.
Bone densitometry giving rise to a medical exposure
Mammography for health screening in a medical radiological installation
Specimen radiography for medical purposes
Dental Dental radiography using a fixed intra/extra oral unit
Dental cone beam CT in a risk assessed clinic
Veterinary General veterinary radiography carried out in a risked assessed veterinary clinic
Industry Product inspection/industrial radiography using cabinet X-ray systems
Use of laboratory equipment incorporating sealed sources
Use of XRF or XRD equipment
Transport Transport of source(s) other than High Activity Sealed Sources (HASS)
Security Security screening of baggage, cargo or parcels using X-ray within shielded enclosure
Security screening for explosive vapour detection using sealed sources

Table 2: Practices subject to licensing

Industry Practice
Medical Radiotherapy using a LINAC in a medical radiological installation
Radiotherapy using Brachytherapy in a medical radiological installation
Radiotherapy using X-Ray in a medical radiological installation
Interventional radiology giving rise to a medical exposure in a medical radiological installation
CT giving rise to a medical exposure in a medical radiological installation
Mobile radiography giving rise to a medical exposure in a medical radiological installation
Fluoroscopy giving rise to a medical exposure in a medical radiological installation
Nuclear medicine for treatment giving rise to a medical exposure in a medical radiological installation
Nuclear medicine for diagnosis giving rise to a medical exposure in a medical radiological installation
PET/CT giving rise to a medical exposure in a medical radiological installation
Dental Dental radiography using a mobile/handheld unit
Veterinary General veterinary radiography carried out in a risked assessed veterinary clinic
Veterinary radiotherapy
Veterinary nuclear medicine
Veterinary fluoroscopy
Veterinary radiography using CT
General veterinary radiography performed in the field
Industry Use of unsealed sources in industry/laboratories
Use of sealed sources in industrial process control
Use of nuclear moisture density gauges
Use of sealed sources in offshore exploration
Radiopharmaceutical production in a cyclotron
Product irradiation/sterilisation using sealed sources
Product irradiation/sterilisation using E-beams
Industrial radiography using X-ray systems
Industrial radiography using sealed sources
Assembly or manufacture of devices incorporating sealed sources
Transport Transport of High Activity Sealed Sources (HASS)
Security X-ray system for cargo/container screening of vehicles
Use of ionising radiation for non-medical human imaging
Education Use of ionising radiation for teaching or research in a third level college

Radioactive Waste Licences

The EPA has also introduced requirements pertaining to the licensing of radioactive waste management facilities or practices involving radioactive waste management. Applicants for such licenses are required to carry out a safety assessment covering the development, operation and decommissioning of the facility or practice. Furthermore, the disposal, recycling or reuse of radioactive materials arising from any authorised practice is subject to authorisation by the EPA.

Release from Regulatory Control

The new Regulations no longer allow the deliberate dilution of radioactive materials for the purpose of them being released from regulatory control.  The mixing of materials that takes place in normal operations where radioactivity is not a consideration is not subject to this prohibition.  The EPA may, in specific circumstances, authorise the mixing of radioactive and non-radioactive materials for the purposes of re-use or recycling.

Part 3 – System of Radiation Protection

Dose limit for Occupational Exposure

The Regulation introduces an effective dose for occupational exposure of 20mSV in any single year. The limit on the equivalent dose for the skin shall be 500 mSv in a year; this limit shall apply to the dose averaged over any area of 1 cm2, regardless of the area exposed; and the limit on the equivalent dose for the extremities shall be 500 mSv in a year.

The Regulation also introduces a reduced dose limit for occupational exposure to the lens of the eye.  The new limit on the equivalent dose for the lens of the eye is 20 mSv in a single year or 100 mSv in any five consecutive years subject to a maximum dose of 50 mSv in a single year.  The EPA will issue guidance in relation to acceptable measurement protocols for the measurement of eye dose.

Part 4 – Protection of Exposed Workers, Apprentices and Students

Responsibilities of the undertaking and employers

There are continued requirements to ensure that undertakings are responsible for assessing and implementing arrangements for the radiation protection of exposed workers, including outside workers, apprentices and students.

The new Regulation changes the definition of an “outside worker” to mean “any exposed worker who is not employed by the undertaking responsible for the supervised and controlled areas, but performs activities in those areas, including apprentices and students”.  Currently, only category A workers not employed by the undertaking are considered to be outside workers.  As a consequence of these new Regulations, a greater number of exposed workers will fall within the definition of outside worker.

Consultations with a Radiation Protection Adviser

In line with the Directive, the new Regulations will replace the current requirement to appoint a Radiation Protection Adviser (RPA) with a requirement to consult with an RPA in specified situations. Undertakings are required to provide the RPA with access to relevant information for the discharge of his or her functions in relation to the following:

  • the examination and testing of protective devices and measuring instruments;
  • the prior critical examination of plans for installations from the point of view of radiation protection
  • the acceptance into service of new or modified radiation sources from the point of view of radiation protection
  • the regular checking of the effectiveness of protective devices and techniques; and
  • the regular calibration of measuring instruments and the regular checking that they are serviceable and correctly used.

Role of Radiation Protection Officer

The new Regulations will set out a more defined role for Radiation Protection Officers (RPO).  It is envisaged that the RPO will be an individual or unit reporting directly to the undertaking with operational responsibility for radiation protection.

Depending on the nature of the practice, the tasks of the radiation protection officer in assisting the undertaking, may include the following:

  • ensuring that work with radiation is carried out in accordance with the requirements of any specified procedures and working instructions;
  • supervising the implementation of the programme for workplace monitoring;
  • maintaining adequate records of all radiation sources;
  • carrying out periodic assessments of the conditions of the relevant safety and warning systems;
  • supervising the implementation of the personal monitoring programme;
  • supervising the implementation of the health surveillance programme;
  • providing new workers with an appropriate introduction to specified procedures and working instructions;
  • giving advice and comments on work plans;
  • establishing work plans;
  • providing reports to the local management;
  • participating in the arrangements for prevention, preparedness and response for emergency exposure situations;
  • information and training of exposed workers; and
  • liaising with the radiation protection adviser.

Part 5 – Categorisation and Monitoring of Workers

Individual Monitoring

The Regulations have extended individual dose monitoring to outside workers; unlike the 1991 Order, which required individual dose monitoring of exposed workers, apprentices and students.

Furthermore, the new Regulations specifically state that undertakings must conduct individual dose monitoring in cases where exposed workers, outside workers, apprentices and students are liable to receive significant internal exposure or significant exposure of the lens of the eye or extremities. The 1991 Order limited individual dose monitoring requirements in cases where Category A workers are liable to receive significant internal contamination.

Part 7 – Emergency Preparedness and Response

Emergency Preparedness for Licensed Undertakings

The Regulations introduce new requirements for undertakings responsible for certain types of practice covering emergency arrangements. In the case of a practice which is subject to a licence, the undertaking must:

  • evaluate the possibility of a radiological emergency resulting from the practice and the potential for exposure of workers and members of the public; and
  • based on the evaluation, prepare an emergency response plan following consultation with a radiation protection adviser, the Agency and, where appropriate, the relevant local authority.

Part 8 – Naturally Occurring Radiation

Radon

The Regulations announce more rigorous protections with respect to indoor concentrations of radon in the workplace. The national reference level for radon levels in workplaces will decrease from 400 Bq/m3 to 300 Bq/m3. As a consequence of the new Regulations, there is a general duty on employers to carry out radon measurements in underground workplaces and in above ground workplaces identified as being liable to have high radon levels (based on the EPA’s radon risk map).

Part 9 – Control of Radioactive Sources

High-Activity Sealed sources

The new Regulations revoke and replace the Radiological Protection Act 1991 (Control of High-Activity Sealed Radioactive Sources) Order 2005 (SI No. 875 of 2005). Broadly speaking, the new Regulations are similar to the 2005 Order (link above). The requirements for undertakings responsible for a high-activity sealed source are now regulated in Schedule 12 of the new Regulations.

Part 10 – Services and Experts

Radiation Protection Advisers and Radiation Protection Officers

Regulations 79 and 80 of the Regulations place obligations on the EPA to establish criteria for the approval of Radiation Protection Advisers and set the minimum training requirements for Radiation Protection Officers.

Part 11 – Enforcement

Inspections and Enforcement Notices

This Part refers to the various powers the EPA holds in relation to inspections and serving enforcement notices.

Part 12 – Revocation of Legislation

Revocations

The following instruments are revoked:

 

The Pegasus Legal Register provides a detailed interpretation of the Radiological Protection Act 1991 (Ionising Radiation) Regulations 2019 (SI No. 30 of 2019), which enables companies to identify their obligations under these Regulations. Moreover, The Pegasus Legal Register also provides a detailed audit checklist against the requirements of these Regulations, which allows companies to measure their compliance against these Regulations. For further information on how the Pegasus Legal Register can help you manage your legal compliance, please email us on info@pegasuslegalregister.com.

Sources

Environmental Protection Agency

Tags
Health & Safety , ionising radiation , legislation update , Occupational Health & Safety , Radiological Protection Act 1991 (Ionising Radiation) Regulations
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