Consolidated Radiation Rules

The Commission has proposed a massive consolidation of the existing laws concerning exposure to radiation. The move will be of greater interest to legal and compliance personnel than to strategic types such as CEOs, as the rules themselves are not being radically changed.

That said, there will be an implementation of certain international recommendations into EU law, meaning some new requirements, new exposure scenarios, and other changes.

Due to the large number of articles in the legislative proposal, our briefing this week doubles as a guide to the text, with article ranges given for the respective sections.

Background

The Commission presented its legislative proposal on rules for the protection of the health of workers and the general public against ionising radiation on 29 September 2011. The Commission proposal aims to revise and consolidate a series of safety regulations on ionising radiation in order to update protection standards in line with international recommendations and make them easier to apply in practice.

The International Commission on Radiological Protection (ICRP) made new recommendations on the system of radiation protection in 2007, these recommendations have always been followed by the Commission.

Meanwhile, different radiation protection issues in the EU, defined as basic safety standards in the Euratom Treaty, are covered by a number of different Euratom Directives. In addition to inconsistencies and gaps in the legislation, flexibility given to Member States on defining industries working with naturally occurring radioactive materials (NORM) led to wide differences across Europe in controlling and protecting workers.

The Commission has therefore come forward with a proposal following extensive consultation and expert discussion to address 3 key problems:
• Scientific progress is not fully reflected in present legislation;
• There are inconsistencies between the existing pieces of legislation;
• The scope of the present legislation does not fully cover natural radiation sources or the protection of the environment, in line with the ICRP recommendations.

Aims of the proposal

In light of the problems with the current legislation the Commission’s proposal for a Council Directive aims to:
• to introduce substantive amendments in order to respond to the latest scientific data and operational experience;
• ensure coherence of European legislation and remove inconsistencies in the text;
• to ensure coherence with the international recommendations;
• to make sure the rules cover the whole range of exposure situations and categories of exposure.

Content of the Proposal

The proposal consists of a single Directive with over 100 articles and divided into 11 Chapters. The following sections give a summary description of the main features of each chapter.

Chapter 1 'Subject matter and scope' (Articles 1-3)

The Commission’s proposal for a Council Directive would merge the Directive 96/29/Euratom on Basic Safety Standards, the Directive 97/43/Euratom - the Medical Directive, Directive 2003/122/Euratom on High Activity Sealed Sources, Directive 90/641/Euratom on Outside Workers and Directive 89/618/Euratom on Public Information into a single text

The Chapter would also include an explicit article defining the general principles of the protection of the environment against dangers arising from ionising radiation. The scope of the Directive is broadened to include the exposure of space crew to cosmic radiation, domestic exposure to radon gas in indoor air, external exposure to gamma radiation from building materials and protection of the environment beyond environmental pathways leading to human exposure.

Radionuclides naturally contained in the human body, to cosmic radiation prevailing at ground level, and to aboveground exposure to radionuclides present in the undisturbed earth’s crust are excluded from the scope of the proposal.

Chapter 2 ‘Definitions’ (Article 4)

This section amends previous definitions to resolve inconsistencies and align definitions with new terminology introduced by the International Commission on Radiological Protection (ICRP) and the draft International Basic Safety Standards (BSS).

Chapter 3 ‘System of radiation protection’ (Articles 5-14)

This section sets out the requirements for the system of radiation protection – the regulatory control of exposure situations based on the principles of justification, optimisation and dose limitation.

Dosage limits are not modified, except for a uniform definition of the annual occupational dose limit (no longer averaging over 5 years) and a lower organ dose limit for the lens of the eye, as recommended by the ICRP.

The new Directive no longer includes the technical measurements entering into the definition of the effective dose and other factors entering into the assessment of doses, but refers to ICRP Publication 103 for this purpose. In addition, the Directive no longer includes the long lists of radionuclide-specific dose coefficients (doses per unit intake by ingestion or inhalation), but will refer to a forthcoming consolidated publication of the ICRP.

Chapter 4 ‘Requirements for radiation protection, education, training and information’ (Articles 15-19)

This section requires Member States to set up a legal and administrative framework to provide education training and information for radiation protection to workers that require it.

The Chapter covers information to be provided for workers, apprentices and students, workers at risk of exposure to orphan sources, emergency workers and medical exposure and includes recognition of new roles notably Radiation Protection Experts (RPE) and 'Medical Physics Experts'.

Chapter 5 ‘Justification and Regulatory Control of Practices’ (Articles 20-29)

This section presents the system for regulatory control to make sure new practices that result in exposure to ionising radiation are justified before being approved.

This is now presented as a three-tier system (notification, registration, licensing). A more detailed list of which types of practice are subject to either registration or licensing is also given and includes more precise requirements on the information to be provided with a licence application

Chapter 6 ‘Protection of Workers, Apprentices and Students’ (Articles 30-53)

This section covers occupational exposure and specific requirements from the Outside Workers Directive. It also introduces clear responsibilities between employer and the undertaking. The chapter now covers occupational exposure in all exposure situations, which provides more explicit protection for emergency workers as well as for workers exposed to high levels of indoor radon in their workplace.

Chapter 7 ‘Protection of Patients and other individuals subjected to medical exposure’ (Articles 54-63)

This section covers individuals subjected to medical exposure which includes relevant requirements from the Medical Directive to ensure that individual risks from the exposure of medical radiological staff and other personnel are taken into account, including specific provisions on vulnerable workers and accidental or unintended exposure. A list of practices involving non-medical imaging exposure is included in Annex IV to the proposal.

Chapter 8 ‘Protection of Members of the Public’ (Articles 64 – 75)

This section covers the protection of the public and is split into three Sections (1) Protection of the public in normal situations (2) Emergency exposure situations (3) Existing exposure situations where the proposal adds indoor exposure to existing exposure situations and classification of building materials.

Chapter 9 ‘Protection of the Environment’ (Articles 76-79)

The section requires Member States to include radiation protection provisions for non-human species in the environment and develop environmental criteria for this purpose. The section also requires Member States to require undertakings to avoid or mitigate ‘significant’ environmental damage in case of accidental releases and includes environmental monitoring.

Chapter 10 ‘Requirements for Regulatory Control’ (Articles 80-106)

This section sets out rule for the regulatory control in a clear structure divided into 6 sections: (1) Institutional infrastructure – covering the nomination of the competent authority and the recognition of services and experts and their roles (2) Control of sealed radioactive sources adequate with regard to their location, use and disuse and rules on record keeping (3) Orphan sources - covering detection, metal contamination, recovery, management and disposal and financial security of recover oprations (4) Emergency exposure situations – covering management systems, preparedness and international cooperation (5) Existing exposure situations on strategies for exposure situation and a strategy to manage long-term exposure risks from radon exposure in housing buildings and workplaces (6) System of enforcement - setting out requirements on inspections and penalties

Chapter 11 ‘Final Provisions’ (Articles 107-110)

The transposition of the Directive is expected to be set for 2 years after entry into force of the Directive, although new features such as protection of the environment could be transposed later.

The Annexes

The proposal also includes 16 Annexes providing detailed information on the following topics:

• Annex I - Bands of reference levels for public exposure
• Annex II - Activity values defining high-activity sealed sources
• Annex III - Placing on the market of apparatus or products
• Annex IV - Practices involving non-medical imaging exposure
• Annex V - List of industrial practices involving naturally occurring radioactive material
• Annex VI - Exemption and clearance criteria
• Annex VII - Definition and use of the activity concentration index for the gamma radiation emitted by building materials
• Annex VIII - Data system for individual radiological monitoring
• Annex IX - Elements to be included in an emergency management system and Elements to be included in an emergency response plan
• Annex X - Prior information to be provided the members of the public likely to be affected by an emergency and Information to be provided to the affected members of the public in the event of an emergency
• Annex XI – An indicative list of types of building materials considered for control measures with regard to their emitted gamma radiation
• Annex XII - Information to be provided in the records for high activity sealed sources
• Annex XIII - Provision of data on high-activity sealed sources
• Annex XIV - Requirements for undertakings responsible for a high-activity sealed source
• Annex XV - Identification and marking of high-activity sealed sources
• Annex VI - Indicative list of items to be covered in the national action plan to manage long term risks from radon exposures

Separate Rules for Radioactive Substances in Drinking Water

The Commission proposal does make an important exception because it does not include rules regulating radioactive substances in drinking water.

Instead the Commission has made by presenting a separate proposal for a Council Directive on the protection of the health of the general public with regard to radioactive substances in water intended for human consumption.

This proposal will cover rules on radioactive substances in drinking water and complement it with technical annexes on sampling frequencies, methods of analysis and detection levels replacing existing rules under Directive 98/83/EC – the Drinking Water Directive. The Commission intends to merge the eventual Council Directive into basic safety standards in the future.

Next Steps

The Commission's proposal follows the legislative procedure laid down under Article 31 of the Euratom Treaty. The European Parliament can give its opinion on the proposal but cannot reject or propose amendments to the text.

The proposal will be discussed by the EU institutions during 2011 and 2012. A period of one to two years can be expected for discussions in the Council's Atomic Questions Group (Member State experts) before adoption by the Council.

The Directive is not expected to be transposed in the Member States until 2014 / 2015, because of the complexity of the subject matter.