Table of contents

1..................... Introduction.. 4

2..................... High Activity Sealed Sources inventory in Europe.. 4

3..................... Implementation of Directive 2003/122/EURATOM... 5

3.1.................. Overview.. 5

3.2.................. Areas of inconsistent implementation of the Directive. 5

3.1.................. Areas of difficult implementation of the Directive. 6

3.2.................. Recommendations for improved implementation of the Directive. 6

3.3.................. Best practices in implementation. 7

4..................... Implementation status in the Member States (EU-27) 9

4.1.................. Austria. 9

4.2.................. Belgium.. 13

4.3.................. Bulgaria. 17

4.4.................. Cyprus. 21

4.5.................. Czech Republic. 25

4.6.................. Denmark. 29

4.7.................. Estonia. 32

4.8.................. Finland. 37

4.9.................. France. 41

4.10................ Germany. 48

4.11................ Greece. 52

4.12................ Hungary. 56

4.13................ Ireland. 61

4.14................ Italy. 65

4.15................ Latvia. 69

4.16................ Lithuania. 73

4.17................ Luxembourg. 78

4.18................ Malta. 82

4.19................ The Netherlands. 87

4.20................ Poland. 93

4.21................ Portugal 97

4.22................ Romania. 102

4.23................ Slovakia. 105

4.24................ Slovenia. 109

4.25................ Spain. 113

4.26................ Sweden. 117

4.27................ United Kingdom.. 121

5..................... Loss of HASS control incidents in Europe.. 125

6..................... Development of HASS regulations in the EU.. 126

6.1.................. Directive 2003/122/EURATOM requirements as a part of the new EU Basic Safety Standards Directive 2013/59/EURATOM... 126

6.2.................. Regulatory harmonisation with the IAEA.. 126

6.3.................. Other changes. 128

7..................... Conclusions. 128

Executive summary

European Union Council Directive 2003/122/EURATOM (so called 'HASS Directive') requires the EU Member States to put in place several measures in order to guarantee the safety and security of high-activity sealed radioactive sources (HASS) and to search for orphan sources. These legally binding measures are in line with the requirements of the IAEA Code of Conduct on the Safety and Security of Radioactive Sources. This document discusses the results of the recent HASS Directive implementation review and the results of a supporting study project under the EU CBRN Action Plan. The document also outlines the current development of the HASS-legislation in the EU, especially in terms of the new EU Basic Safety Standards (BSS) Directive.

To assess the implementation status, compliance of the current situation prevailing in each Member State[1] with 17 major requirements of the HASS Directive was checked through the analysis of information collected by questionnaires, interviews and fact-finding missions among the European stakeholders. There is in general a good compliance of the implementation of the HASS Directive requirements. The only difficult area in implementation is the organization of orphan source recovery campaigns, which have been implemented in only about 50% of the Member States.

The analysis of the level of implementation of the HASS requirements in the 27 Member States was deepened to identify the best practices, weak points and points of attention from the safety and security perspective. Indeed, there are significant differences in implementing practices among the EU Member States. The best implemented requirements deal with the availability of a complete central inventory of all sources above exemption levels, the regular performance of inspections covering both safety and security issues, the checking of all HASS records during inspections, mechanisms of financial security for the long-term management of HASS, the identification of strategic locations where orphan sources are likely to be found, the availability of emergency team 24/7, and the establishment of on-site emergency plan for HASS holder approved by the authority. Based on the analysis of weak points and points of attention, several recommendations are suggested to improve the implementation. They concern the current definition of HASS, the concept of undue delay for removal of disused sources from users’ premises, the immediate notification of any modification of HASS status, the type and frequency of tests to be performed on HASS, the arrangements to be made for the financial guarantees for management of disused HASS and orphan sources, the organization of recovery campaigns for orphan sources, and the training of personnel potentially confronted to orphan sources.

Analysis of HASS incidents in Europe reveals that very few incidents involving harmful radiation exposure and even fewer cases involving malicious intent have been reported. Criminal incidents made up only a minor percentage - less than 8 per cent - of all incidents reported to Interpol in 2007-2009. Discovery of radioactive sources or contaminated items in scrap metal is by far the most frequent incident encountered, occurring at scrap metal facilities and also at national borders.

Directive 2003/122/Euratom has on 6 December 2013 been repealed by the Directive 2013/59/Euratom (the new Basic Safety Standards Directive) [1], which incorporates the main provisions of the HASS Directive and harmonises them with the IAEA guidance on radioactive sources. The EU Member States have until 6 February 2018 to transpose the new BSS Directive into their national legislation.

1. Introduction

The HASS Directive [2] entered into force on 31 December 2003 and its legal enactment period ended two years later. Each EU Member State has designated a competent authority to carry out tasks in accordance with the Directive [3]. Article 14 of the Directive requires the Member States to report on its implementation before the end of 2010. The Commission is then required to provide an implementation report of the Directive to the European Parliament, Council and the European Economic and Social Committee.

All EU Member States have enacted the HASS Directive in their national legislation, but the review results indicate variable practices in the practical implementation of the Directive requirements. This is not surprising, since the number of HASS sources in the EU Member States range from only a few to several thousands. The quality of the reporting was also highly variable, illustrating the fact that some States have very advanced HASS control arrangements and administration, whereas some States fulfil the EU requirements with quite modest administration.

The implementation review was initiated by the European Commission in order to provide an overview of the situation in the EU on (1) the control of high activity sources in use, (2) the management of disused sources and (3) strategies for handling orphan sources. It is based on Member States' (EU-27) national HASS Directive implementation reports, questionnaires, interviews and fact-finding missions among the European HASS Competent Authorities.

2. High Activity Sealed Sources inventory in Europe

According to the data reported by EU Member States, the European inventory of HASS comprises about 30 700 HASS, of which 50% is represented by only Germany and France. Nine Member States have an inventory of less than 100 HASS. About 3 200 HASS holders are recorded in 24 Member States, of which 63% is represented by Germany, France, Poland and the UK. Typically there are 1-40 individual HASS per holder (in some cases multiple source devices are counted as one source).

Figure 1. Number of HASS and HASS holders in the EU member States

3. Implementation of Directive 2003/122/EURATOM 3.1. Overview

Figure 2 presents an overview of the HASS Directive implementation status in the 27 EU Member States. Results are presented as implemented (OK), require attention (PoA) and Difficulties in implementation (NOK). As can be deduced from the graph analysis, there is, in general, a good compliance with the HASS Directive requirements.

Figure 2. Overview of HASS Directive implementation in the 27 EU Member States (OK – Point of Attention PoA – Difficulties in implementation NOK)

3.2. Areas of inconsistent implementation of the Directive

Although in general compliant with the requirements of the HASS Directive, five subjects frequently show inconsistencies (point of attention) in implementation:

(1) The points for attention related to the legislative framework that are observed in 12 Member States are the following:

· Different activity levels than those set in the HASS Directive are considered to define HASS (for instance IAEA Category 3 levels).

· The report sent to the EC on the experience gained in the implementation of the HASS Directive is limited.

· The implementation of the definition of HASS in the national regulation is not compliant with the Directive. Indeed, several Member States which use the same HASS definition as that given in the HASS Directive consider in practice the actual activity levels of the source when implementing the national provisions. As such, a source whose activity has fallen below the high-activity levels of the Directive will be covered by the requirements for non-HASS.

(2) The main points for attention linked to the control of HASS by the holder are the following:

· No systematic leak tests of the HASS are performed by the HASS holders.

· The test programme carried out by the source holders is limited (only visual verification, no dose rate measurements).

(3) In ten Member States the documentation accompanying the HASS is not fully compliant with the requirements of the Article 7 of the Directive, which requests that the manufacturer provide a photograph of each manufactured source design type and of the typical source container. The holder shall ensure that each source is accompanied by written information, including photographs of the source, source container, transport packaging, device and equipment, as appropriate. Moreover, historical sources without an ID number are also present in some Member States.

(4) The main point of attention regarding the long-term management of HASS concerns the allowed period for storing disused HASS at the holder’s premises. The HASS Directive pleads for a transfer of each disused source without undue delay after it goes out of service. However, several Member States do not define in their regulatory regime the maximal period for storing disused sources at the holder’s premises, after which transfer becomes mandatory. In several Member States the financial guarantee for the safe long-term management of disused sources is uncertain. Finally it seems that HASS holders are not obliged to make adequate arrangements for the long-term management of disused HASS during the licensing process in one Member State, although it is required by article 3.2 (b) of the HASS Directive.

(5) The last subject requiring attention is the training and the information of workers potentially confronted with orphan sources. In four Member States such training is not organised, while in eight other Member States this training is either not required by regulation, or not given to all types of workers, or not carried out in all facilities at risk, or neither documented nor repeated.

3.1. Areas of difficult implementation of the Directive

Only one requirement is poorly implemented in about half of the Member States: the organisation of orphan sources recovery campaigns. Indeed, Article 9.4 of the HASS Directive requests that the Member States ensure that campaigns are organised, as appropriate, to recover orphan sources left behind from past activities. Organisation of these campaigns has turned out to be difficult in 14 Member States. However, several arguments were forwarded by the Member States to justify why such recovery campaigns are not organised. These main arguments are:

· HASS are under control and cannot become orphan sources.

· The inventory of HASS is complete and up-to-date.

· Detection means are installed at borders of the country.

· No orphan sources have been discovered yet.

· No recognised storage facility is available for the storage of recovered orphan sources.

· Recovery campaigns were organised before the HASS Directive was enacted.

In three Member States the requirements concerning record keeping (Article 5) have been difficult to implement because direct notification of modifications of the status of HASS to the authority is not always ensured.

3.2. Recommendations for improved implementation of the Directive

Based on the analysis of the HASS Directive enactment, several suggestions can be addressed to the Member States in order to improve its implementation:

(1) The need for organising systematic or dedicated orphan sources recovery campaigns should be assessed in those Member States which have not yet organised such campaigns. A first step towards assessing the need of a recovery campaign would be the analysis of historical records available at the authority and at the manufacturers/suppliers. During inspections at facilities where disused sources are more likely to be found, such as hospitals, universities, research centres, military sites, etc., more thorough investigations could be carried out at the premises, using measuring devices, to search for legacy sources possibly present on the site.

(2) To ensure the immediate notification of any modification of the HASS status, the national regulatory framework could define a maximum tolerated delay of a few days within which the relevant authority must be notified.

(3) Pending the transposition of the new EU Basic Safety Standards Directive, in which the HASS definition is revised, Member States using the definition of HASS as given in the current Directive should apply their national HASS provisions until the source is decayed below the exemption/clearance levels and not until the source activity has fallen below the high-activity levels.

(4) The type and frequency of tests to be performed by the HASS holders should be defined in the regulation or in a guidance elaborated by the regulatory body. These tests should be performed by a skilled person with adequate radiation protection competences. If a recognised radiation protection officer is not available among the HASS holder’s staff, the tests should be carried out by a recognised organisation, such as a Technical Support Organisation. In any case, the documentation recording the results of the tests on the HASS has to be checked by the authority during inspections to ensure that they were effectively performed and that the outcomes of the tests have been taken into account by the holder.

(5) The documentation accompanying the HASS should also be checked during inspections to verify its completeness as regards the requirements of the HASS Directive.

(6) To avoid the risk of loss of control of disused HASS stored at the holder’s premises, the maximum allowable time for storage before mandatory transfer could be laid down in national regulations. Compliance with this requirement should be checked during inspections and the necessary enforcement actions should be taken once non-compliance is observed. To avoid undesirable situations, adequate arrangements for the long-term management of disused HASS should be a prerequisite for authorisation for any practice.

(7) To ensure the proper training and information of persons in installations where orphan sources are more likely to be found or processed and in significant nodal transit points, national regulations should insist on the organisation of training sessions. The requirement should impose training courses for all types of installations at risk and for both categories of people (management and workers). Both the content and the frequency of the training sessions should be either defined or approved by the relevant authority. The training and information programme should include practical exercises, such as visual detection of sources and their containers, and actions to be taken on-site in the event of the detection or suspected detection of a source.

3.3. Best practices in implementation

Based on the analysis of the level of implementation of the HASS requirements in the 27 Member States, several best practices were identified. Examples of these are provided below.

(1) The licensing process is a key step in the management of HASS. Prior authorisation for any practice with a HASS specifies, for example, that adequate arrangements, including financial guarantees, have been made for the long-term management of the HASS, including cases in which the holder or supplier becomes insolvent or goes out of business. The long-term arrangement excludes the long-term storage of the disused HASS at the holder’s premises. The authorisation also describes the tests that will be performed by the holders on the HASS and their frequency, as well as the training sessions that will be organised for the exposed workers and the frequency at which they will be repeated.

(2) To ensure the prompt notification to the authority of any change with regard to the status of HASS, a maximum tolerated delay of few days is defined in national regulations enacting the HASS Directive.

(3) Announced and unannounced inspections are regularly carried out to check both the safety and security issues. The inspections aim at verifying all HASS records kept by the holder in order to check the correctness of the information notified to the authority. The documentation accompanying the source is also verified. During inspections, records relating to HASS testing and the training of the staff of HASS holders are verified. In addition to these documentary checks, visual inspections of the sources and measurements are performed by the inspectors, allowing them to assess the integrity of the source and its proper use.

(4) The HASS holder’s staff training programme is defined or approved by the authority and the frequency of repetition is set at a reasonable time interval (for instance, annually). The training courses are recorded and comprehension tests are organised. The training records are checked during inspections.

(5) The HASS Directive requires holders of sources to return each disused source to the supplier, place it in a recognised installation, or transfer it to another authorised holder without undue delay after it goes out of service, unless otherwise agreed by the competent authority. As “undue delay” is not precisely defined in the Directive, the period before mandatory transfer greatly varies among Member States, ranging from less than one year to several years or no defined time frame. The best practice consists of defining in a regulation a reasonable maximal period for removal of disused sources from users’ premises, e.g. max. 2 years. Take-back provisions alone do not guarantee the effective removal of disused sources from holders’ premises. Besides, financial arrangements, such as monetary deposits by the holders or suppliers are necessary. Such arrangements, financed by the source user community, are also available for the long-term management of disused HASS transferred to a recognised storage facility. Where the transfer of disused HASS to a recognised storage facility is one of the long-term management options, the Member State provides for access to a facility of sufficient capacity.

(6) The establishment and enactment of specific provisions regulating the security and physical protection of HASS is another good practice observed in several Member States. The security requirements defined are based on a graded approach, taking into account the risk posed by the sources.

(7) To avoid incidents with orphan sources, the Member State identifies strategic locations at which they are likely to be found or from which they can enter the country. Moreover, the regulatory authority imposes the installation of detection and monitoring equipment at these locations. Orphan source recovery campaigns are organised, especially in old or former installations where radioactive substances were or are still used. The financial burden for recovering and managing the orphan sources is not be supported by the community through the State budget but borne by the concerned source user communities. The response and alerting procedures for installations where orphan sources are more likely to be found are approved by the authority and exercises organised to test them. Managers and workers potentially confronted with an orphan source in all types of installations at risk are regularly trained in compliance with the requirements of the national regulation. The content of the training course is either defined or approved by the authority, which ensures that the sessions are documented and effectively given. The understanding of the trainees is evaluated. To increase the awareness of the persons potentially confronted with orphan sources the authority organises information sessions and develops guides, documentation, movies, posters, etc.

4. Implementation status in the Member States (EU-27) 4.1. Austria 4.1.1. Regulatory framework with respect to HASS 4.1.1.1. Regulatory authority

As Austria is a federal state the functions are divided between federal and local authorities. The regulatory authority with respect to HASS is the Federal Ministry of Agriculture, Forestry, Environment and Water Management, responsible for legislation and general administrative activities, operating of radiation protection registers, especially the radioactive source register, implementation of EU legislation, international contacts and information exchange on bilateral level, EU-level and international level.

4.1.1.2. Legislative framework

Austria has fully implemented the HASS Directive into the national legal framework.

The requirements of the HASS Directive are included into the Radiation Protection Act and the General Radiation Protection Regulation in force (Radiation Protection Act, BGBL Nr. 227/1967, last amendment BGBL I Nr.35/2012 and General Radiation Protection Regulation BGBL, II Nr. 191/2006, last amendment BGBL, II Nr. 76/2012). Beside the obligation to transpose the HASS Directive into national legislation, the federal authority is responsible for financial participation in the costs of recovering, managing and disposing of orphan sources (article 9), financial security of orphan sources (article 10), international cooperation (article 11) and report on experience (article 14). The local district authorities are responsible for authorization (article 3), transfers (article 4), records (article 5), and activities for safe and secure management of orphan sources (article 9), inspections (article 12) and penalties article 15.

The activity levels in the Austrian legislation for HASS follow Annex 1 of the HASS Directive. All sources with activity levels below the high-activity levels but above the exemption levels need authorization. This requirement of the General Radiation Protection Regulation was still in force before the transposition of the HASS Directive. A HASS stays covered by the HASS regulation until the activity level falls below the clearance levels. This is valid also for existing sources which would have been declared as HASS before the transposition of the HASS Directive.

4.1.2. Prevention and Deterrence 4.1.2.1. Authorization for practice with HASS

Before issuing an authorization for the use of HASS, all relevant issues are considered by the Regulatory Authority, including external accidents (fire, flooding…), emergency procedures and the long term management of the disused source. Authorization is only granted after all relevant information is received and has been judged by the Regulatory authority as being adequate. An authorization for a HASS has never been refused in Austria.

Regarding the topics before issuing an authorization a possible problem has been identified. In Austria disused radioactive sources should be returned to the manufacturer/supplier of the source. Usually this is subject to a contract between supplier/manufacturer and holder. In case of bankruptcy of manufacturer/supplier the source will stay under surveillance of the authority and the authority will take care for the long term management.

4.1.2.2. Records keeping and updating

The Federal Ministry of Agriculture, Forestry, Environment and Water Management is operating a national radioactive source database for sealed and unsealed sources within the Central Radiation Protection Register. Holders have the obligation to notify only sealed sources. The information on unsealed sources is only from transmitted quarterly reports.

The holder of a HASS has the obligation to record each source into this database electronically and immediately at the acquisition time. Therefore a holder gets protected access to the database. After saving an input into this database, each change is recorded in a log file to prevent misuse. All the stored information is available to the respective holder, the respective competent authorities as well as the operating Ministry. The stored information is available for inspection. During inspections the competent authority checks the match between the actual situation of the HASS and the information stored in the database and this for each HASS. All information following the Standard Record Sheet for Hass has to be recorded. The HASS register is a part of this source register, reflecting all recording requirements of the HASS Directive. Customs organizations and police organizations have access to the database on justified request. Any change in handling a source (transfer, disuse) is to be recorded into the database immediately.

4.1.2.3. National inventory

There is a central national HASS register in Austria. Typically the radio-nuclides are Co-60, Ir-192 and Cs-137 in medical facilities, Se-75, Sr-90, Cs-137 and Ir-192 in industry and Co-60 in the irradiation facility.

There is no HASS manufacturer in Austria. Correct identification and marking of HASS is verified by a TSO report (accredited testing centre) for all incoming sources: this is a requirement laid down in the General Radiation Protection Regulation.

4.1.2.4. Inspections and penalties

Periodic inspections (maximum every year) are organized by the competent local authorities. In case of an incident or any other suspicious situation, follow-up inspections are conducted. Inspections are usually announced and are performed by an inspection team. The inspection team is usually headed by a lawyer of the competent local authority and supported by a radiation protection expert and, if necessary, special security experts (inspectors). Requirements on technical background of the experts and their equipment are laid down during the accreditation process and verified by regular audits.

In case of non-respect of regulations, a system of administrative penalties is in place. These depend on the type of infraction and can range up to €50000. These penalties have not been applied in case of HASS up to now.

4.1.2.5. Control of HASS by the holder

The competent authority verifies regular performance of suitable tests by the holder to control good conditions of each HASS during inspection; this includes usually visual verification, leak tests and dose rate measurement. The frequency is laid down in the license.

The competent authority requests all information on the control measures implemented to prevent inadequate use, unauthorized access, loss or theft, fire protection etc., during the authorization process and verifies it during inspections.

4.1.2.6. Sources holders’ training

The content of the training program of HASS holder’s staff is defined by the authority as well as by the holder. The training material is prepared by the holder and the frequency is usually laid down in the license (minimum once a year). The performance and efficiency of training sessions is verified by checking training records during inspections. Management staff is trained in possible consequences of loss, theft or inadequate use or damage of sources.

The radiation protection officer is trained in radiation protection principles, specific requirements of safe management of sources, possible consequences of loss, theft or inadequate use or damage of sources, and notification to the competent authorities and emergency responses in case of an accident.

Usually the documentation accompanying the HASS includes source identification, information and photographs of the source design type, information and photographs of a typical source container, information and photographs of transport packing and information and photographs of device and equipment.

4.1.2.7. Identification and marking of HASS

HASS need to be systematically accompanied by the necessary documentation with all relevant information. There are four historical sources without ID on the Austrian territory.

4.1.2.8. Transfers of HASS

Each transfer of HASS needs authorization and has also to be recorded in the central source database. Before the transfer of a HASS, the holder ascertains that the recipient holds appropriate authorization by request of copy of the authorization from the recipient.

The competent authority is informed of individual transfers of HASS by issuing an authorization/permit to the holder for the transfer, as well as by issuing an authorization/permit for the transport. In case of international import (from non EU- country) an import permit is requested. There is no evidence of loss or out of control incidents due to unrecorded transfers.

4.1.2.9. Long-term management of disused HASS

The national regulatory framework does not define a limited useful life for HASS. Currently an authorization is only granted if the long-term management route is already specified and planned.

The country’s policy on disused sources gives priority to returning the disused source to the supplier. Another possibility is transfer to another authorized user. If this would not be possible, the disused sources should be considered as radioactive waste and be transferred to the national authorised waste treatment and storage facility or an adequate facility. The actual situation of disused HASS corresponds to this policy. In some seldom occurring cases disused sources are stored at the holder’s premises. The national waste treatment and storage facility is also encouraged to possibly send back disused sources to the manufacturer.

The long-term management of disused sources is funded through take-back provisions incorporated in the supply contracts and through a fund set up by Holders.

4.1.3. Detection 4.1.3.1. Detection of orphan sources

Metal scrap yards, scrap recycling facilities, metallurgic industry and conventional waste management facilities are locations in Austria where routine monitoring for orphan sources is performed. Necessary equipment is provided by the respective companies, as e.g. scrap yards have to certify that supplied scrap is free of radioactive content. There is no permanent monitoring for radiation sources at the state’s borders. Radiation detection equipment is also available in the radiation monitoring labs and for the intervention teams e.g. specialised police units.

4.1.3.2. Campaigns for orphan sources recovery

In the late eighties and early nineties of the last century campaigns have been organized to investigate schools, universities and research institutes as well as in hospitals with radium irradiation facilities with the aim to recover disused sealed and unsealed, solid and liquid radioactive material and orphan sources. These activities have been financed by the competent authorities and the recovered radioactive material has been transferred to the waste treatment and storage facility. Currently a campaign for retrieving remaining sources from past practices, primarily concerning production and selling of radium sources and devices using radium in Austria in the first decades of the 20th century, is ongoing. These activities are financed by the competent Ministry.

4.1.3.3. International cooperation and information exchanges

Austria is actively participating in international cooperation and information exchange, mainly through the established IAEA channels. The country is contributing to the IAEA Incident and Trafficking Database (ITDB). The responsible authority is the Federal Ministry of economic Affairs.

4.1.4. Preparedness and Response 4.1.4.1. Emergency plans and procedures

Austria has a general emergency response plan in operation, also applicable in the case of radiological emergencies. However, HASS or orphan sources are not specifically addressed in the plan. HASS holders on the other hand do require an on-site emergency response plan, which needs to be established including the local municipality and local, maybe also regional, Fire Brigade and Rescue Service.

In each of the 99 Austrian districts the district police station is equipped with adequate measuring equipment and a sufficient number of policemen is educated and trained in managing recovered and/or supposed radioactive material. A similar situation exists with respect to the fire brigades and rescue services.

The number of educated and trained persons is adequate to guarantee interventions 24/7. In addition, dedicated vehicles (mobile laboratories) are available as well as helicopters with special equipment to detect radioactive material. Depending on the emergency situation the regional emergency centres or the federal emergency centre coordinate the activities. If necessary, experts from TSO’s are also involved for special duties, like radiological assessment, source transport and final contamination control. Contact points are the provincial alarming centres and the federal alarming centre.

4.1.4.2. Training and information of persons potentially confronted with an orphan source

Within the national emergency plan all required actions are attributed to responsible organisations. All activities are coordinated, depending on the situation, on provincial level and/or federal level.

A quite extensive and adequate training and information plan is mandatory for all people who could potentially be confronted to orphan sources at both worker and management levels. The training for the workers is more detailed than the training for the management. These training sessions are to be repeated every 5 years. There is a comprehension test organised. The emergency trainings include also practical exercises on recovering, identification and management of radioactive sources.

4.2. Belgium 4.2.1. Regulatory framework with respect to HASS 4.2.1.1. Regulatory authority

The primary Regulatory authority in the field of safety and security of ionising radiation sources in the country is the Federal Agency for Nuclear Control (FANC), which is an independent agency under the tutelage of the Minister of Interior. Its main functions related to HASS include licensing, inspection and international collaboration. These functions are not limited to HASS, but cover all ionising radiation sources. This regulatory authority is supplied by recognised radiation protection control organisations that perform on a regular basis controls in the installations using ionising radiation sources.

The National Institute for Radioactive Waste and Enriched Fissile Materials (NIRAS-ONDRAF) is the national manager of radioactive waste in the country. This institute is responsible for the financial aspects of radioactive wastes, including HASS and orphan sources.

4.2.1.2. Legislative framework

The legislative framework in the country is based upon the Law laying down the Protection of the Public and the Environment against the hazards of Ionising Radiation and concerning the Federal Agency for Nuclear control of 15th April 1994. One main regulation foresees in its implementation:

· Royal Decree laying down the General Regulations on the Protection of the Public, the Workers and the Environment against the hazards of Ionising Radiation (20th July 2001);

In addition to this, several other royal decrees regulate specific aspects. These include:

· Royal Decree laying down the Nuclear and Radiological Emergency Plan for the Belgian Territory (17th October 2003);

· Royal Decree regulating the Import, Transit and Export of Radioactive Material (24th March 2009);

· Royal Decree concerning the Detection of Radioactive Material in certain Material and Waste Streams and concerning the Management of Installations sensitive to Orphan Sources (14th October 2011).

· This regulatory framework is completed with a number of decisions by the Agency. The most relevant to the field of HASS and orphan sources is:

· Decision containing guidelines to follow when Detecting or finding an Orphan Source in Royal Decree concerning the Detection of Radioactive Material in Installations of the Non-nuclear Sector prone to Orphan Sources (3rd November 2011).

This framework regulates the use of all types of radiation sources, including HASS. The HASS Directive is fully implemented into the Belgian regulations. The same definition and related radiological criteria are being used for defining HASS as those used in the Directive.

The main differences between HASS and non HASS are to be found in records keeping, identification and marking and reporting. Requirements for users, authorisation regime, inspection, training and financial security are similar for HASS and non HASS.

4.2.2. Prevention and Deterrence 4.2.2.1. Authorization for practice with HASS

Before issuing an authorization for the use of HASS, all relevant issues are considered by the Regulatory Authority, including external accidents (fire, flooding …), emergency procedures and the long term management of the disused source. Authorization is only granted after all relevant information is received and has been judged as being adequate by the Regulatory Authority. FANC has never had to refuse an authorisation for HASS.

4.2.2.2. Records keeping and updating

All HASS holders are required to maintain records of the HASS under their responsibility. A written copy and/or an electronic copy of these records are to be sent to the Regulatory authority at the time of acquisition of the source and then on a yearly basis. A maximum tolerated delay of 30 calendar days is defined in the regulation to notify any modification. The authorization for a transfer of a HASS must be obtained before the actual movement of the source (prior authorization). Records sent to the authority are often incomplete or contain inaccurate information. To solve this, FANC has recently made the qualified expert of the installation explicitly responsible for transmitting on time the complete and correct information.

4.2.2.3. National inventory

The information received through these records is used to maintain an electronic national inventory of HASS. The Regulatory authority supposes that there are a few old sources in the country that are not recorded in this database. The HASS inventory does not separate the HASS by use. Hence it does not easily allow having an idea of the number of HASS in each sector of activity. Together with the HASS inventory, the FANC maintains a database of the authorizations of the holders of all sources of ionising radiation.

4.2.2.4. Inspections and penalties

During inspections, a systematic verification between the records in possession of the Regulatory authority and the actual situation at the licensee is performed for all HASS. Inspections are performed by the Regulatory authority (in relation with safety and basis security issues) and by 2 recognised TSO’s (in relation with safety issues only). In Belgium, non-proliferation verifications remain limited to nuclear materials and are hence not considered for HASS that are not considered nuclear material under safeguard.

As a general rule, controls by TSO are announced to the licensee and come with a frequency of 4 per year whilst Regulatory Authority’s inspections are annually planned. In addition, unannounced inspections take place as well as inspections organised as part of follow-up actions after incidents or accidents.

In case of non-respect of regulations, a system of penal and administrative penalties is in place. These penalties depend on the type of infraction, but are not specifically related to HASS. They can range from €500 to €1000000 or imprisonment between 3 months and 2 years. The system of penalties has not been used yet.

4.2.2.5. Control of HASS by the holder

Regular testing by the licensee of safety and security performances are required by the Regulatory Authority. Leak tests are performed yearly. The reports on the results are not systematically transferred to the Regulatory Authority, but systematic verification of the execution of the tests is performed during inspection.

4.2.2.6. Sources holders’ training

HASS holder’s staff requires training, which is defined and delivered by the holder. Training sessions are given annually to the exposed workers, but a comprehension test is not always organized. These trainings cover all relevant topics and are recorded and documented by the holder and the Regulatory authority verifies the training records during inspections. Non-exposed workers receive only training on the radiation protection principles.

4.2.2.7. Identification and marking of HASS

There is only one HASS manufacturer in Belgium. There is no control by the Belgian authorities on the correct identification and marking of the HASS produced. HASS need to be systematically accompanied by the necessary documentation. This documentation contains only the source ID and photographs of the source design type. Some old sources for research have no ID in Belgium.

4.2.2.8. Transfers of HASS

In case of transfer of HASS, the Regulatory authority is informed of the transfer through the cross-check between the prior-authorisation request and the records of the holder and through issuing an authorisation/permit for the transport. The holder transferring a HASS also needs to verify that the recipient holds a valid authorisation for the possession of the source. This is done by requesting a copy of the authorisation to the recipient. For international transfer out of EU, an acknowledgement receipt of the source is requested to the new recipient. No cases where HASS got out of control during transfer are known to the Regulatory Authority.

4.2.2.9. Long-term management of disused HASS

With respect to the long-term management of HASS, the regulations do not define specific criteria for recommended working life or for sealed source performance. The holder of HASS is forced to make adequate arrangements for the long term management of HASS. The country’s policy on disused sources gives priority to reuse of the source by another holder. If this would not be possible, returning the disused source to the supplier would be the preferred alternative to treating the disused source as radioactive waste and transferring it to an authorised waste treatment or storage facility. The actual situation of disused HASS however is such that reuse is rarely the case, so that the first solution would be return to the supplier, followed by treatment as radioactive waste. There is a maximal period of 5 years without use during which the holders can store a disused source at his premises. After that period, the HASS has to be considered as radioactive waste and transferred within 6 months to the national authorised storage facility for radioactive waste, operated by Belgoprocess in Dessel. This facility accepts disused HASS and its foreseen capacity is judged to be sufficient.

Situations with sources without a long-term management have already occurred, typically in Universities and in relation with bankruptcy of the holder or with orphan sources. These cases have been dealt with through funding by a nationally installed insolvency fund based on contributions from the radioactive waste producers and managed by the national organisation for radioactive waste management NIRAS/ONDRAF.

4.2.2.10. Security measures

With respect to security measures (fences, video surveillance, access control, locks, security staff, etc.), a national regulation is in preparation, but has not yet entered into force.

4.2.3. Detection 4.2.3.1. Detection of orphan sources

In cooperation with the stakeholders and the environmental administration of the three Belgian regions, the FANC has identified material flows, treated by the waste recycling and processing industries that risk containing orphan sources. These flows have been matched against the EC waste classification codes and are considered “orphan source sensitive flows”. Non-nuclear industries processing these flows are considered as “orphan source sensitive”. All the related facilities will have to apply minimum requirements for personnel training, vigilance measures and reaction to the discovery of a source. A reaction procedure has been set up and will also be made compulsory. Amongst the orphan source sensitive facilities, some have a higher probability of being confronted with orphan sources. Consequently, those facilities will have to comply with the obligation of systematic and automatic screening of all incoming orphan source sensitive material flows. The regulations specify the minimal requirements for the detection equipment to be foreseen. Next to these orphan sensitive industries, borders, harbours and transit hubs are considered strategic locations for detecting orphan sources.

4.2.3.2. Campaign for orphan sources recovery

Recovery campaigns have been organised, e.g. in schools, hospitals and pharmacies. These are not foreseen in the regulations, but are organised in function of needs and requests, in collaboration between the FANC, NIRAS and the recognised TSO. They are funded through the ‘polluter pays’ principle, using the scaling advantage for reducing the costs. In case the polluter cannot be identified, the insolvency funds of NIRAS, supplied through radioactive waste producers, will bear the costs.

4.2.3.3. International cooperation and information exchanges

Belgium is actively participating in international cooperation and information exchange, mainly through the established IAEA channels. The country is contributing to the IAEA Incident and Trafficking Database (ITDB) for over 10 years. Over the previous 10 years, Belgium made 3 notifications to the IAEA, on theft, loss and discovery of radioactive sources and it has been informed regularly by other countries on events involving radioactive material.

4.2.4. Preparedness and Response 4.2.4.1. Emergency plans and procedures

Belgium has a general emergency response plan in operation, also applicable in the case of radiological emergencies. However, although applicable, HASS or orphan sources are not specifically addressed in the plan. HASS holders also require an on-site emergency response plan, which needs to be approved by the qualified expert of the installation. The orphan source sensitive facilities do not require an emergency response plan, but require a vigilance procedure and a reaction procedure, in line with the applicable regulations.

In case of emergencies involving HASS or orphan sources, also in the orphan source sensitive facilities, the Regulatory authority has an emergency team available to intervene 24/7. This team is composed of 2 persons and has full radiological intervention equipment available, either directly, either through partners (e.g. mobile laboratories). The team can also call specialised companies, like TSO, transport companies, etc. Up to now the national emergency plan has not been initiated in Belgium in relation to situations involving HASS or orphan sources. The reaction scheme for orphan source sensitive facilities foresees a notification within 24h through a dedicated e-mail address. This system has been activated 217 times over the past 10 years.

4.2.4.2. Training and information of persons potentially confronted with an orphan source

Within the national emergency plan all required actions are attributed to responsible organisation. An extensive and adequate training and information plan is mandatory for all people who could potentially be confronted to orphan sources both at the level of the workers as at the level of the management. These training sessions are repeated yearly. There is no comprehension test organised. The emergency trainings include also practical exercises on identification of sources of ionising radiation.

4.3. Bulgaria 4.3.1. Regulatory framework with respect to HASS 4.3.1.1. Regulatory authority

The competent organisation in relation with HASS management is the Nuclear Regulatory Agency (NRA) and its inspections services. The Head of the NRA is the central authority and is designated to implement government regulation on the safe use of nuclear power and ionising radiation, as well as safe radioactive waste and spent fuel management. Military sources are also under the supervision of the NRA.

4.3.1.2. Legislative framework

The HASS Directive is currently fully transposed in the national regulatory framework. The legislative framework in the country is based on the following regulations, amended and supplemented with HASS requirements.

· REGULATION ON RADIATION PROTECTION DURING ACTIVITIES WITH SOURCES OF IONISING RADIATION (Promulgated in “State Gazette”, No. 74, August 24th, 2004, amended and supplemented SG No. 74/08.09.2006, effective 1.01.2007, amended SG No. 46/12.06.2007, effective 12.06.2007) (This regulation was in force for all radioactive sources before the transposition of the HASS Directive.)

· ACT ON THE SAFE USE OF NUCLEAR ENERGY (ASUNE) - Promulgated in the State Gazette No 63/2002, last amended and supplemented SG 80/2010 Regulation on the Procedure for Issuing Licenses and Permits for Safe Use of Nuclear Energy (Promulgated in the State Gazette No. 41/18.05.2004 Amended SG No. 78/30.09.2005)

· REGULATION ON THE TERMS AND PROCEDURE FOR DELIVERY OF RADIOACTIVE WASTE TO THE RADIOACTIVE WASTE STATE-OWNED COMPANY (Promulgated in SG, No.64 of 23 July 2004) Regulation for the procedure for assessment, collection, spending and control of the financial resources and definition of the amount of contributions due on the “Radioactive waste” Fund

· REGULATION ON EMERGENCY PLANNING AND EMERGENCY PREPAREDNESS IN CASE OF NUCLEAR AND RADIOLOGICAL EMERGENCIES (Adopted: Council of Ministers Decision No. 133 of 29 November 2011, Promulgated in the State Gazette 94/2011) National Emergency Plan - special procedure concerning orphan sources

· REGULATION OF THE CONDITIONS AND PROCEDURE FOR NOTIFICATION OF THE NUCLEAR REGULATORY AGENCY ABOUT EVENTS IN NUCLEAR FACILITIES AND SITES WITH SOURCES OF IONISING RADIATION. Adopted with CM Decree № 188, July 30, 2004, Promulgated in State Gazette 71/2004, amended SG issue 46/2007)

4.3.2. Prevention and Deterrence 4.3.2.1. Authorization for practice with HASS

The authorisation for practice with HASS is done according to the following regulations:

· REGULATION ON THE PROCEDURE FOR ISSUING LICENSES AND PERMITS FOR SAFE USE OF NUCLEAR ENERGY (Promulgated in the State Gazette No 41/2004, Amended SG No. 78/2005)

· REGULATION ON RADIATION PROTECTION DURING ACTIVITIES WITH SOURCES OF IONISING RADIATION (Promulgated in “State Gazette”, No. 74/2004, amended and supplemented SG No. 74/2006, amended SG No. 46/2007)

· REGULATION ON PROVIDING OF PHYSICAL PROTECTION OF NUCLEAR FACILITIES NUCLEAR MATERIAL AND RADIOACTIVE SUBSTANCES (Promulgated in State Gazette No. 77/2004, amended SG No. 96/2005, supplemented SG No. 44/2008).

All topics are being taken under consideration: justification of use; responsibilities; staff competencies; adequacy of the source with respect to its utilisation; available documentation and procedures for work and maintenance; emergency procedures and communication links; adequate arrangement for long term management of the disused sources; adequate financial security aspects for long term management of the disused sources; control measures to prevent inadequate use, unauthorised access, loss or theft of the HASS and control measures have been implemented to prevent damage of HASS by fire, flooding, etc.

The maximum licence period for the use of HASS is 10 years. On few occasions authorization for the use of a HASS has been refused because some requirements for radiation protection, safety and security of HASS were not met.

4.3.2.2. Records keeping and updating

HASS holders are required to keep records of all HASS under their responsibility in accordance with ASUNE and using the forms given in Annex II of the Directive. The HASS holder provides NRA with the recorded information periodically (12 months). Moreover, the information is provided at the acquisition time, when the holder no longer holds/uses the source and when the holder no longer uses any other source. When the sources are stolen or lost, the information should be provided immediately to the Ministry of Interior, the NRA and the Ministry of Public health. The maximum tolerated delay to provide the information is three months after the end of the year.

4.3.2.3. National inventory

The NRA maintains National Register of the Radioactive Sources that comprises all sealed sources category 1 to 5 - including HASS and other sources. The National Register is based on the IAEA recommendations given in the Code of Conduct (2004). It comprises all sealed and unsealed sources as well as X-ray devices and accelerators that are under regulatory control.

The information requested in the standard record sheet is in agreement with Annex II of the HASS directive. The register of HASS is available to police and to customs organisations, respectively. Holders’ records are available for inspection by competent authorities. During inspections, the Authority checks the match between the actual situation of the HASS and the information recorded by the Holder, according to the Guidance for inspections approved by the NRA Chairman. The verification is made randomly on a certain number of HASS and at least for all the HASS every 12 months.

4.3.2.4. Inspections and penalties

20 inspectors of the NRA are in charge of the inspections of HASS holders for the aspects related to safety, security and radiation protection. Inspections are organised periodically (announced), randomly (unannounced) or as follow-up in case of an incident or any other suspicious situation.

The inspectors are trained on confrontation with a source; visual detection of sources and containers; requirements for safe management of sources; possible consequences of loss, theft or inadequate use or damage of sources; procedures for prompt notification to the Authority and emergency responses in case of accident. The standard equipment of inspectors consists of individual dosimeters; contamination detectors; list and pictures of typical sources and containers; specific tools are available (shielding, long arm pliers, etc.). The inspection is paid by an annual tax linked to the authorisation.

The Penalties are regulated by the ACT ON THE SAFE USE OF NUCLEAR ENERGY (Promulgated in the State Gazette No 63/2002, last amended and supplemented SG 80/2010) which includes special Chapter Eleven ADMINISTRATIVE PENALTY PROVISIONS (Section I:ADMINISTRATIVE LIABILITY and Section II: ADMINISTRATIVE ENFORCEMENT MEASURES).

4.3.2.5. Control of HASS by the holder

The inspection for leaks of HASS is a specific requirement for Licensees. Every licensee shall ensure control on the conditions of used or stored HASS by carrying regular leak test with frequency determined by the NRA. A qualified personnel has to be appointed for control and recording of HASS.

4.3.2.6. Sources holders’ training

A comprehensive system for training and informing people working with high activity sources has been implemented in Bulgaria. The definition of the training program of the HASS holder staff is done according to the REGULATION ON THE TERMS AND PROCEDURE FOR OBTAINING OF VOCATIONAL QUALIFICATION AND ON THE PROCEDURE FOR ISSUING OF LICENSES FOR SPECIALISED TRAINING AND OF INDIVIDUAL LICENSES FOR USE OF NUCLEAR POWER (Promulgated in "State Gazette", No. 74/2004, amended SG No. 46/2007).

The training sessions are recorded but no comprehension test is organized. The performance and efficiency of the training sessions is verified by checking training records during inspection and through regular reporting by the holder. The categories subjected to training are the management staff, the radiation protection officer and the exposed workers. The NRA published on its website a number of manuals, textbooks, monographs and other radiation protection-related training materials to help people who work in an ionisation radiation environment.

4.3.2.7. Identification and marking of HASS

The correct identification and marking of the HASS by the manufacturer/supplier is not currently verified by the Regulatory Authority. The recommended working life is given in the certificate of the source. Bulgaria does not produce any radioactive sources.

4.3.2.8. Transfers of HASS

On average, about 30 to 40 high-activity sources are imported each year in Bulgaria. Most of them are for gammagraphy (iridium-192, selenium-75) and more rarely for gammatherapy (cobalt-60) and brachytherapy or for metrology and technological control devices (caesium-137, americium-241, iridium-192, etc.).

Permit holders (importers) and licensees (users) inform the NRA of the movement and location of the respective ionising radiation sources. Licensees are required to notify the NRA of all new circumstances and events relating to the change of ownership, location and of any accident or emergency with ionising radiation sources. In the event of failure to notify the authority, the administrative penal provisions set out shall be applied.

The NRA issues an authorisation/permit for the transport and issues an authorisation to the Recipient in case of a National transfer. Additionally, the NRA is informed of individual transfer of HASS by the National Authority of the Recipient’s country in case of an International transfer.

4.3.2.9. Long-term management of disused HASS

According to the design documentation of the sources, the NRA defines a limited useful life for HASS of 10 years of safe operating lifetime. Once the safe operating lifetime is ended, it should be treated as radioactive waste. If the holder still wants to use the source it is its obligation to re-test the source for a new working period. Reuse has to be authorized by the NRA.

The preferred strategy for the long-term management is the return to the supplier of the disused sources but represents more the exception rather than the rule although sources import is allowed on condition of their guaranteed return to the manufacturer upon termination of use. The solutions actually implemented are the transfer to authorised radioactive waste treatment/storage. Sources are declared as radioactive waste to the “State Enterprise Radioactive Waste” (SERAW) which has been licensed by NRA to carry out activities relating to the safe management of radioactive waste. The facility used at present is not adapted to the potential amount of disused sources; therefore the construction of a new authorized facility is planned. Disused source storage at the user’s premises is allowed only on a case by case basis.

The long-term management of disused HASS is funded by provisions incorporated in the supply contract and by the fund pre-paid by the Holder to the State or competent authority.

4.3.2.10. Security measures

According to REGULATION On Providing of Physical Protection of Nuclear Facilities Nuclear Material and Radioactive substances (Promulgated in State Gazette No. 77/2004, amended SG No. 96/2005, supplemented SG No. 44/2008), the minimum compulsory security requirements for HASS are:

• holder’s premises during use: fences, video surveillance, access control, security staff;

• holder’s premises during storage: fences, video surveillance, access control, security staff, locked premises, sources with a lock;

• place of use for mobile sources: fences, security staff, sources with a lock;

• authorized radwaste storage facility: fences, video surveillance, access control, security staff, locked premises, sources with a lock, fire detection.

4.3.3. Detection 4.3.3.1. Detection of orphan sources

The strategic locations identified to detect orphan sources are metal scrap yards and recycling facilities; metallurgical industries; conventional waste management facilities, borders/customs and harbours; airports. The detection equipment is of portable type and/or portals. The controls are voluntary with exception of the conventional waste management facilities where the controls are mandatory.

4.3.3.2. Campaign for orphan sources recovery

The regulatory framework does not ensure that campaigns to recover orphan sources are organised and no budget is assigned to that. Nevertheless some recovery campaigns have been organised by NRA and SERAW. The costs related to recovery and LT management of orphan sources is supported by State and source holders.

4.3.3.3. International cooperation and information exchanges

Bulgaria contributes to the IAEA Incident and Trafficking Database.

4.3.4. Preparedness and Response 4.3.4.1. Emergency plans and procedures

Bulgaria has a national radiological emergency response plan in place with relation to HASS and orphan sources. It has been approved by the competent Authority (NRA). Response procedures in the event of emergencies with orphan sources are annexed to the National Emergency Plan. These documents regulate the responsibilities for cooperation of interested departments and reduce the potential overlapping of role. This is particularly the case for all communications and instructions to the public.

There is an emergency team available to intervene 24/7 in case of emergency.

There are compulsory emergency preparedness and response requirements for the HASS holders which have to be approved by the authority. Similar requirements are available for facilities where orphan sources are likely to be found.

4.3.4.2. Training and information of persons potentially confronted with an orphan source

The NRA organises courses and carries out training on the application of the new legislation in the field of emergency planning and response for employees of the MIA, SANS, General Department “Border Police” and State Agency Customs as well as for companies working with scrap metal. These training course are however not obligatory according to the regulations, neither documented nor regularly repeated.

4.4. Cyprus 4.4.1. Regulatory framework with respect to HASS 4.4.1.1. Regulatory authority

The Regulatory authorityis the Radiation Inspection and Control Service (RICS) of the Department of Labour Inspection, Ministry of Labour and Social Insurance.

The use of ionising radiation in the country is mainly dedicated to applications in medicine, and some applications in industry, construction and education/research. Most of the high-activity sealed sources falling within the scope of the Directive are disused and kept in a dedicated authorised safe storage catering for all disused sources in the country.

All practices involving the use of high-activity sealed sources and all premises, where exposure to ionising radiation occurs or may occur, need prior authorisation and are regularly inspected by RICS to verify compliance with the legislation requirements.

The obligations of the licensees include risk assessment, training of the staff, preparation of emergency preparedness and response plans, maintenance of equipment, sources and containers, adequate management of waste and disused sources, keeping of suitable records of all sources in their possession, appropriate testing of both the sources and the equipment, and prompt notification of the authority after an incident or accident resulting from unintentional exposure of workers or members of the public.

There is a system for the detection of orphan sources in places where these could be possibly encountered, such as in large metal scrap yards, customs and major ports, where radiation monitoring equipment has been installed and is in use. So far, there has been a number of campaigns for the identification or recovery of orphan sources from past activities.

4.4.1.2. Legislative framework

The legal framework consists of

· “The Protection from Ionising Radiation and Nuclear Safety Laws of 2002 to 2011” promulgated in 2002 and amended in 2009 and 2011 and relevant sets of Regulations issued under these Laws.

· The Council Directive 2003/122/EURATOM of 22 December 2003 on the control of high-activity sealed radioactive sources and orphan sources was fully transposed into the national legislation as a set of Regulations under the above mentioned Laws with the title “The Protection from Ionising Radiation (Control of High-Activity Sealed Sources and Orphan Sources) Regulations of 2006” (P.I. 30/2006, OJ 4075, 31.01.2006).

A source is excluded from the regulatory control when its activity level is below the exemption level specified in Directive 96/29/EURATOM.

A source with high activity, which classified it as a HASS according to the Directive, whose activity has been reduced below the HASS specified levels, when the HASS Directive was transposed, is covered by the provisions and amendments of the Protection from Ionising Radiation and Nuclear Safety Laws of 2002 to 2011. The Protection from Ionising Radiation (Control of High-Activity Sealed Sources and Orphan Sources) Regulations of 2006 specify which sources are classified as HASS and provide a special form to be completed for the record keeping of HASS sources. They also impose some additional requirements for the owners and users of HASS sources. The licensing procedure is the same for all sources.

4.4.2. Prevention and Deterrence 4.4.2.1. Authorization for practice with HASS

Before issuing an authorisation, all relevant factors are being taken under consideration: justification of use; responsibilities; staff competencies; adequacy of the source with respect to its utilisation; available documentation and procedures for work and maintenance; emergency procedures and communication links; adequate arrangement for long term management of the disused sources; control measures to prevent inadequate use, unauthorised access, loss or theft of the HASS and control measures to prevent damage of HASS by fire, flooding, etc. Until present, RICS has not refused an authorisation.

4.4.2.2. Records keeping and updating

HASS holders are required to keep records of all HASS under their responsibility. A HASS holder provides to RICS the recorded information at the acquisition time, every 12 months and also whenever such information is requested by the RA. No notification needs to be immediately done after modifications of the status of the HASS (in use, disused, transferred …).

4.4.2.3. National inventory

The recorded information is kept in a national inventory of authorised HASS holders and their HASS. The information is provided in writing (in paper or electronic form) and the data is processed in an electronic database (RAIS). The registry of authorised HASS holders is available to the customs authorities and the police at their request.

4.4.2.4. Inspections and penalties

Inspectors of RICS are in charge of the inspections of HASS holders in the fields of Safety, Security and Non-proliferation. The inspections are carried out periodically (announced or unannounced) and as a follow-up action in case of incidents. The frequency of inspections for each holder depends on the type of sources, the risk involved, their mobility, results of previous inspections etc. (Graded Approach). The inspections are funded directly by the Government.

The penalties in case of breaches are a maximum of €34.500 fine, two years imprisonment or both penalties simultaneously. No penalties have been imposed yet.

4.4.2.5. Control of HASS by the holder

The regulatory authority verifies the regular performance of suitable tests (visual verification, leak tests, dose rate measurement) by the holder to control the good conditions of each HASS during inspections and by receiving the tests results.

4.4.2.6. Sources holders’ training

The content of the training programme is defined by the HASS holder and approved by the RA, while the training sessions are given by the holder and by any training organisation approved by the RA. The training sessions are recorded but no comprehension test is organized. The performance and efficiency of the training sessions are carried out by checking training records during inspections and by regular reporting as required to the RA. The personnel categories subjected to training are the management staff, the radiation protection officer and the potentially exposed workers.

4.4.2.7. Identification and marking of HASS

The documentation accompanying a HASS includes the source identification, on the source or on the container, information and photographs of the source, container and transport packaging. To the knowledge of the authority, there are no HASS in the territory without identification number. No working life is recommended for the use of HASS.

4.4.2.8. Transfers of HASS

The authority is informed of individual transfer of a HASS by issuing a permit to the holder for the transfer and by issuing authorisation for both the transport of the source and the recipient in case of national transfer. In case of international transfer, the authority is informed by the national RA of the recipient country. The holder ascertains that the recipient holds the appropriate authorisation by asking for a copy of it. Cyprus has not encountered up to now situations with sources out of control due to unrecorded transfers.

4.4.2.9. Long-term management of disused HASS

The national regulatory framework does not specify a limited useful life for HASS. Authorisation for holding HASS is issued only if the long-term management route is already specified and planned. The applied strategy for the long-term management is the return to the supplier of the disused sources. The import of a new source is nowadays conditioned to its re-export after use. “Take-back” provisions have to be incorporated into the supply contract.

The storage at the holder’s premises seems also to be a solution, which could be implemented for a certain period of time, until export. An authorised storage facility is available at national level with limited capacity for temporary storage only.

4.4.2.10. Security measures

The security requirements for HASS foresee fences, recorded control access, locked premises and locked sources as well as fire detection. Video surveillance is not considered necessary.

4.4.3. Detection 4.4.3.1. Detection of orphan sources

A threat assessment concerning orphan sources has been performed at national level by the authority, giving as strategic locations for finding orphan sources metal scrap yards, borders/customs, harbours and airports. All of these sites are currently monitored or equipped with radiation monitoring portals, scanners and other portable monitoring equipment. The use of detection equipment is compulsory in metal scrap yards, ports and airports. The equipment used is approved by the authority, which has also various types of sensitive equipment for the detection of orphan sources.

4.4.3.2. Campaign for orphan sources recovery

Starting from systematic analysis of historical records available at the authority, in industries and other workplaces, the authority has organised a number of campaigns for the identification or recovery of orphan sources from past activities, such as from a decommissioned phosphoric acid plant, and other practices in medicine, industrial radiography, tobacco industry, brewery, copper mining, and brick/ceramics plants.

All HASS in Cyprus are accounted for. Training and information has been provided to all stakeholders involved.

4.4.3.3. International cooperation and information exchanges

Cyprus is being informed by foreign countries about sources that have been stolen, lost, discovered, etc. Cyprus participates in the IAEA Incident and Trafficking Database but until present no cases have been reported.

4.4.4. Preparedness and Response 4.4.4.1. Emergency plans and procedures

Cyprus has a national radiological emergency response plan in place to deal with orphan sources and HASS. The emergency response plan has not been initiated up to now because no orphan sources were detected or incidents involving HASS occurred. There are compulsory emergency preparedness and response requirements for the HASS holders and users as well as for operators of institutions where orphan sources are most likely to be found. These requirements as well as the procedures must be approved by the regulatory authority.

There is a unique contact point designated in case of detection of an orphan source and there are both a general and a dedicated emergency call numbers. Information campaign is restricted to people and institutions likely to be confronted with orphan sources and to emergency services.

The authority emergency team is available 24/7 in case of emergency. The equipment available is composed of measurement devices, individual protection equipment, shielding containers and decontamination material. The emergency response plan has not been initiated up to now because no orphan sources were detected or incidents with HASS occurred.

4.4.4.2. Training and information of persons potentially confronted with an orphan source

The personnel potentially confronted with orphan sources are trained and the courses are obligatory according to the regulations. The training is addressed to workers and managers in the emergency and transport sectors and in the facilities. The courses are documented and regularly repeated. The training sessions include practical exercises depending on the audience but no comprehension test is organised.

4.5. Czech Republic 4.5.1. Regulatory framework with respect to HASS 4.5.1.1. Regulatory authority

The regulatory body responsible for HASS in the Czech Republic is the State Office for Nuclear Safety (SÚJB). The SÚJB is a regulatory body responsible for governmental administration and supervision in the fields of uses of nuclear energy and radiation and of radiation protection. Duties relevant to HASS include particularly:

· Radiation protection and emergency preparedness of workplaces handling ionising radiation sources, including HASS;

· Licensing of activities e.g. for the siting and operation of workplaces handling very significant ionising radiation sources, for handling ionising radiation sources and for radioactive wastes;

· Reviewing and approving documentation related to radiation protection, ensuring security for radioactive material, emergency rules for the transport of selected radioactive sources and internal emergency plans of workplaces handling ionising radiation sources;

· Specifying conditions and requirements for radiation protection of the public and personnel handling ionising radiation sources (e.g. laying down limits and defining controlled zones), specifying emergency planning zones and licensees' emergency preparedness requirements;

· Managing the national record-keeping systems for licensees, selected import and export items, ionising radiation sources, and exposure of the public and personnel handling ionising radiation sources.

Training and information is within the responsibility of the licensees.

Financial security of orphan sources falls under the responsibility of SÚJB and the report on experience is also covered by SÚJB.

4.5.1.2. Legislative framework

The Czech Republic has fully implemented the HASS Directive into the national legal framework.

References are:

· Act. No. 18/1997 Coll. on Peaceful Utilization of Nuclear Energy and Ionising Radiation (Atomic Act)

· Regulation No. 307/2002 Coll. implemented 1.1,2005.

The activity levels in the legislation for HASS follow Annex 1 of the HASS Directive. All sources with activity levels below the high-activity levels but above the clearance levels are covered also by the above mentioned regulations, these requirements have been in force before the transposition of the HASS Directive. The main differences in the requirements regarding the HASS are records, financial security for orphan sources and report on experience.

4.5.2. Prevention and Deterrence 4.5.2.1. Authorization for practice with HASS

Before issuing an authorization for the use of HASS, all relevant issues are considered by the Regulatory Authority, including external accidents (fire, flooding …) and emergency procedures. Authorization is only granted after all relevant information is received and has been judged as being adequate by the Regulatory Authority.

An authorization for HASS has never been refused in the Czech Republic

4.5.2.2. Records keeping and updating

All HASS holders are required to maintain records of the HASS under their responsibility. An electronic or written copy of these records is to be sent to the Regulatory authority at acquisition of the source and periodically every 12 month. At important modifications, the records do not have to be sent to the Regulatory Authority. Regulations do not foresee an allowable delay for providing the records to the Regulatory Authority. The recorded information supplied by the HASS holder is in general complete.

4.5.2.3. National inventory

The information received through these records is used to maintain an electronic national inventory of authorised HASS holders and the HASS they hold, which is covering all information requested in the standard record sheet. There is a common database of radioactive sources, HASS sources are indicated. There are no HASS in the country not covered in the national data base or identified in the holder’s records. The register of authorised source holders is available to customs and police organizations on request.

4.5.2.4. Inspections and penalties

The holder’s records are available for inspection. During inspections, a systematic verification between the records in possession of the Regulatory Authority, the records by the holder and the actual situation at the licensee is performed for all HASS. Inspections (announced on a yearly basis and unannounced) are performed by the Regulatory Authority, taking care of safety, security and non-proliferation measures by a common inspection in all fields. Inspections can also take place as a follow-up in case of an incident or any other suspicious situation. The inspections are funded directly by the State. Inspectors receive training in nearly all relevant fields. The necessary equipment for performing an inspection is available and specific to the duties (safety, security and non-proliferation).

In case of non-respect of regulations, a system of administrative penalties is in place. These administrative penalties depend on the type of infraction and can range up to 50 million CZK. The system of penalties has been used in the cases of usage without authorization, breach of obligation for radiation protection in usage of HASS.

4.5.2.5. Control of HASS by the holder

Regular testing by the licensee of safety and security performances is part of the inspection. Safety tests of HASS carried out by the holder include visual verification, leak tests and dose rate measurements with individually decided frequency according to the monitoring plan and the QA programme. The competent authority is informed on the control measures implemented to prevent inadequate use etc. during the authorisation process, by regular reporting by the holder and through inspections.

4.5.2.6. Sources holders’ training

Content of the training program of HASS holder’s staff is defined by the authority and the holder. Training material is prepared by the holder. Training sessions can also be subcontracted. The frequency is once a year for radiation workers. Training sessions are recorded. A comprehensive test is organised. The performance and efficiency of training sessions is verified by checking the training records during inspection. Non-exposed workers and management staff are not trained.

Radiation protection officers are trained in radiation protection principles, specific requirements of safe management of sources, possible consequences of loss, theft or inadequate use or damage of sources, and notification to the competent authorities and emergency responses in case of accident. Exposed workers are trained in radiation protection principles, possible consequences of loss, theft or inadequate use or damage of sources, and notification to the competent authorities and emergency responses in case of accident.

4.5.2.7. Identification and marking of HASS

Usually the documentation accompanying HASS includes source identification, information and photographs of source design type, information and photographs of typical source container, information and photographs of transport packing, information and photographs of device and equipment. No HASS are reported to be present in Czech Republic without ID, but some older sources could have the same identification number.

Correct identification and marking is verified during the licensing process (QA Programme) and checked during inspection. Recommended limited working life by the manufacturer is available.

4.5.2.8. Transfers of HASS

Before the transfer of a HASS the holder ascertain that the recipient holds an appropriate authorization by asking a copy of the authorization to the recipient. There is no evidence of loss or out of control because of unrecorded transfer.

4.5.2.9. Long-term management of disused HASS

The national regulatory framework does not define a limited useful life for HASS. It is the obligation of the holder to decide whether a source is considered to be disused. When the useful life of a HASS is expired the holders have to consider either:

- source to be still suitable and therefore re-test it for a new working period;

- source to be disused and send it back to the supplier/manufacturer or to another authorised user;

- source to be disused and to store/dispose it.

The country’s policy on disused sources gives priority to returning the disused source to the supplier or transfer to another authorized user. If this would not be possible, the disused source should be considered as radioactive waste and be transferred to the national authorised waste treatment and storage facility. The actual situation of disused HASS corresponds to this policy. Storage of disused sources at the premises is however possible.

The national waste treatment and storage facility accepts disused sources; its capacity is adapted to the potential of disused sources. A situation dealing with disused sources without any financial solution for long-term management occurred. Long term management of disused HASS is usually funded by the holder, but can be financed by the State, if necessary.

Before a licence is terminated the licensee shall, with the approval of the SÚJB, provide on a contractual basis a legal successor or ensure safe termination of radiation practices. In any case the State takes care of disused sources without financial security and orphan sources, even if it is not expressed in the legal framework explicitly as an obligation.

4.5.2.10. Security measures

There are security requirements laid down in the Atomic Law and in Regulation 307/2002 Coll. on radiation protection.

4.5.3. Detection 4.5.3.1. Detection of orphan sources

A threat assessment regarding orphan sources was performed by the Regulatory Authority, yielding as strategic location for finding orphan sources: metal scrap yards, metal scrap recycling facilities, conventional waste management facilities, borders/customs and airports. Detection equipment is available on a voluntary basis for metal scrap yards, metal recycling plants, metallurgical industries, conventional waste management facilities, borders/customs, transit hubs and airports. The danger of high financial costs in the case of returned load or goods encourages the use of detection equipment on a voluntary basis.

4.5.3.2. Campaign for orphan sources recovery

The regulatory framework does not ensure that campaigns are organised and thus campaigns have not taken place. There is no dedicated budget foreseen, with little available means (lack of budget and lack of competent staff). To possibly recover disused sources, systematic inspections of facilities in insolvency are performed, based on information provided by the Ministry of Justice.

The best method to recover orphan sources is using radiation detection equipment in strategic locations. The recovered radioactive material would be transferred to the waste treatment and storage facility or returned to supplier. There is no financial strategy covering intervention costs.

4.5.3.3. International cooperation and information exchanges

There have been two cases of discovery and ten cases of illicit trafficking within the last 10 years which have been communicated to the IAEA. The competent authority has been informed about distribution of contaminated steel by a foreign country. The Czech Republic is contributing to the IAEA Incident and Trafficking Database (ITDB) since 1993.

4.5.4. Preparedness and Response 4.5.4.1. Emergency plans and procedures

The Czech Republic has no emergency response plan in operation specifically applicable in the case of orphan sources and HASS.

An emergency team is available 24/7. Available equipment is: communication devices, measurement devices, individual protection equipment, shielded containers and detection material.

There are compulsory emergency preparedness and response requirements for HASS holders and the emergency response plans and/or procedures have to be approved by the authority. There are no compulsory emergency preparedness and response requirements for the institutions where orphan sources are more likely to be found. There is a unique contact point designed in case of detection of an orphan source, which is the general emergency call number.

Contamination control of the site after source removal is outsourced to an accredited technical support organisation. They have to report to SÚJB.

4.5.4.2. Training and information of persons potentially confronted with an orphan source

Personnel potentially confronted with an orphan source are trained. Training is given in the field of emergency to first responders (police, firemen and medical staff) and in the field of transport to customs officers and airport personnel. The content of the training courses in the field of emergency includes: information concerning the potential confrontation with a source, radiation protection principles, specific requirements for safe management of sources, procedures for prompt notification to competent authorities and emergency responses in case of (potential) detection/accident and actions to be taken on site in the event of the detection or suspected detection of a source. No training is foreseen for the fields transport, facilities and for others. These training courses are voluntary and are not documented, they are not regularly repeated and there is no comprehensive test organized.

4.6. Denmark 4.6.1. Regulatory framework with respect to HASS 4.6.1.1. Regulatory authority

The competent nuclear authority is the National Institute for Radiation Protection (NIRP), which is administratively part of the National Board of Health. The NIRP is responsible for all the requirements of the HASS Directive except for the financial security matter, which is a responsibility of the State.

4.6.1.2. Legislative framework

The legislative framework in the country is based upon:

· Order no. 985 of 11 July 2007 on the Use of sealed radioactive sources, which transposes the HASS Directive and used the same definition for a high-active source as the one from the HASS Directive. This law is applicable either for HASS and non-HASS. A HASS falling below the defined high-activity levels is still covered by this law. A source is always kept under regulatory control regardless the activity level.

· Before this law, the Orders no. 308 of 24 May 1984 and no. 918 of 4 December 1995 were in force and were dealing respectively with the gamma radiographic sources and the other sealed sources. The main differences between the old regulations and new one are to be found in transfers (Article 4), records keeping (Article 5) and identification and marking (Article 7).

A source whose activity would have defined it as a HASS but whose activity had fallen down below the high-activity levels when the HASS Directive was transposed is covered by the aforementioned two orders.

4.6.2. Prevention and Deterrence 4.6.2.1. Authorization for practice with HASS

Before issuing an authorisation for the use of a HASS, the justification of use, responsibilities, staff competencies, adequacy of the source and its associated device with respect to its use, available documentation and procedures for work and maintenance, emergency procedures and communication links, control measures implemented to prevent inadequate use, unauthorized access, loss, theft, fire, flooding, etc. are considered. Arrangements for long term management of disused sources and related financial security are not considered before issuing an authorisation. (Note that this information is contradictory with the one given in 2.9.). The NIRP has refused an authorisation for use of a HASS because of an unjustified use.

4.6.2.2. Records keeping and updating

Each HASS holder has the obligation to keep records of all HASS under his responsibility and to provide the NIRP with the recorded information at the acquisition time, annually, or when the holder no longer holds or uses the source or when he stops his activities. No delay time to provide the records is prescribed in the legislation. NIRP keeps an electronic database of all authorized HASS holders and sources including all information requested in the standard record sheet given in Annex II of the HASS Directive. The non-HASS are recorded in the same database.

4.6.2.3. National inventory

According to NIRP there are no HASS in the country which are not recorded in the national database or identified in the holder’s record. The register of authorized sources holders and of HASS is available to customs organisations and to police via request to NIRP.

4.6.2.4. Inspections and penalties

During inspections, the authority (NIRP) has access to the holder’s records and check randomly the match between them and actual situation. Inspection looks at safety, security and non-proliferation fields and are organized both announced and unannounced. Inspections are funded by the State and through an annual tax linked to the authorization. Inspectors are staff from NIRP. They are equipped with all necessary equipment (individual dosimeter, contamination detectors, list and pictures of typical sources and containers, specific tools if needed).

Penalties are foreseen and have already been applied in case of breach of the national provisions pursuant to the HASS Directive.

4.6.2.5. Control of HASS by the holder

Tests carried out by the Holder to ensure the good conditions of each HASS are visual verification and dose rate measurement (no leak tests). They are performed annually and the results are communicated to the competent Authority. Their performance is also checked during inspections.

The security measures are examined during the authorization process and during inspections.

4.6.2.6. Sources holders’ training

The Holder is responsible for defining the content of the training programme of its staff and the preparation of training material. The training courses are given to the radiation protection officer and exposed workers by the Holder itself. Non-exposed workers receive a basic training on radiation protection principles. Training sessions occur every 5 years. They are recorded but no comprehension test is organized. The records of training are checked by the Authority during inspections.

4.6.2.7. Identification and marking of HASS

HASS is systematically accompanied by the necessary relevant documentation. No cases of HASS without identification or information on its nature are known to the Regulatory Authority.

4.6.2.8. Transfers of HASS

In case of a national transfer of HASS, the Regulatory authority is informed of this transfer because a license needs to be requested by the Recipient of the source. In case of an international transfer, the Competent Authority will be contacted by their counterparts of the country of the Recipient. The records of the Holder give also indication of the transfer. The Holder transferring a HASS does not check that the Recipient holds a valid authorization for the possession of the source.

No cases where HASS went out of control during transfer are known to the Regulatory Authority.

4.6.2.9. Long-term management of disused HASS

Concerning the long-term management of HASS, no limited working life is defined in the national regulatory framework. An authorization is only granted if the long-term management route is already specified and planned. Similarly the import of a new source is conditioned on its re-export.

The country’s policy on disused sources gives priority to returning the disused source to the supplier. If this would not be possible, the disused sources should be considered as radioactive waste and be transferred to an authorized waste treatment or storage facility. The re-use of the source for another application is only considered as last possibility.

The transfer of disused HASS for long-term management has to be arranged as soon as possible after termination of its use. No cases of disused source without long-term management solution are known to the Authority.

A national authorized storage facility for radioactive waste and accepting disused HASS is available in the country. Its capacity is considered as adapted to the potential amount of disused sources. Currently the long-term management of disused HASS is funded through take-back provisions incorporated in the supply contracts and through a State guarantee.

4.6.2.10. Security measures

Only locking mechanism is required for the Holder’s premises (both during use and storage). The radwaste storage facility is secured through fences, access control and locks. For mobile use, locks on the source container are used. The security measures are examined during the authorization process and during inspections.

4.6.3. Detection 4.6.3.1. Detection of orphan sources

No threat assessment regarding orphan sources has been performed by the Regulatory Authority. Detection equipment at strategic locations for finding sources is present on voluntary basis. In that context, metal scrap yards and metal recycling plants are equipped with portal and portable equipment whereas border crossings, harbours and airports are equipped with portable equipment. Nothing is planned for metallurgic industries, conventional waste management facilities and transit hubs.

4.6.3.2. Campaign for orphan sources recovery

Registries follow-up (analysis of available historical records) and specific campaigns in scrap yards and metal recycling facilities have been realized by the Authority as recovery campaigns for orphan sources. No orphan sources have so far been discovered.

No specific budget is dedicated for this topic and no financial strategy is in place for dealing with recovery and long-term management of orphan sources.

4.6.3.3. International cooperation and information exchanges

Denmark is participating in international cooperation and information exchange mainly through the established IAEA channels. The country is contributing to the IAEA Incident and Trafficking Database (ITDB). It also uses this database as an international information source.

4.6.4. Preparedness and Response 4.6.4.1. Emergency plans and procedures

Denmark does not specifically have a national emergency response plan dedicated to orphan sources or HASS. But the Danish Emergency Management Agency (DEMA) is in charge of the national nuclear emergency preparedness planning and has prepared a national nuclear emergency management plan.

The NIRP has an emergency team ready to intervene 24/7 in case of emergency with an orphan sources or HASS. The team is composed of the NIRP staff and has all necessary equipment except mobile laboratories in dedicated vehicles. Up to now, the emergency plan has never been triggered because of orphan sources detection or incident with HASS.

Also the HASS Holders are required to have emergency preparedness and response plans which have to be approved by the Authority. No such requirement applies to institutions where orphan sources are more likely to be found.

Within the emergency plans, first actions such as first instructions to public, mobilization of responders, ensuring the security of the site and source are attributed to the emergency services. The Authority is responsible for ensuring the security of the source and additionally for the radiological assessment, transport of the source and contamination control of the site after source removal.

4.6.4.2. Training and information of persons potentially confronted with an orphan source

Managers of emergency services, scrap yards, metal recycling plants, customs and waste management facilities are trained on orphan source situations. Staffs from transit hubs, harbours, airport and metallurgical industries are not trained. The training sessions address the procedures and actions to be taken in case of detection, accident or suspicion for each activity sector.

There are no requirements to have such training according to the regulations. Trainings are neither documented nor repeated, no comprehension test is organized and no practical exercises are made.

The National Board of Health has sent out guidelines, primarily aimed at the recovery industry, concerning measures relating to the discovery of radioactive substances in scrap. The guidelines include help in identifying equipment with radioactive sources and instructions on measures to take following discovery of the type of equipment concerned. The guidelines are used for training purposes by the police, firefighters, and emergency staff, etc.

4.7. Estonia 4.7.1. Regulatory framework with respect to HASS 4.7.1.1. Regulatory authority

The competent authorities in accordance with the HASS Directive are the Ministry of Environment through the Environmental Board, the Environmental Inspectorate and the Estonian Rescue Board. The responsibilities are divided among these organisations, e.g. the Environmental Board deals with authorisation, transfers, records, orphan sources and International cooperation. The Ministry of Environment deals with orphan sources, financial security for orphan sources, report on experience and transposition. The Rescue Board is the designated contact point in case of detection of an orphan source

4.7.1.2. Legislative framework

The main legal instrument is the “Radiation Act” which entered into force on 01.05.2004. The principles of radiation and nuclear safety as well as