NOTIFICATION, AUTHORIZATION (REGISTRATION AND LICENSING)
3. SOME CRITICAL POINTS 1. Emphasis needed
An established regulatory system alone is no assurance of continuing proper radiation protection and safety. Emphasis should be kept regularly on typical critical points which may cause deficiencies to radiation protection and safety. According to the experience in many states, such critical points are the following:
(1) lack of training of persons engaged and lack of respect of the authority on the part of persons responsible,
(2) drop-off in reliability (interest, dependability) due to routine or overburden of persons engaged,
(3) loss of knowledge and/or care about existing sources, namely when facilities are closed down without prompt dissolving or when responsible persons leave a facility,
(4) lack of possibilities to dispose spent sources,
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(5) weak standing of the competent authority (e.g., lack of competence or of qual-ified staff, insufficient inspections).
Such cases may have severe consequences, such as loss of control of sources, often leading to high exposures, spread of contamination or at least to increased potential exposures. Even strenuous efforts to find lost sources are often without success. Several fatalities due to exposures from sources coming out of control have been reported [21, 22].
The cleaning of contaminated facilities or areas and rejection of contaminated products cause very high expenses. The scrap metal industry, steel mills, foundries and customs services have established control measurements [23].
3.2. Some countermeasures
Unusual events show that the causes of deficiencies are mostly incorrect human conduct that can hardly be avoided completely by rules or supervision. But some regulatory measures may support recognition of incorrect behaviour or the potential of it and enable the authority to act. Considering the critical points mentioned which may lead to loss of control of sources, the following measures are seen as helpful:
(a) Sufficient regular inspections by the authority in the collegial sense mentioned in Section 2.7 are the most effective measures, but they are intensive in personnel, knowledge and costs.
(b) Requiring periodic inventories of sources and prompt reporting of changes due to receipts and shipments (e.g. in Germany, inventory yearly and changes within one month [24]); authority evaluates submitted data, notes missed reporting deadlines and acts if deficiencies are found.
(c) Appropriate wide use of periodic leakage tests (by the user or preferably by an external expert) and prompt submission of results to the authority as a further contribution to the control source inventory.
(d) Periodic checks (radiation protection, safety) of equipment by an external expert (e.g. yearly, as established in Germany by a legal requirement for sources of more than 20 TBq [24]), including proper control of the source inventory and any relevant changes.
(e) Prompt notification of the authority if registrant's or licensee's evaluation suggests losses, unauthorized use or removal of sources. The authority should encourage such notifications as a basis for initiating countermeasures at an early stage to prevent potential exposures and avoid high expenses for search operations. It should be noted that punishment is not the motivation for this notification. This prompt notification must also be required of all authorities
engaged in the control of sources, namely (in addition to the radiation protec-tion authorities) the police and customs authorities.
(f) Avoiding storage of spent sources on the facility's site by offering storage centres which keep these sources for later release, recycling or transfer to final disposal.
4. CONCLUSIONS
Using the international framework of guidance for establishing or amending regulatory control provides the following benefits:
(a) protection and safety regulations will be to the state of the art,
(b) a valuable profit from the lessons learned worldwide is integrated (i.e., the repetition of already analysed regulatory deficiencies, misuses or malfunctions is avoided),
(c) confidence in protection and safety measures is encouraged,
(d) recognition of authorizations and approvals given is supported (the importance of this issue is likely to grow along with international economic co-operation).
On-site inspections are essential for the actual monitoring of compliance but also for reviewing safety culture, optimization and regulatory infrastructure.
These features can be effective only when competent State bodies permanently pay attention to implementation and (as necessary) to improvements.
Consideration should be given to the establishment of a registry of those sources which have the potential to create severe hazards when uncontrolled. Such registries should be built up at least by each authorization authority and preferably should be centralized nationwide. Such registries may support search operations (by facilitating identification and ownership histories of sources) and help to assess deficiencies (lessons learned).
Based on such registries, the IAEA and the Member States might wish to con-sider building up a registry of sources lost and of sources found whose holders can-not be identified. Some recent finds [25, 26] have shown that investigation needs international assistance.
REFERENCES
[1] INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, Radiation Protection — Sealed Radioactive Sources — General Regulations and Classification, ISO 2919, ISO Geneva (1998).
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[2] INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, Radiation Protection — Sealed Radioactive Sources — Leakage Test Methods, ISO 9978, ISO, Geneva (1992).
[3] INTERNATIONAL ATOMIC ENERGY AGENCY, Regulations for the Safe Transport of Radioactive Material, Safety Standards Series No. ST-1, IAEA, Vienna (1996).
[4] INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, 1990 Recommendations of the International Commission on Radiological Protection, Publication 60, Pergamon Press, Oxford and New York (1991).
[5] FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS, INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR ORGANISATION, OECD NUCLEAR ENERGY AGENCY, PAN AMERICAN HEALTH ORGANIZATION, WORLD HEALTH ORGANIZATION, Radiation Protection and the Safety of Radiation Sources, Safety Series No. 120, IAEA, Vienna (1996).
[6] FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS, INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR ORGANISATION, OECD NUCLEAR ENERGY AGENCY, PAN AMERICAN HEALTH ORGANIZATION, WORLD HEALTH ORGANIZATION, International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources, Safety Series No. 115, IAEA, Vienna (1996).
[7] INTERNATIONAL ELECTROTECHNICAL COMMISSION, Medical Electrical Equipment — Part 2: Particular Requirements for the Safety of Gamma Beam Therapy Equipment, IEC 60601-2-11, IEC, Geneva (1997).
[8] INTERNATIONAL ATOMIC ENERGY AGENCY, Practical Radiation Safety Manual, Manual on Nuclear Gauges, IAEA-PRSM-3 (Rev. 1), IAEA, Vienna (1996).
[9] INTERNATIONAL ATOMIC ENERGY AGENCY, Establishing a National System for Radioactive Waste Management, Safety Series No. 111-S-l, IAEA, Vienna (1995).
[10] INTERNATIONAL ATOMIC ENERGY AGENCY, Conditioning and Interim Storage of Spent Radium Sources, IAEA-TECDOC-886, Vienna (1996).
[11] INTERNATIONAL COMMISSION ON RADIATION UNITS AND MEASURE-MENTS, Quantities and Units in Radiation Protection Dosimetry, ICRU Rep. 51, ICRU, Bethesda, MD (1993).
[12] INTERNATIONAL ATOMIC ENERGY AGENCY, Organization and implementation of a national regulatory infrastructure governing protection against ionizing radiation and the safety of radiation sources (in preparation).
[13] INTERNATIONAL ATOMIC ENERGY AGENCY, Safety of Radiation Sources (in preparation).
[14] EUROPEAN UNION, Council Directive 96/29/EURATOM of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation, Official J. European Communities L 159, 39 (29 June 1996) 1.
[15] INTERNATIONAL ATOMIC ENERGY AGENCY, Principles for the Exemption of Radiation Sources and Practices from Regulatory Control, Safety Series No. 89, IAEA, Vienna (1988).
[16] EUROPEAN COMMISSION, Principles and Methods for Establishing Concentrations and Quantities (Exemption Values) Below which Reporting is not Required in the European Directive, Radiation Protection 65, European Commission Directorate General XI, Brussels (1993).
[17] INTERNATIONAL ATOMIC ENERGY AGENCY, Clearance Levels for Radionuclides in Solid Materials: Application of Exemption Principles (Interim Report for Comment), IAEA-TECDOC-855, Vienna (1996).
[18] INTERNATIONAL ATOMIC ENERGY AGENCY, Clearance of Materials Resulting from the Use of Radionuclides in Medicine, Industry and Research,
IAEA-TECDOC-1000, Vienna (1998).
[19] GERMAN COMMISSION ON RADIOLOGICAL PROTECTION, Clearance of mate-rials, buildings and sites with negligible radioactivity from practices subject to reporting or authorization, Recommendation, Bundesministerium fur Umwelt, Naturschutz und Reaktorsicherheit, Bonn (in press).
[20] COMMISSION OF THE EUROPEAN COMMUNITIES, Recommended Radiological Protection Criteria for the Recycling of Metals from the Dismantling of Nuclear Installations, Radiation Protection 89, European Commission Directorate General XI, Brussels (1998).
[21] INTERNATIONAL ATOMIC ENERGY AGENCY, The Radiological Accident in Goiania, IAEA, Vienna (1988).
[22] INTERNATIONAL ATOMIC ENERGY AGENCY, The Radiological Accident in Tammiku, Estonia, IAEA, Vienna (199?).
[23] BUNDESMINISTERIUM FUR UMWELT, NATURSCHUTZ UND REAKTOR-SICHERHEIT, Spezifische Strahlenschutzanalysen in Verbindung mil kontaminierten Schrotten fur Zwecke der Aufsicht (Radiation Protection Aspects Covering Contaminated Scrap), Schriftenreihe Reaktorsicherheit und Strahlenschutz Nr. 1988-499 (ISSN 0724-3316) (results to be presented at II. Internatl Symp. on Naturally Occurring Radioactive Materials, 10-13 November 1998, Krefeld, Germany).
[24] BUNDESMINISTERIUM FUR UMWELT, NATURSCHUTZ UND REAKTOR-SICHERHEIT, English translation of the German Radiation Protection Ordinance on the Protection Against Damage and Injuries Caused by Ionizing Radiation (1989).
[25] GESELLSCHAFT FUR ANLAGEN- UND REAKTORSICHERHEIT, Discovery of a Cs-137 source with about 200 GBq on a scrap yard in Germany, 1997/05/15, GRS, Cologne (1997).
[26] AZUARA, J.A., IAEA-CN-70/B 1.2, these Proceedings.