KEW/Euratom (In Europe and Internationally)

Abstract

Radioactivity is a natural phenomenon, and ionizing radiation and radioactive substances have many beneficial applications, ranging from power generation to uses in medicine, industry, and agriculture. At the same time, ionizing radiation is a cause of concern because the exposure of the human body may cause health detriment.

Appendices

Appendices

1.1 Appendix I: Outline of the Revised BSS Directive

The recast of the five directives yields a voluminous single directive, with over 100 articles and numerous annexes. The different chapters and the main changes in each chapter as published by the Euratom are listed below. Regulations with regard to the protection of patients are given in chapter VII. This chapter includes ten Articles that are listed in Appendix II.

1.1.1 Chapter I: Subject Matter and Scope

This chapter defines the scope of the new directive (general purpose of the directive across different categories of exposure and different exposure situations and specific purposes resulting from integration of the requirements for high-activity sealed radioactive sources and for public information and the exclusion of noncontrollable exposures). The scope 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 the protection of the environment beyond environmental pathways leading to human exposure.

1.1.2 Chapter II: Definitions

This chapter includes all definitions given in the earlier directives, with some adjustments to resolve inconsistencies as well as to adjust to the new terminology introduced in ICRP Publication 103 and in the draft International Basic Safety Standards.

1.1.3 Chapter III: System of Radiation Protection

This title includes the general principles of radiation protection: justification, optimization, and dose limitation. It explains the more prominent role of dose constraints and reference levels in the process of optimization, with Annex I giving the bands of reference levels proposed by the ICRP for existing and emergency exposure situations. The dose limits are not modified, except for a uniform definition of the annual occupational dose limit (no 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 which can be downloaded free of charge.

1.1.4 Chapter IV: Requirements for Radiation Protection Education, Training, and Information

This chapter brings together the miscellaneous requirements governing education and training in the different directives and includes provisions for recognition of the “Radiation Protection Expert” and “Medical Physics Expert.”

1.1.5 Chapter V: Justification and Regulatory Control of Practices

The application of the principle of justification remains a national responsibility. Specific attention is given to the justification of practices involving the deliberate exposure of humans for nonmedical imaging (e.g., security screening in airports).

The regime for regulatory control is now presented as a three-tier system (notification, registration, licensing), replacing the earlier two-tier system of reporting and “prior authorization.” A more detailed list of which types of practice are subject to either registration or licensing is given. As part of the concept of a “graded approach” to regulatory control, there is explicit provision for the specific exemption of practices (from notification and from authorization) at national level. The default values for exemption on the basis of activity concentrations are now taken from IAEA Safety Guide RS-G-1.7. The same default values apply to release from regulatory control (clearance levels), but allow for specific values in European guidance. Member States will be allowed to keep default clearance levels in current national legislation and to keep the existing exemption values for moderate amounts of material. Details of exemption criteria and exemption and clearance levels are given in Annex VI.

This chapter also includes more precise requirements on the information to be provided with a license application (the issuing of discharge authorizations for radioactive airborne or liquid effluent is covered in Chapter VIII).

1.1.6 Chapter VI: Protection of Workers, Apprentices, and Students

This title includes, with little amendment, the provisions on occupational exposure in Directive 96/29/Euratom. It also includes the specific requirements in the Outside Workers Directive and introduces a clear allocation of responsibilities between the employer and the undertaking where the practice is conducted. The data system for individual radiological monitoring of exposed workers and the minimum set of data to be communicated for outside workers has been updated in the light of recommendations by HERCA.

No distinction is made between the management of occupational exposures in NORM industries and other practices, but the former will benefit from a graded regulatory approach on the basis of prevailing exposures and their potential to increase with time.

This 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.

1.1.7 Chapter VII: Protection of Patients and Other Individuals Subjected to Medical Exposure

This chapter includes the relevant requirements from the Medical Directive, but strengthens them, in particular with regard to:

• The application of the justification principle

• Information to patients on the health risks and benefits

• Information on doses

• Diagnostic reference levels

• Involvement of the Medical Physics Expert

• Prevention of accidental and unintended medical exposures

1.1.8 Chapter VIII: Protection of Members of the Public

This chapter includes the public exposure requirements in Directive 96/29/Euratom, with more explicit consideration of the issuing of discharge authorizations for radioactive effluent (also with reference to Commission Recommendation 2004/2/Euratom).

The section on emergency exposure situations includes the requirements of the Public Information Directive.

The section on existing exposure situations addresses indoor exposure to radon, with a somewhat lower maximum reference level for existing dwellings than in Commission Recommendation 90/143/Euratom, in line with ICRP and WHO recommendations. It also includes requirements for the classification of building materials on the basis of a radioactivity index and a uniform reference level for the annual dose resulting from residence in a building constructed with such materials.

1.1.9 Chapter IX: Protection of the Environment

This chapter, in line with the broader scope of the directive as in the International Basic Safety Standards, aims to provide a means to demonstrate compliance with environmental criteria. While the ICRP has published a methodology for dose assessment for biota, a publication on the application of criteria is still awaited. Pending such further guidance, it is up to national authorities to assess the doses to representative animals and plants in terms of protection of the ecosystem.

Appropriate technical measures also need to be taken to avoid the environmental consequences of an accidental release and to monitor existing levels of radioactivity in the environment, from the perspectives of both environmental protection and human health.

1.1.10 Chapter X: Requirements for Regulatory Control

This chapter includes all the responsibilities of the regulatory authorities in all exposure situations. A clear structure is provided by the following sections:

• Institutional infrastructure

• Control of sealed radioactive sources (with Annexes II, XII, XIII, XIV, XV incorporating different aspects of the directive on high-activity sealed radioactive sources)

• Orphan sources (with new requirements with regard to metal contamination)

• Emergency exposure situations (establishment of an emergency management system and international cooperation, while requirements for the protection of workers and members of the public in an emergency exposure situation are addressed in Chapters V and VIII, respectively)

• Existing exposure situations (general provisions for the management of contaminated areas, radon action plan)

• System of enforcement (inspection program and response to deficiencies)

The first section on “institutional infrastructure” calls for a clear definition of the responsibilities of different authorities. The Commission is to receive periodically updated information and publish this in the Official Journal. This section also defines the responsibilities of the “Radiation Protection Expert,” the “Radiation Protection Officer” (in the current BSS these concepts were merged within the function of “Qualified Expert”), and the “Medical Physics Expert.”

1.1.11 Chapter XI: Final Provisions

The transposition of the new directive into national law should not require a major legislative effort, so a 2-year transposition deadline is deemed sufficient. Specific new features, such as the protection of the environment, can be transposed later.

In line with the Euratom Treaty, the Basic Standards are to be uniformly applied in the Member States, though without prejudice to those requirements for which flexibility is clear from the wording of the text. However, dose limits, default exemption values, the reference level for building materials, etc. are explicitly intended for uniform transposition and application.

1.2 Appendix II: Regulation for the Protection of Patients in European Legislation

The revised BSS Directive yields over 100 articles divided over eleven chapters and numerous annexes. Regulations with regard to the protection of patients are given in Chapter VII. The Articles in this chapter, as described in the “Proposal for a Council Directive laying down basic safety standards against the dangers arising from exposure to ionizing radiation” (com(2012)242), are given below.

The full text of the directive can be found on the website of European Commission (http://ec.europa.eu/energy/nuclear/radiation_protection/doc/2012_com_242.pdf).

1.2.1 Chapter VII: Protection of Patients and Other Individuals Subjected to Medical Exposure

Article 54: Justification

• 1. Medical exposure shall show a sufficient net benefit, weighing the total potential diagnostic or therapeutic benefits it produces, including the direct benefits to health or well-being of an individual and the benefits to society, against the individual detriment that the exposure might cause, taking into account the efficacy, benefits and risks of available alternative techniques having the same objective but involving no or less exposure to ionising radiation.

  Account shall also be taken of the individual detriment from the exposure of the medical radiological staff and other individuals.

  • (a) all new types of practices involving medical exposure shall be justified in advance before being generally adopted;

    existing types of practices involving medical exposure shall be reviewed whenever new, important evidence about their efficacy or consequences is acquired;

    all individual medical exposures shall be justified in advance taking into account the specific objectives of the exposure and the characteristics of the individual involved.

    If a type of practice involving a medical exposure is not justified in general, a specific individual exposure of this type may be justified in special circumstances, to be evaluated on a case-by-case basis and documented.

    The referrer and the practitioner shall seek, where practicable, to obtain previous diagnostic information or medical records relevant to the planned exposure and consider these data to avoid unnecessary exposure.

  In particular the following requirements shall be applied:

• 2. Medical exposure for biomedical and medical research shall be examined by an ethics committee, set up in accordance with national procedures and/or by the competent authorities;

• 3. Specific justification for medical radiological procedures to be performed as part of a health screening programme shall be carried out by the health authority in conjunction with appropriate professional bodies.

• 4. The exposure of carers and comforters shall show a sufficient net benefit, taking into account the direct health benefits to a patient, the benefits to the carer / comforter and the detriment that the exposure might cause.

• 5. Any medical radiological procedure on an asymptomatic individual, to be performed for the early detection of disease, shall be part of a health screening programme, or shall require specific documented justification for that individual by the practitioner, in consultation with the referrer, following guidelines from relevant professional bodies and competent authorities. Special attention shall be given to the provision of information to the patients, as required by Article 56(3).

• 6. If an exposure cannot be justified in accordance with paragraphs 1 to 5, it shall be prohibited.

Article 55: Optimisation

• 1. All doses due to medical exposure for radiodiagnostic and interventional radiology purposes shall be kept as low as reasonably achievable consistent with obtaining the required imaging information, taking into account economic and social factors.

  For all medical exposure of individuals for radiotherapeutic purposes, exposures of target volumes shall be individually planned, taking into account that doses of non-target volumes and tissues shall be as low as reasonably achievable and consistent with the intended radiotherapeutic purpose of the exposure.

• 2. Member States shall ensure the establishment, regular review and use of diagnostic reference levels for radiodiagnostic examinations, and when appropriate, for interventional radiology procedures, and the availability of guidance for this purpose.

• 3. Member States shall ensure that for each biomedical and medical research project:

  • (a) the individuals concerned participate voluntarily;

    these individuals are informed about the risks of exposure;

    a dose constraint is established for individuals for whom no direct medical benefit is expected from exposure;

    in the case of patients who voluntarily accept to undergo an experimental diagnostic or therapeutic practice and who are expected to receive a diagnostic or therapeutic benefit from this practice, the dose levels concerned shall be considered on an individual basis by the practitioner and/or referrer.

• 4. The optimisation shall include the selection of equipment, the consistent production of adequate diagnostic information or therapeutic outcomes, the practical aspects of medical exposure procedures, quality assurance, and the assessment and evaluation of patient and staff doses or administered activities, taking into account economic and social factors.

• 5. Member States shall ensure that:

  • (a) dose constraints are established for the exposure of carers and comforters;

    appropriate guidance is established for the exposure of carers and comforters;

• 6. Member States shall ensure that in the case of a patient undergoing treatment or diagnosis with radionuclides, the practitioner or the undertaking, as appropriate, provides the patient or legal guardian with written instructions with a view to restricting doses to persons in contact with the patient as far as reasonably achievable and providing information on the risks of ionising radiation.

  These instructions shall be handed out before leaving the hospital or clinic or a similar institution.

Article 56: Responsibilities

• 1. The referrer and the practitioner shall be involved in the justification process as specified by Member States.

• 2. Member States shall ensure that any medical exposure takes place under the clinical responsibility of a practitioner.

• 3. The practitioner shall ensure that the patient or legal guardian is provided with adequate information relating to the benefits and risks associated with the radiation dose from the medical exposure to enable informed consent. Similar information as well as relevant guidance in accordance with Article 55(5)(b) shall be given to carers and comforters.

• 4. Practical aspects of medical exposure procedures may be delegated by the undertaking or the practitioner, as appropriate, to one or more individuals entitled to act in this respect in a recognised field of specialisation.

Article 57: Procedures

• 1. Written protocols for every type of standard medical radiological procedure shall be established for each equipment.

• 2. Member States shall ensure that referral guidelines for medical imaging, taking into account the radiation doses, are available to the referrers.

• 3. In medical radiological practices, a medical physics expert shall be appropriately involved, the level of involvement being commensurate with the radiological risk posed by the practice. In particular:

  • (a) in radiotherapeutic practices other than standardised therapeutic nuclear medicine practices, a medical physics expert shall be closely involved;

    in standardised therapeutical nuclear medicine practices as well as in radiodiagnostic and interventional radiology practices, a medical physics expert shall be involved;

    for other simple radiodiagnostic procedures, a medical physics expert shall be involved, as appropriate, for consultation and advice on matters relating to radiation protection concerning medical exposure.

• 4. Clinical audits shall be carried out in accordance with national procedures.

• 5. Member States shall ensure that appropriate local reviews are undertaken whenever diagnostic reference levels are consistently exceeded and that corrective action is taken where appropriate.

Article 58: Training

Member States shall ensure that training and recognition requirements, as laid down in Articles 15, 19 and 81, are met for the practitioner, the medical physics expert and the individuals referred to in Article 56(4).

Article 59: Equipment

• 1. Member States shall take such steps as they consider necessary with a view to avoiding unnecessary proliferation of medical radiological equipment.

• 2. Member States shall ensure that:

  • (a) all medical radiological equipment in use is kept under strict surveillance regarding radiation protection;

    an up-to-date inventory of medical radiological equipment for each medical radiological installation is available to the competent authorities;

    appropriate quality assurance programmes and dose or administered activity assessments are implemented by the undertaking; and

    acceptance testing, involving the medical physics expert, is carried out before the first use of the equipment for clinical purposes, and performance testing is carried out thereafter on a regular basis, and after any major maintenance procedure.

• 3. Competent authorities shall take steps to ensure that the necessary measures are taken by the undertaking to improve inadequate or defective features of medical radiological equipment. They shall also adopt specific criteria for the acceptability of equipment in order to indicate when appropriate corrective action is necessary, including, if appropriate, taking the equipment out of service.

• 4. The use of fluoroscopy equipment without a device to control the dose rate, or without an image intensifier or equivalent device, shall be prohibited.

• 5. Any equipment used for interventional radiology and computed tomography shall have a device or a feature informing the practitioner of the quantity of radiation produced by the equipment during the medical radiological procedure. Any other medical radiodiagnostic equipment brought into use after this Directive has entered into force shall have such a device or a feature or equivalent means of determining the quantity of radiation produced. The radiation dose shall form part of the report on the examination.

Article 60: Special practices

• 1. Member States shall ensure that appropriate medical radiological equipment, practical techniques and ancillary equipment are used for medical exposure

  • (a) of children;

    as part of a health screening programme;

    involving high doses to the patient, such as interventional radiology, computed tomography or radiotherapy.

    Special attention shall be given to quality assurance programmes and the assessment of dose or administered activity, as mentioned in Article 59(2)(c), for these practices.

• 2. Member States shall ensure that practitioners and those individuals referred to in Article 56(4) who perform the exposures referred to in paragraph 1 of this Article obtain appropriate training in these medical radiological practices as required by Article 19.

Article 61: Special protection during pregnancy and breastfeeding

• 1. In the case of a woman of childbearing age, the referrer and the practitioner shall inquire as specified by Member States whether she is pregnant or breastfeeding, if relevant.

  If pregnancy cannot be excluded, depending on the type of medical exposure, in particular if abdominal and pelvic regions are involved, special attention shall be given to the justification, particularly the urgency, and to the optimisation of the medical exposure, taking into account the exposure both of the expectant mother and the unborn child.

• 2. In the case of breastfeeding women, in nuclear medicine, depending on the type of medical examination or treatment, special attention shall be given to the justification, particularly the urgency, and to the optimisation of the medical exposure, taking into account the exposure both of the mother and the child.

• 3. Without prejudice to paragraphs 1 and 2, Member States shall take measures to increase the awareness of women to whom this Article applies, such as public notices in appropriate places.

Article 62: Accidental and unintended exposures

Member States shall ensure that:

• (a) all reasonable steps are taken to minimizse the probability and magnitude of accidental or unintended exposures of patients from all medical radiological procedures, taking into account economic and social factors;

  for radiotherapeutic practices the quality assurance programme includes a study of the risk of accidental or unintended exposures;

  for all medical exposures the undertaking implements a system for the registration and analysis of events involving or potentially involving accidental or unintended exposures;

  the undertaking declares as soon as possible to the competent authorities the occurrence of significant events as defined by the authorities, including the results of the investigation and the corrective measures to avoid such events. The competent authorities shall share this information with the competent authorities for post-market surveillance established in Council Directive 93/42/EEC concerning medical devices;

  arrangements are made to inform the referrer, the practitioner and the patient about an unintended or accidental exposure.

Article 63: Estimates of population doses

Member States shall ensure that the distribution of individual dose estimates from medical exposure is determined and shall take into account the age distribution and the gender of the exposed population.

1.3 Appendix III: Medical Guidance Documents Published by Euratom

Since 1976 the European Commission has published a large number of publications covering a wide range of issues relating to ionizing radiation and radiation protection (radiation protection series). A complete list can be found on the website of Euratom (http://ec.europe.eu/energy/nuclear/radiation_protection/publications_en.htm). The following radiation protection publications dealing with medical exposures have been issued in the past decade or so and are expected to still have relevance today:

RP 172:

Cone beam CT for dental and maxillofacial radiology – evidence-based guidelines

RP 162:

Criteria for acceptability of medical radiological equipment used in diagnostic radiology, nuclear medicine, and radiotherapy

RP 159:

European Commission guidelines on clinical audit

RP 158:

EU Scientific Seminar 2008 – Emerging evidence for radiation induced circulatory diseases

RP 154:

European guidance on estimating population doses from medical X-ray procedures and annexes

RP 149:

EU Scientific Seminar 2003, medical overexposures

RP 136:

European guidelines on radiation protection in dental radiology

RP 131:

Effects of in utero exposure to ionizing radiation during the early phases of pregnancy

RP 130:

Medicolegal exposures, exposures with ionizing radiation without medical indication proceedings of the International Symposium, Dublin, 4–6 September 2002

RP 119:

Multimedia and audiovisual radiation protection training in interventional radiology

RP 116:

Guidelines on education and training in radiation protection for medical exposures (in the process of update)

RP 109:

Guidance on diagnostic reference levels (DRLs) for medical exposures

RP 102:

Proceedings of the workshop “Implementation of the Medical Exposure Directive (97/43/EURATOM)” – Madrid on 27 April 1998

RP 100:

Guidance for protection of unborn children and infants irradiated due to parental medical exposures

RP 99:

Guidance on medical exposures in medical and biomedical research

RP 97:

Radiation protection following iodine-131 therapy (exposures due to outpatients or discharged inpatients)

1.4 Appendix IV: Guidance Documents Published by ICRP

Since 1928 the ICRP has published a large number of publications covering a wide range of issues relating to ionizing radiation and radiation protection (Annals of the ICRP). Publications dealing with specific aspects of radiological protection in medicine that were published in the last years are listed below. A complete overview of the published documents and additional information can be found on the website of the ICRP (http://www.icrp.org/publications.asp).

ICRP, Khong P-L, Ringertz H, Donoghue V, Frush D, Rehani M, Appelgate K, Sanchez R. Radiological protection in paediatric diagnostic and interventional radiology. ICRP Publication 121. Ann ICRP. 2013;42(2).

ICRP, Cousins C, Miller DL, Bernardi G, Rehani MM, Schofield P, Vaño E, Einstein AJ, Geiger B, Heintz P, Padovani R, Sim K-H. Radiological Protection in Cardiology. ICRP Publication 120. Ann ICRP. 2013;42(1).

ICRP, Stewart FA, Akleyev AV, Hauer-Jensen M, Hendry JH, Kleiman NJ, MacVittie TJ, Aleman BM, Edgar AB, Mabuchi K, Muirhead CR, Shore RE, Wallace WH. ICRP Statement on Tissue Reactions / Early and Late Effects of Radiation in Normal Tissues and Organs – Threshold Doses for Tissue Reactions in a Radiation Protection Context. ICRP Publication 118. Ann ICRP. 2012;41(1/2).

ICRP, Rehani MM, Ciraj-Bjelac O, Vaño E, Miller DL, Walsh S, Giordano BD, Persliden J. Radiological Protection in Fluoroscopically Guided Procedures outside the Imaging Department. ICRP Publication 117. Ann. ICRP. 2010;40(6).

ICRP, Petoussi-Henss N, Bolch WE, Eckerman KF, Endo A, Hertel N, Hunt J, Pelliccioni M, Schlattl H, Zankl M. Conversion Coefficients for Radiological Protection Quantities for External Radiation Exposures. ICRP Publication 116, Ann ICRP. 2010;40(2–5).

ICRP, Vaño E, Rosenstein M, Liniecki J, Rehani M, Martin CJ, Vetter RJ. Education and Training in Radiological Protection for Diagnostic and Interventional Procedures. ICRP Publication 113. Ann ICRP. 2009;39 (5).

ICRP. Adult Reference Computational Phantoms. ICRP Publication 110. Ann ICRP. 2009;39(2).

ICRP. Nuclear Decay Data for Dosimetric Calculations. ICRP Publication 107. Ann ICRP. 2008;38(3).

ICRP. Radiation Dose to Patients from Radiopharmaceuticals – Addendum 3 to ICRP 53. ICRP Publication 106. Ann ICRP. 2008;38 (1–2).

ICRP. Radiological Protection in Medicine. ICRP Publication 105. Ann ICRP. 2007:37(6).

ICRP. 2007 Recommendations of the International Commission on Radiological Protection (Users Edition). ICRP Publication 103 (Users Edition). Ann ICRP. 2007;37(2–4).

ICRP. Managing Patient Dose in Multi-Detector Computed Tomography (MDCT). ICRP Publication 102. Ann ICRP. 2007;37(1).