COMMISSION STAFF WORKING DOCUMENT Control of high-activity sealed radioactive sources in Europe: Implementation of Directive 2003/122/EURATOM in EU-27 and the current EU regulatory development activities Accompanying the document Report from the Commission to the Council, the European Parliament and the European Economic and Social Committee on Experience gained in the implementation of Council Directive 2003/122/EURATOM on the control of high-activity sealed radioactive sources and orphan sources
Date: 2015-04-16
Institutions: European Commission
Subjects: EU Member State, application of EU law, environmental impact, environmental risk prevention, nuclear accident, public health, public safety, radiation protection, radioactive materials, safety standard













EUR-Lex - 52015SC0084 - EN











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52015SC0084

COMMISSION STAFF WORKING DOCUMENT Control of high-activity sealed radioactive sources in Europe: Implementation of Directive 2003/122/EURATOM in EU-27 and the current EU regulatory development activities Accompanying the document Report from the Commission to the Council, the European Parliament and the European Economic and Social Committee on Experience gained in the implementation of Council Directive 2003/122/EURATOM on the control of high-activity sealed radioactive sources and orphan sources /* SWD/2015/0084 final */









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 the
responsibilities of the licence holder are defined by this Act. Article 2 of
the Act specifies that no radiation practice should be started without a
radiation practice licence. There is no system for notification and
registration. The Environmental Impact Assessment and Auditing Act states that
the environmental impact shall be assessed upon application for if the proposed
activity results in significant environmental impact.
According to the
Article 14 of the Radiation Act, all radiation practices shall be performed
only by licence holders. Article 18 establishes requirement for license holder
to ensure finances for safe management of source after the end of its use.
Article 18 (1) lists the documents, which the applicant for a radiation
practice licence shall present, while Article 18 (3) defines the practices of
low, moderate and high risk. All practices involving radioactive waste
management and nuclear fuel cycle and the corresponding facilities, as well as
practices using high-activity radiation sources are considered as practices of
high radiation risk (Article 18 (3(1)). Article 19 establishes generic data and
conditions common for all radiation practice licences and the additional ones,
including public involvement (Article 20 and 21) in case of radioactive waste
management and nuclear fuel cycle related activities as well as work activities
within which the presence of natural radiation sources leads to a significant
increase in the exposure which cannot be disregarded from the radiation
protection point of view. 
Fulfilments of
conditions of the radiation practice licence as well as requirements of the
Radiation Act are subject to inspection and control by the Environmental
Inspectorate. The requirements for licence application are established with the
Regulation No. 41 of 29 April 2004 “The Time Limits for Proceedings to
Issue, Amend or Revoke Radiation Practice Licences, the Specific Requirements
for and Format of Applications for Radiation Practice Licences, and the Format
of Radiation Practice Licences”. In Estonia radiation practice licence is
valid up to 5 years. 
The HASS Directive
is fully transposed into the national regulatory framework; the date of
enactment was 11 June 2006. The Regulation No. 113 of 7 September 2004, which
entered into force on 19 September 2004 and was amended on 15 June 2006 deals
with “Activity Levels of Radionuclides, Requirements for the rooms
where the Radiation Sources are situated, and for Labelling rooms and Radiation
Sources”.
The regulation in
force for sources with activity level below the high-activity level defined in
the regulatory framework remains the one in force for all radioactive sources
before the transposition of the HASS Directive, namely the Radiation Act and
the Regulation of the Government No. 163 of 30 April 2004 concerning “The
Bases for Calculation of Exemption Values, and the Exemption Values for
Radionuclides” (entered into force 07.05.2004). Radiation Act,
Article 30 sets the obligations for holder of radiation practice licence. 

4.7.2.                             
Prevention and Deterrence
4.7.2.1.                       
Authorization for practice with HASS

The authorisation
for practice with HASS is done according to the Radiation Act. 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; 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.
Estonia has
refused an authorisation for the use of HASS due to a failure in the
justification of use.

4.7.2.2.                       
Records keeping and updating

The holder of a
radiation practice licence has the obligation to report an annual inventory of
the radiation sources to the Environmental Board by 1 March of the following
year (Radiation Act, Article 30). The recorded information is updated by the
authority annually and when the holder no longer uses the source. There is no
limited time delay authorised for providing the recorded information. 

4.7.2.3.                       
National inventory

With the
information electronically provided by the HASS holder, the Environmental Board
is in charge of maintaining a national inventory of authorized HASS holders and
the HASS they hold. Entries shall be made either for the import or use of a
radiation source based on the information contained in the radiation practice
licence (Radiation Act, Article 37). The information recorded is the one
requested in the standard record sheet given in Annex II of the HASS Directive.
The sources not covered by the HASS Directive are recorded in the same
database. The registry of licence holders is available to police organizations
and only partially to customs organizations.

4.7.2.4.                       
Inspections and penalties 

Acting as an
expert body, the Environmental Board is in charge of inspections of HASS
holders in the field of Safety (Sf), Security (Sc) and Non-proliferation (Np)
whilst the Environmental Inspectorate inspects on a routine basis both the Sf
and Sc domains. A periodic inspection of authorised holders is announced and
organised once per year for Sf and Sc. Random inspections are also organized
and unannounced for Sc. 
The inspectors are
trained on 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 equipment of the inspectors
consists of individual dosimeters; contamination detectors; pictures of typical
sources and containers. The inspection is funded directly by the State.
Holders’
records are available for inspection. During inspections and at least every 12
months for all the HASS, the Authority checks the match between the actual
situation of the HASS and the information recorded by the Holder.
The penalties for
breaches are as follows: 
·        
Use
of radiation source without radiation practice license: up to 300 fine units.
The same act, if committed by a legal person, is punishable by a fine of up to
3200 euros.
·        
Violation
of the requirements determined by a radiation practice license: up to 300 fine
units. The same act, if committed by a legal person, is punishable by a fine of
up to 3200 euros.
·        
Conveyance
of radiation sources containing radioactive substances and conveyance of
radioactive waste across the state border without an appropriate permit up to
300 fine units. The same act, if committed by a legal person, is punishable by
a fine of up to 3200 Euros.
·        
Delivery
of radiation sources containing radioactive substances and delivery of
radioactive waste to a person who does not hold a radiation practice licence:
up to 300 fine units. The same act, if committed by a legal person, is
punishable by a fine of up to 3200 euros

4.7.2.5.                       
Control of HASS by the holder

The control on the
HASS and its associated device by the Holder is performed during inspections
and by receiving the tests results, generally carried out once a year by visual
verification and dose rate measurement.

4.7.2.6.                       
Source Holders’ training

According to the
Regulation of the Minister of Environment N° 86 of 8 July 2004 – Requirements
for Exposed Workers Radiation Safety Training – the HASS Holder defines
the training program of its staff, prepares the training material and gives
every 5 years the training sessions which concern the Radiation Protection
Officer and the exposed workers. The programme includes the radiation
protection principles, the safe management of sources, consequences of loss,
theft and inadequate use of sources, emergency responses in case of accident,
etc. The training sessions are recorded but no comprehension test is organized.
The performance and efficiency of the training sessions is carried out by
checking training records during authorisations and inspections. 

4.7.2.7.                       
Identification and marking of HASS

The documentation
accompanying a HASS systematically includes the source identification,
information and photographs of source, container, transport packaging device
and equipment.  To the knowledge of the authority, there are no HASS in the
territory without identification number. There is no HASS manufacturer in
Estonia as well as no recommended limited working life for the use of HASS.

4.7.2.8.                       
Transfers of HASS

Before
transferring a HASS, the Holder ascertains that the Recipient holds the
appropriate authorisation by asking a copy of it, by direct contact with the
Authority of the Holder’s and Recipient’s country. The Authority
issues an authorisation/permit for the transport and issues an authorisation to
the Recipient in case of a National transfer.  
No lost or out of
control of sources has been encountered because of unrecorded transfer

4.7.2.9.                       
Long-term management of disused HASS 

The national regulatory
system does not define a limited useful life for HASS. The preferred and
encouraged strategy for the long-term management of the disused sources is the
return to the supplier. The solutions actually implemented are the return to
the supplier, the transfer to authorized radioactive waste storage facility and
in some case the storage at the holder’s premises for a maximum period of
5 years (Radiation Act). The transfer for reuse to another authorised holder
has never been implemented given the very limited HASS users in the country.
There is a
national authorized storage facility for radioactive waste that accepts disused
HASS on condition that radioactive waste package acceptance criteria should be
followed by the Holder.
The authorisation
for practice with HASS is issued only if the long-term management of the HASS
after termination of its use is defined. The long-term management of disused
HASS is funded by take-back provisions incorporated in the supply contract and
in funds set by the Holder. One situation with a disused source without
long-term management solution has been encountered. The source (Cs-137) was
produced in the 70ties and stored in the Holder premises. The solution
implemented was the transfer to the authorised waste storage facility.

4.7.2.10.                   
Security measures

The minimum
compulsory security requirements for the holder’s premises - HP- (both
during use and storage) and for the authorised radioactive storage facility
–ARSF- concern fences and sources with locks (HP), Video surveillance,
access control, locked premises, fire detection (HP+ARSF). 

4.7.3.                             
Detection
4.7.3.1.                       
Detection of orphan sources

During the threat
assessment carried out by the authority at national level, the strategic
locations identified to detect orphan sources were metal scrap yards, borders/customs,
harbours and airports. Metal recycling plants, metallurgical industries and
conventional waste management facilities were not included.
The detection
equipment available is of portable type and portals. The controls are voluntary
at metal scrap yards and harbours with exception at the border/customs and
airports where the controls are mandatory. 

4.7.3.2.                       
Campaign for orphan sources recovery

The regulatory
framework does not ensure that campaigns to recover orphan sources are
organised and no specific budget is assigned to that. Nevertheless recovery
campaigns have been organised in 2009 and 2010 by the Ministry of Environment
and the company A.L.A.R.A. Ltd. During those campaigns 214 sources were
recovered and transferred to the A.L.A.R.A. storage facility.
The most effective
type of recovery campaign was by means of public announcement.
The intervention
costs related to recovery and long-term management of orphan sources were
supported by the State.

4.7.3.3.                       
International cooperation and information
exchanges

In the last 10
years Estonia has informed 19 times of the discovery of orphan sources to the
IAEA Incident and Trafficking Database and reported 3 times on cases of illicit
trafficking. Estonia contributes to this database since 1997. 

4.7.4.                             
Preparedness and Response
4.7.4.1.                       
Emergency plans and procedures

Estonia has a
national radiological emergency response plan in place with relation to HASS
and orphan sources. An emergency team is available to intervene 24/7 in case of
emergency with an orphan source or HASS, namely the Rescue Board as first
responder with a team of minimum 3 persons and the Environmental Board as
second responder with 1 person. The Rescue Board is designated as unique
contact point with a general emergency call number in case of detection of
orphan sources. Its coordinates are broadcasted to potentially involved people
through information campaigns to institutions likely to be confronted with
orphan sources, emergency services (police, firemen, civil protection, etc.)
and to general public.
Dedicated vehicle,
Communication and measurement devices, individual protection equipment,
shielded containers and decontamination materiel is the equipment available for
the emergency team. Emergency services are in charge of ensuring the security
of the site and of the source and transport of it.
There are also
compulsory emergency preparedness and response requirements for the HASS
holders which need to be approved by the Authority. No emergency response plans
and procedures are however required for the facility operators where orphan
sources could be found.  

4.7.4.2.                       
Training and information of persons potentially
confronted with an orphan source

The personnel
potentially confronted with an orphan source are trained. The training is
addressed to both workers and managers of first responders, customs officers,
personnel of scrap yards and waste management facilities. Only the emergency
services get regular national training.

4.8.                                   
Finland 
4.8.1.                             
Regulatory framework with respect to HASS
4.8.1.1.                       
Regulatory authority

Regulatory control
of the use of radiation, including radioactive sources, is stipulated by the
Radiation Act. According to this Act, the competent nuclear authority is the
Radiation and Nuclear Safety Authority (STUK) which shall supervise the
compliance with the Act and with the provisions and regulations issued pursuant
thereto. Furthermore, the Radiation Act designates the police and customs
authorities as responsible to furnish official assistance as necessary in
supervising compliance with the provisions of the Radiation Act and with the
regulations issued pursuant thereto. The role of customs authorities in import
and export of radioactive substances is specified in the Radiation Decree.
STUK is
responsible for all the requirements of the HASS Directive except for the
transposition matter which is a responsibility of the State. Penalties are
issued by the police or the court. STUK can set a conditional fine.

4.8.1.2.                       
Legislative framework

The national
legislative framework fully transposes the HASS Directive through amendments of
Radiation Act (22.12.2005, n° 1178/2005, Chapter 8 A) and the Radiation
Decree (29.12.2005, n° 1264/2005, Chapter 5 A).
These documents
use the same definition for a high-active source as the HASS Directive. The law
is applicable both to HASS and non-HASS. A HASS falling below the defined
high-activity levels is still covered by this law. A source is excluded from
regulatory control when its activity level is below the exemption levels
specified in the Directive 96/29/EURATOM. The law was already in force for all radioactive
sources before the transposition of the HASS Directive. The main differences
between the old version and amended one are to be found in authorization
(Article 3), records keeping (Article 5), requirements for holders (Article 6)
and report on experience (Article 14). 
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 law.
According to a
definition in the Directive, a source is classified as a high-activity source
according to its activity at the time of manufacture. Therefore, a source that
has ‘once been a high-activity source will always remain such’
irrespective of whether its activity has decreased to a very low level as a
result of physical decay. This means that sources having the same level of
activity are subject to different requirements depending on their history
rather than on the actual risk from the source. The holders of a safety
authorisation regard this as unfair. The regulatory authority shares this view:
it does not seem justified to subject certain sources having the same risk
level to stricter control than others solely because of their different
history. The current situation does not correspond to the generally applicable
principle that the control should be risk-based (i.e. a graded approach). They
also pointed out the problem of the activity levels set out in the Directive
which are not consistent with the classification of sources in the standards of
the International Atomic Energy Agency (IAEA).

4.8.2.                             
Prevention and Deterrence
4.8.2.1.                       
Authorization for practice with HASS

Before issuing an
authorisation for the use of a HASS, all relevant items are considered by the
Regulatory Authority. The STUK has not yet refused an authorisation for use of
a HASS.

4.8.2.2.                       
Records keeping and updating

Each HASS holder
has the obligation to keep records of all HASS under his responsibility and to
provide STUK annually with the recorded information before the end of January
of the following year. Next to these records, licensees have to notify all
modification to the radiation sources and devices within a time frame of 2
weeks after the implementation of the modification.
Up to now, STUK
receives complete information and in due time, except for the periodical
(annual) transfer where some delay is encountered. STUK 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. Thus information of all sources
is in one database.

4.8.2.3.                       
National inventory

According to STUK
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
source holders and of HASS is available to customs organisations and to police
on request.

4.8.2.4.                       
Inspections and penalties 

During
inspections, the authority (STUK) has access to the holder’s records and
checks the match between them and the actual situation for each HASS.
Inspection looks at both safety and security. In Finland there are no HASS that
belong to the non-proliferation regime. Generally, inspections are announced to
the licensee and come at intervals of 3-5 years. Very few unannounced
inspections have been made. Follow-up inspections in case of incidents or
accidents are made only when this is judged necessary. Inspection scope covers
all relevant items except contamination measurements. Inspections are paid by
the licensees.
Inspectors are
staff from STUK. All inspectors (safety, security and non-proliferation ones)
are trained for each relevant field. Their equipment consists of individual
dosimeter, contamination detectors, list and pictures of typical sources and
containers and specific tools if needed.
Penalties (fine or
imprisonment) are foreseen in case of violation of the Radiation Act or of the
Criminal Act. They have never been applied up to now. 

4.8.2.5.                       
Control of HASS by the holder

Tests carried out
by the Holder to ensure the good conditions of each HASS are visual
verification and leak tests (no dose rate measurement). It is required to
perform them at least once per year and the report of those shall be
communicated to the competent Authority annually. Their performance is also
checked during inspections. In the majority of the cases, these leak tests
consists of swipe tests on the external surface of the source holder.
The security
measures are examined during the authorization process and during inspections. 

4.8.2.6.                       
Sources holders’ training

The content of
Radiation Safety Officers’ training is defined by the Authority. For
other staff, the training is defined by the Holders. An organisation recognized
by the Authority or the Holder itself may be involved in preparing the training
material. Training courses are given to the radiation protection officer and
exposed workers. Non-exposed workers receive a basic training on radiation
protection principles. The management does not receive any training.
Training sessions
occur at a rate of 5h every 5 years for workers and 10h every 5 years for
radiation safety officers. They are recorded and a comprehension test is
organized for Radiation Safety Officers. The training records are checked by
the Authority during inspections. Verification is also included in the review
and assessment of a new license application.

4.8.2.7.                       
Identification and marking of HASS

HASS are
systematically accompanied by the necessary relevant documentation as per the
Radiation Decree. No cases of HASS without identification or information on its
nature in the country are known to the Regulatory Authority.

4.8.2.8.                       
Transfers of HASS

The Holder
transferring a HASS has to check that the Recipient holds a valid authorization
for the possession of the source by asking a copy of it to the Recipient and
has to notify STUK within 2 weeks of the transfer, just like the receiver in
case of a national transfer. In case of an international transfer (outside EU)
of HASS, the prior approval of STUK shall be sought. STUK shall ensure from the
regulatory authority of the destination that there is no impediment to the
transfer of a HASS in the said country and that the recipient of the transfer
is authorised to receive the source.
Furthermore, the
Regulatory authority is informed of the transfer because a license needs to be
requested by the Recipient of the source. The licenses detail the individual
sealed sources (with activity above exemption levels) and in case of renewal or
exchange of a sealed source, an amendment to the license is required. 
No cases where
HASS went out of control during transfer are known to the Regulatory Authority.

4.8.2.9.                       
Long-term management of disused 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. 
The
country’s policy on disused sources gives priority to returning the
disused source to the supplier. The next preferred option is the transfer of
the source for re-use in another application. If this would not be possible,
the source should be considered as radioactive waste and be transferred to an
authorized waste treatment or storage facility. The actual situation of disused
HASS does not exactly reflect this policy because disused sources are transferred
to storage facility rather than re-use in another application. Some disused
sources are stored at the Holder’s premises. This is the case for some
older unused HASS sources which, for various reasons, cannot be returned to the
manufacturer or stored in the national long-term storages. 
Although storage
at the user’s premises of sources that have no foreseeable use is not
allowed, the regulations do not define a specific time limit before which the
transfer of disused HASS is mandatory. Compliance with this requirement is a
particular point of attention to STUK, but it is not strictly enforced. This
approach has drastically reduced the number of sources in this case and STUK is
estimating that currently less than 10 disused sources are stored at users’
premises.
Cases of disused
sources without long-term management solution (or financial solution for it)
are known to the Authority. These are historical sources whose manufacturer no
longer exists. So far, these sources are stored at Holder’s premises. A
potential solution would be to extend the capacity of the radwaste storage
facility. Other solutions are sending these sources to other recycling plants.
A national
authorized storage facility for radioactive waste is available in the country.
Currently it does not accept disused HASS but arrangements in that sense are
ongoing (extension of the existing facility). Sending back of the HASS to the
manufacturer and transfer for re-use to another authorised facility are the
other foreseen options to help the management of the disused HASS.
Currently the
long-term management of disused HASS is funded through take-back provisions
incorporated in the supply contracts. For very high activity sealed sources
(activity exceeding 100 times the activity limits for HASS), a fund needs to be
set up by the Holder. As per the Radiation Act, this fund could be a bank
guarantee (under the control of STUK), credit insurance or a security of
comparable reliability prescribed by the Decree of the Council of State.

4.8.2.10.                   
Security measures

At installations
where HASS are present, access control, locked premises, locking mechanism for
the source and fire detection are planned for the Holder’s premises (both
during use and storage). The radwaste storage facility is secured through the same
devices except the lock on the source. Moreover video surveillance is required
in premises if sources activity exceeds IAEA category 1.
Mobile HASS
sources are mainly used in gammagraphy and in some cases also temporary stored
at work sites. Locks are present on the source container and if storage at work
site occurs then these sites are secured by access control and fire detection.

4.8.3.                             
Detection
4.8.3.1.                       
Detection of orphan sources

No comprehensive
risk/threat assessment regarding orphan sources has been performed by the Regulatory
authority but locations where orphan sources can be identified have been
considered. These strategic locations are metal scrap yards, metal scrap
recycling facilities, metallurgic industries, borders/customs, harbours and
airports.
Detection equipment
at strategic location for finding sources is present on a voluntary base. Such
initiative is encouraged through information dissemination by leaflets, in
seminars and at other training occasions. The equipment used does not have to
be authorized by the competent authority. In that context, the major
installations of this type are equipped with portal and portable equipment
except metal scrap yards only equipped with portable one. 

4.8.3.2.                       
Campaign for orphan sources recovery

No recovery
campaign has been organized in the country because no orphan sources from past
or present activities are expected to be found. Consequently no specific budget
is dedicated for this topic. The monitoring of scrap metal is considered as the
best method to recover the greatest number of orphan sources. The recovered
orphan sources are either returned to the supplier either transferred to the
radwaste facility. There is a financial strategy in place for dealing with
recovery and long-term management of orphan sources. These costs are supported
by the State and the sources’ Holders.

4.8.3.3.                       
International cooperation and information
exchanges

Finland 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) since 1995. It uses this database as
an international information source.

4.8.4.                             
Preparedness and Response
4.8.4.1.                       
Emergency plans and procedures

Finland has a
national radiological emergency response plan dedicated to orphan sources or
HASS. STUK’s preparedness organisation is available on short notice. The
team has all necessary equipment. The team can be reached through the general
emergency call number or directly by phoning to STUK.
Also the HASS
Holders are required to have procedures for abnormal events. These are checked
during inspections and during review and assessment of new license
applications. No such requirement applies to institutions where orphan sources
are more likely to be found.
Within the
emergency plans, the first instructions to public are made by the emergency
services. In collaboration with the Authority, they are also responsible for
the mobilization of responders, ensuring the security of the source and its
transport. In collaboration with the Authority and the Radiation Protection
Expert they perform the radiological assessment of the site. The licensee and
the police have the responsibility to secure the site. Finally the
contamination control of the site after source removal is performed by the
licensee together with the Authority and the Radiation Protection Expert.

4.8.4.2.                       
Training and information of persons potentially
confronted with an orphan source

Training of
persons potentially confronted with an orphan source is not prescribed in the
regulations. Workers and managers of emergency services and of customs are
trained on all the relevant items. Workers of metallurgic industries receive
training only on potential confrontation with a source and procedures and
actions in case of detection or accident. Staffs from other fields are not
trained. 
Record keeping of
training courses is not mandatory but most organisations (e.g. emergency
services, customs, etc.) have training databases where information is stored.
They are not regularly repeated and no comprehension test is organized. The
training sessions do include practical exercises dealing with portal detectors,
hand-held instruments, list and pictures of typical sources and containers and
specific area for safely locate and identify the source. 

4.9.                                   
France 
4.9.1.                             
Regulatory framework with respect to HASS
4.9.1.1.                       
Regulatory authority

While applying and
insisting on the principle of the prime responsibility of the operators, the
French regulatory framework foresees different actors involved in the control
of radioactive sources and their transfer. These actors are the authorities and
the Institute for Radiological Protection and Nuclear Safety (IRSN). The
authorities are:
·        
ASN
(Authority for Nuclear Safety), the independent administrative authority in
charge of licensing and inspecting the holders, users and suppliers of
radioactive sources (excluding defence activities).  
·        
ASND
(Nuclear Security Authority for Defence), in charge of all activities with
radioactive sources and linked to defence of the French Territory.
However, in view
of administrative procedure simplification, when the establishment is subject
to an authorization from the States representative in the Department
(prefecture) for activities different from the possession and use of
radioactive sources, the detention and the use of such source is integrated in
this authorisation and regulated by Prefect. In that specific case, the
inspections are also conducted by the services of the prefecture. The aim of
this simplified procedure was to have a single authorisation issued by one
authority. However, this simplification is going to change in the near future
thanks to a decree that will change the regime applicable to these
installations. After the enactment of this decree, all sealed radioactive
sources will be under the authority of the ASN (and ASND) so that the ASN (and
ASND) will be in charge of all HASS holders in the future.
The Institute for
Radiological protection and Nuclear Safety (IRSN) is the technical support
organisation of the ASN. The Institute also manages the national inventory of
ionising radiation sources and the control of their movements/transfers for all
users.
The authorities
are responsible for the updating of the list of authorizations issued and
declarations received for activities they are regulating. This list together
with copies of authorizations and attestations of declarations issued are then
transferred by the authorities to the IRSN. This list is also made available to
labour and radiation protection inspectors by the IRSN.
The ASN with the
technical support of IRSN is designated as the competent authority in
accordance with the Council Directive 2003/122/Euratom on the control of
high-activity sealed radioactive sources and orphan sources (HASS Directive).
The ASN is responsible for the requirements of the HASS Directive dealing with
the articles 3 (authorization), 5 (records), 8 (training and information), 9
(orphan sources), 10 (financial security for orphan sources), 11 (international
cooperation), 12 (inspections), 14 (report on experience), 15 (penalties), and
16 (transposition) while the IRSN is responsible for the article 4 (transfers)
but is also involved in the articles 5 (records), 8 (training and information)
and 11 (international cooperation). 

4.9.1.2.                       
Legislative framework

The current French
regulatory framework related to the protection of the population against
ionizing radiations is resulting from the transposition of the EU Directives
Euratom (in particular 90/641, 96/29, 97/43 and 2003/122) and is integrated
into two coherent codes: the French labour code and the French public health
code and different ministerial decrees and orders.
The requirements
of the HASS directive are transposed into the French public health code and the
French labour code but also in the French environment code and different
ministerial decrees.
The same
definition and related activity levels as those specified in the HASS directive
are being used for defining HASS in the French legal framework. The provisions
regulating the management system apply to all sealed radioactive sources with
activity above the exemption levels. Nevertheless, some additional provisions
are specifically required for HASS. The main differences in requirements for
the management of HASS and non HASS are to be found in the system of transfer
recording, training of users and the identification and marking. In particular,
the requirements of HASS directive concerning articles 5 (transfers) and 7
(identification and marking) will be transposed in an ASN Resolution shortly
(official consultation in progress). 
A source defined
as a HASS remains regulated by the requirements for HASS when its activity
level falls below the high-activity levels. Similarly, a source whose activity
had fallen down below the high-activity levels when the HASS directive was
transposed is regulated by the HASS regulation. A source is not subject to
authorization (exempted from the regulatory control) when its activity level is
below the exemption levels specified in the Directive 96/29/Euratom as long as this
activity level has never been higher than this exemption level. In other words,
decay is not taken into account to change the applicable regime.

4.9.2.                             
Prevention and Deterrence
4.9.2.1.                       
Authorization for practice with HASS

Before issuing an
authorization for the use (or supply) of HASS, the ASN ensures that all
arrangement and provisions of article 3 of the HASS Directive are met, namely
justification of use, responsibilities, competencies, procedure for work and
maintenance, emergency procedures, long term management and financial security,
control measures to prevent external accidents (fire, flooding …). The
security measures implemented to prevent inadequate use, unauthorised access,
loss or theft are not major issues in the licensing process until now. Since
the ASN is currently not yet officially in charge of the security issues,
safety concerns are considered more in details than security. The security
aspects are only partially covered in that frame by the potential impact theft
and fire could have on the radiation protection. However, ASN should be
entrusted as the regulatory authority for security issues for most of French
HASS and the assessment of these issues will then be integral part of the
licensing process.
Authorization is
only granted after all relevant information is received and has been judged as
being adequate by the regulatory authority. The ASN has already refused
authorization for the use of HASS because the applicant was not able to confirm
the level of safety.

4.9.2.2.                       
Records keeping and updating

All HASS and
non-HASS holders are required to keep up to date records of the activity and
location of radioactive substances under their responsibility. The records are
kept at the workplace and have to be readily available for inspection. 
The inventory of
ionizing radiation sources requested by the regulation is made of two
components: the national file of radioactive sources and the list of declared
and authorised activities. The national file allows individually monitoring of
each sealed radioactive source whose activity is higher than the exemption
levels when the source is held by a holder or user. Moreover, the national file
of sources allows knowing the responsible body for each radioactive source. The
update of this file is made by:
·        
The
pre-registration of the transfers;
·        
The
cross-check between the pre-registration of movements, the periodical reports
for holders (yearly) and suppliers (quarterly), and the list of authorized
activities;
·        
The
recovery certificates issued by suppliers when sources are taken back.
The authorisation
for a transfer of a sealed radioactive source (including HASS) must be obtained
before the actual movement of the source (prior authorisation). The suppliers
have to provide their inventory of the distributed sources each 3 months. The
holders have to provide their inventory directly to the IRSN in a written or
electronic form every year with a tolerated delay of 3 months. 
In the future the
holders of HASS will be requested confirm the reception of a HASS to the
consignor within 48 hours (for cat. 1 & 2) or a month (cat. 3) while the
source certificate must be sent to the IRSN within the month for all sources.
The IRSN
crosschecks the stock declared by the holders every year with the inventory
recorded on the basis of pre-registration of the transfers and the quarterly
supplier’s declarations. In case of discrepancy, questions are asked to
the holder in order to correct the data of the national inventory. (But the
inventory recorded in the national register is never sent to the user.)
All sources
covered and non-covered by the HASS directive and their holders (or suppliers)
are then recorded at the national level in the same electronic database used to
establish a national inventory of radioactive sources. The following data are
recorded: holder’s details, isotope, activity at a reference date, type
of source, type of equipment/container, manufacturer details, location of
sources, mobile or fixed source. The updating of the national inventory is
ensured and controlled by the recording and the comparison of the periodical
information provided by holders, users and suppliers.
The access to this
inventory is eased by the use of the SIGIS system (system of information and
management of the inventory of ionising radiation sources). All these data and
the national inventory are managed by the IRSN and the records are available to
ASN and radiation protection inspectors  but also to police and customs
organizations for some specific cases. 
To the knowledge
of the authority, there are no HASS presently used in France which are not
recorded in the national inventory. 

4.9.2.3.                       
National inventory

From the
authorised holders, the vast majority is from the industry sector. Several
hundred HASS are used in mobile devices (gammagraphy) and have a special form
certificate. Several thousand HASS for fixed use have also a special form
certificate (medical sector and industry, research and education). During
inspections, a systematic verification between the records of the national
inventory and the actual situation at the licensee is performed.

4.9.2.4.                       
Inspections and penalties 

In France, three
levels of inspection exist:
·        
Internal
controls performed by the Radiation Protection Officer 
·        
External
control performed by the IRSN or recognised organisations
·        
Inspections
by the ASN on the basis of regulation requirements.
Inspectors of the
ASN are in charge of radiation protection and safety inspections for HASS
holders. The inspections are directly funded by the State.
In the safety
field, the inspections are carried out either periodically (every year to every
3 years), or randomly or as follow-up actions in case of incident. The scope of
inspections related to safety concerns the documentation, a visual inspection
of HASS, dose rate measurements of leakage radiation, contamination checks and
a check of the inventory at the holder. For each inspection, an extract of the
national inventory is compared to the holder’s one. Otherwise, technical
visits are currently performed by ASN inspectors in order to anticipate the
future requirements when they will be officially in charge of the security
aspects. The answers are given by the holders on a voluntary basis.
The practical
training of the inspectors concerns information regarding radiation protection,
their potential confrontation with a source, the visual detection of sources
and containers and the specific requirements for their safe management.
Inspectors dealing with security aspects receive training about the possible
consequences of loss, theft or inadequate use of sources and procedures/responses
to be followed in case of an emergency situation. Their standard equipment is
composed of individual dosimeters and radiation detectors. Inspectors do not
receive practical training in nuclear metrology.
In case of
breaches of the national provisions a system of penalties is in place with a
maximum penalty of 15 000 € and 1 year imprisonment. Penalties have
already been applied for lack of authorization or serious risks.

4.9.2.5.                       
Control of HASS by the holder

The ASN also
checks during inspections the regular performance of suitable tests by the
holder to control the good conditions of each HASS and associated device
(integrity, place of use or storage). The checks generally performed by the
holder are visual inspections, test of good operation of the device, dose rate
measurements and test of non-contamination (smear test) as close as possible to
the HASS. These tests, as specified in an ASN Resolution, take place every 3
months.

4.9.2.6.                       
Sources holders’ training

Training and
information must be provided to the workers likely to be exposed to ionizing
radiation. The content of the training programme for the source holder’s
staff is defined and given by the holder. The holder is responsible for the
training for all the workers while only the Radiation Protection Officer (RPO)
is trained by the IRSN or by one of the organizations recognized by the ASN.
The training sessions are recorded. A comprehension test is organized at the
end of the training session of the RPO. It is worthwhile to note that more
training is required for some specific activities such as industrial
radiography and a certificate (CAMARI) is issued after written and oral
examinations.
The training
sessions are given at least every 3 years for the staff and every 5 years for
the RPO. A reinforced training is required by the regulation for the workers
likely to be exposed to HASS. The content of the training programme concerns
radiation protection principles, specific requirements for safe management of
sources, consequences of loss, theft or damage of sources and emergency
response in case of accident. The authority verifies the performance and
efficiency of the training sessions by checking the training records during
inspections.

4.9.2.7.                       
Identification and marking of HASS

Currently, there
is no HASS manufacturer in France. The HASS used in France come from the USA,
Canada, Russia and EU Member States. Limited working life recommended for HASS
by the manufacturers supplying France is not considered in the French
regulation. The documentation accompanying a HASS systematically includes the
source identification on the source or on the container. To the knowledge of
the authority, there are no HASS in the territory without identification
number.
Information and
photographs of the source design type, typical source container, transport
packaging, device and equipment are not included in the document accompanying
the HASS. Indeed, the correct identification and marking of the HASS is not
currently verified because the transposition of the article 7 of the HASS Directive
is currently being revised.

4.9.2.8.                       
Transfers of HASS

Any transfer of
radioactive sources is managed by a registration system with prior declaration
and authorisation. Before each transfer, a special form has to be filled in and
sent to the IRSN (Public health code articles R. 1333-47 to 49). For all sealed
sources, the form is recorded by the IRSN when the cross-checking between the
authorization, the sources already held by the holder and information from the
form are coherent. 
The IRSN, manager
of the national inventory, is in charge of the control of any transfers of
radioactive sources. The comparison of the periodical information and records
provided by holders, users, and suppliers with the request for transfer allows
the IRSN to be informed of any individual transfer of HASS. This control is
performed by the IRSN that informs the ASN which can take the necessary actions
in case of unauthorised transfer or undeclared transfer.
In case of
national transfer and as already mentioned, the transfer is recorded in the
national inventory prior to the physical transfer. To ensure that the transfer
is still authorized at the moment the source is physically delivered, the
holder needs to be confirmed at the moment of the transfer that the recipient
holds the appropriate authorization by asking a copy of the authorization. In
their records, both the new recipient and the former holder have to mention the
new situation and location of the HASS. The holder must be able to justify the
origin and the destination for each source held on site.
From his side, the
supplier has to send every 3 months a report to the IRSN giving information on
all the sources delivered and received during the period. In case of EU
transfer, according to the articles 4 and 6 of the Directive EURATOM 1493/43,
the transfer must be declared to the IRSN and an inventory from the European
suppliers is supposed to be sent to IRSN every 3 months. 
In case of
international transfer, the holder must ascertain that the recipient holds the
appropriate authorisation. If the laws in the recipient’s country are not
similar with the French ones, he can also contact the national competent
authority of the recipient’s country to ensure it. 
No cases where
HASS went out of control during transfer are known to the regulatory authority.

4.9.2.9.                       
Long-term management of disused HASS

The French Public
health code defines a limited useful life of 10 years for all sealed sources,
including HASS. Once this period is expired or once the source is no more used
before the period of 10 years, the source must be either sent back to the
supplier/manufacturer or re-tested for a new working period of 5 years,
renewable once. In this case, the holder must submit an authorization request,
including an advice from his supplier. 
The aim of this
policy is to avoid the storage of disused sources at the user’s premises.
In this regulatory regime the user is required to ensure the taking back of the
source; the supplier has the obligation to recover any source he has
distributed, ensure the taking-back of the source delivered and must provide a
financial guarantee in this regard.
The ASN requests
at the time of source delivery the commitment of the foreign manufacturer to
take back the source. The commitment of the manufacturer towards the French
supplier is contractual while the taking-back of the source by the French
supplier is a regulatory obligation.
Currently an
authorization for using HASS is issued only if the long term management route
is specified and planned in the request for authorization. By order of
preference, the strategies nationally encouraged for the long term management
of the disused sources are (i) return to the supplier, (ii) transfer to a
producer for recycling (iii) transfer for reuse to another authorized holder
(in France for less than 10 years old sources, abroad for others) and (iv)
transfer to authorized radioactive waste treatment/storage facility. The
capacity of the authorized national storage facility of ANDRA would not be
adapted if the sources are not returned to the suppliers. However, in some case
and depending on the origin of the sources, the authorized national storage
facility of ANDRA may accept disused HASS. Some concerns were encountered with
the long-term management of old sources for which the suppliers do not exist
anymore. In that case, the sources were returned to other suppliers or stored
on site, or recovered by ANDRA.
Long-term
management of HASS is funded by the suppliers, and sometimes included in the
cost of their contracts with holders. Since 1990 this funding is secured by a
guarantee fund. A financial warranty is paid by the supplier for each source
delivered. Suppliers can either pay a guarantee to ANDRA or contribute to a
common fund with an annual fee to cover the working costs of the association.
This fund is used for the management of sources that have to be taken back if
the supplier does not exist anymore. For all the sources concerned since the
implementation of the financial guarantee in 1990, the costs of recovering
these sources would be covered by this system. For older sources uncovered by a
financial guarantee, a fund dedicated to the recovery of orphan sources in case
of failure of the supplier/manufacturer exists and its management is ensured by
ANDRA.

4.9.2.10.                   
Security measures

The regulatory
requirements regarding the security of HASS are under parliament approval. A
graded approach is considered. 

4.9.3.                             
Detection
4.9.3.1.                       
Detection of orphan sources

A threat
assessment concerning the orphan sources has been performed at national level
by the authority, giving as strategic location for finding orphan sources,
conventional waste management facilities, harbours and transit hubs. Most of
these sites are currently equipped with portal detection means. The
installation of detection equipment is compulsory for metal scrap yards, metal
scrap recycling facility and conventional waste management facilities.
Nevertheless, the type of equipment is not imposed by the authority and the
equipment must not be authorised. Moreover portable equipment is used on voluntary
basis in harbours and transit hubs. 

4.9.3.2.                       
Campaign for orphan sources recovery

Campaigns for
orphan sources recovery have been organized in France although it is not
required by the regulatory framework. The campaigns are selectively organised
based on the type of sources but not on a regular frequency. A specific budget
is dedicated to the recovery campaigns and the means available are considered
as sufficient. The radionuclides mainly collected were radium and tritium under
the form of needles, watches, radium fountains, etc. These were organized by
ANDRA on a voluntary basis. The recovered sources were returned to
suppliers/manufacturers when identified or transferred to authorized storage
facility.
Review of
historical records of sources available at the authorities, the suppliers, the
manufacturers and the licensees and systematic inspections of facilities are
performed to recover orphan sources. National recovery campaigns have been
organized by ANDRA to recover tritium and radium sources, objects containing
uranium, lightning rods, ionizing smoke detectors, etc. These campaigns aim at
informing the public on how to identify these items and the procedure to
declare and dispose them off.

4.9.3.3.                       
International cooperation and information
exchanges

Over the last 10
years, the ASN has not been informed directly on HASS recovery or malicious
acts but obtains some information mainly through the channel of the ECURIE
database. The Direction of International Relation of the CEA (CEA/DRI) is the
official contact for ITDB in France.

4.9.4.                             
Preparedness and Response
4.9.4.1.                       
Emergency plans and procedures

France has no
national radiological emergency plan in relation with orphan sources or HASS
since the emergency response plan is organized at department level. Each
department shall have its own emergency response plan which could be different
from one to another department. In case of an accident/incident with HASS in a
facility licensed by the ASN, the decision and the implementation of protection
measures with respect to the safety of persons within the site belongs to the
head of facility (hospital, laboratory, industry) in conformity with an
internal emergency plan under article L.1333-6 of the Public health code. The
prefect is concerned with the safety of persons on the public domain. 
In case of an
accident occurring in a place where there is no responsible person identified
(orphan source discovery), the responsible body of the radiation protection
intervention is the prefect of the department depending on the magnitude of the
accident.  
Up to now, no
emergency plan has already been initiated for HASS. There are contact points
designated in case of detection of an orphan source.

4.9.4.2.                       
Training and information of persons potentially
confronted with an orphan source

The French labour
code obliges the employer to train his workers in facilities where orphan
sources are likely to be found. The training and its content is organized and
defined under the responsibilities of the employers. It is addressed to workers
and managers of the emergency services (police, fire fighters, and medical
staff), and to workers of scrap yards, metal recycling plants and waste
management facilities. For people who could be confronted to orphan sources,
the training required in the labour code must contain information and advice
about how to visually detect a source or its packaging, about radiation and
their effects, and about the measures to be undertaken on site in case of
detection or suspicion of detection of such a source. 

4.10.                               
Germany 
4.10.1.                         
Regulatory framework with respect to HASS
4.10.1.1.                   
Regulatory authority

Germany
has a federal system with 16 independent Federal States. Each federal state is
responsible for the licensing procedure of HASS. In every federal state exists
one or more competent authorities (approx. 60 competent authorities in Germany)
for licensing and control of HASS. The register for HASS is operated by the
Federal Office for Radiation Protection, BfS. All competent authorities have
read-access to the register. The Federal Ministry for the Environment, Nature
Conservation and Nuclear Safety is responsible for the transposition of the
HASS-Directive into national law, international cooperation and report on
experience.

4.10.1.2.                   
Legislative framework

Germany
has fully implemented the HASS Directive into its national legal framework with
the following instruments:
·       
Gesetz zur Kontrolle
hochradioaktiver Strahlenquellen. Enacting Modification of the Atomgesetz, issued 15
July 1985 (BGBl I, page 1565), last amendment from 24 February 2012 (BGBl I,
page 212);
·       
Strahlenschutzverordnung
(Radiation Protection Ordinance), issued 13 October 1976 (BGBl I, page 2905),
last amendment from 18 August 1997 (BGBl I, page 2113);
·       
Atomrechtliche
Deckungsvorsorge-Verordnung, issued 25 January 1977 (BGBl I, page 220), last
amendment from 23 November 2007 (BGBl I, page 2631) and Atomrechtliche
Abfallverbringungsverordnung issued 30. April 2009 (BGBl I, page 1000).
The
activity levels in the German legislation 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 Radiation Protection Ordinance, these
requirements have been in force before the transposition of the HASS Directive.
A HASS decayed below the defined high activity levels is covered by the provisions
for non-HASS. Existing sources which would have been declared as HASS before
the transposition of the HASS Directive are also covered by the provisions for
HASS. A source can leave regulatory control when its activity is below
clearance levels. 

4.10.2.                         
Prevention and Deterrence
4.10.2.1.                   
Authorisation for practice with HASS

Before
granting an authorisation 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. Authorisation by local competent authorities is only granted
after all relevant information is received and has been judged as being
adequate.

4.10.2.2.                   
Records keeping and updating

All
HASS holders are required to maintain records of the HASS under their
responsibility. Furthermore, every HASS holder is obliged to send electronic
notifications about receipt, transfer, location change, control, loss, theft or
finding of a HASS to a central database, the national HASS registry, which is
operated by the BfS. The notifications are done electronically via secure
internet connections. The data, which have to be submitted in a notification,
correspond to the required information of the standard record sheet of the HASS
Directive, which has been adopted in detail by the German Radiation Protection
Ordinance. The local competent authorities verify if all notifications are in
compliance with the licence granted. All notifications to the HASS registry
have to be done immediately except notifications about regular inspections,
which have to be done within one month. No information to the authority is
requested when the holder no longer uses the source or no longer uses any
source, but the HASS holder is generally obliged to return the HASS to the
supplier or manufacturer, when the use of the HASS is no longer intended. 

4.10.2.3.                   
National inventory

The
recorded information in the database of the HASS registry establishes a
national inventory of all HASS used in Germany, their history and respective
holders to allow federal as well as local authorities and task force/police
organisations to trace back HASS within Germany. The registration of sources
below the HASS levels falls within the competences of the local authorities.

4.10.2.4.                   
Inspections and penalties

The
holder’s records are available for inspection by the competent
authorities. During these 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. Verification is realized for each HASS.
All competent authorities are responsible for inspections of HASS holders. The
main focus of these inspections lays on the safety, but covers security aspects
as well. 
Inspections
are usually announced to the licensee, but unannounced inspections are possible
if appropriate in specific cases. Inspectors receive training in all relevant
fields, including practical experience in metrology and the necessary equipment
(individual dosimeters and contamination detectors but no dose rate survey
meters) is available. The scope of an inspection covers all relevant fields of
safety. In case of non-respect of regulations, penalties are foreseen. The
system of penalties has not been applied up to now.

4.10.2.5.                   
Control of HASS by the holder

The
competent authority verifies regular performance of suitable tests by the
holder during the inspections; this includes usually visual verification and
leak tests. These tests are done by external accredited radiation protection
experts. 
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 authorisation process, and verifies it during
inspections. All controls of HASS have to be notified to the HASS registry.

4.10.2.6.                   
Sources holders’ training

The
content of the training programme of HASS holders’ staff is defined by
the authority.  The holder and the radiation protection officer (RPO) are
responsible for an adequate training. The training programme is prepared by the
holder and organisations recognised by the authority. For occupationally
exposed personnel the period is 12 months. Management staff and non-exposed
workers are not trained. Training sessions are recorded, but there is no
comprehension test. The performance and efficiency of the training sessions is
verified through regular reporting by the holder, as required by the competent
authority.
Both
radiation protection officers and exposed workers 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. 

4.10.2.7.                   
Identification and marking of HASS

Usually
the documentation accompanying the HASS includes source identification,
information and photographs of source design type, information and photographs
of typical source container & information and photographs of transport packaging.
In a few cases, where HASS without an ID had to be registered, the BfS issued a
registration number for the HASS registry. There are HASS with non-unique
ID’s or ID’s which re-appear in a certain time interval for
nuclides with a short half-life depending on the manufacturer. Therefore, it
would be desirable to establish a system of unique HASS-ID’s among the
manufacturers and suppliers.

4.10.2.8.                   
Transfers of HASS

In
Germany, the Bundesamt für Wirtschaft und Ausfuhrkontrolle (BAFA) is
responsible for import and export of radioactive sources.
The BfS maintains the central register for HASS, while all other sources are
registered by the federal states. Inspections provided by the authorities of
the federal states are carried out once a year and registered, as is the case
for any transfer of sources.
Before
the transfer of a HASS, the holder has to ascertain that the recipient holds an
appropriate authorisation. This is a legal obligation, but various procedures
are in place. The competent authority is informed of individual transfer of
HASS from the holder’s records, by issuing an authorisation/permit to the
holder for the transfer, by issuing an authorisation/ permit for the transport
and by issuing an authorisation to the recipient in case of a national transfer.
There is no evidence of loss or out of control because of an unrecorded
transfer.

4.10.2.9.                   
Long-term management of disused HASS 

The
working life of a HASS is not defined by the national regulatory framework. The
country’s policy on disused sources gives priority to returning the
disused source to the supplier or manufacturer. Another possibility is the
transfer to another authorised 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 national waste treatment
and storage facility accepts disused sources. If the capacity of the facility
is not adapted to the potential of disused source the source has to be sent
back to the manufacturer. The current management situation of disused HASS
corresponds to this policy. Storage of disused sources at the holder’s
premises is possible. The holder can be authorised to store the HASS after
termination of the use on his premises; this depends on the requirements in the
license. The holder is forced to make arrangements for a safe and secure
long-term management after termination of use because authorisation is issued
only if the long-term management route is already specified and planned. Up to now
no situations dealing with disused sources without any long-term management
solution have occurred.
The
long-term management of disused HASS is funded by “take back”
provisions incorporated into the supply contract and/or by a fund set by the
holder.  There has been no situation without any financial solution for
long-term storage of a disused HASS.

4.10.2.10.               
Security measures

According
to the German radiation protection ordinance, the licensee is obliged to fulfil
the requirements for the use of HASS, which also cover security requirements.
Detailed security measures are laid down in the German Industry Standards
(DIN). Every competent authority can decree special conditions for security
measures within a single licence by a case to case decision. A guideline for competent
authorities dealing with general security requirements is currently being
drafted.

4.10.3.                         
Detection
4.10.3.1.                   
Detection of orphan sources

A
threat assessment regarding orphan sources has been performed by the Regulatory
Authority. Metal scrap yards, metal scrap recycling facilities, metallurgic
industry, conventional waste management facilities, borders/customs, harbours,
transit hubs and airports were identified as strategic locations to detect
orphan sources. Portal and portable detection equipment is available at these
strategic locations on a voluntary basis, except for borders/customs, where
they are compulsory. The equipment does not need to be authorised by the
Regulatory Authority, nor is its type imposed by the Regulatory Authority. To
encourage the use of detection equipment on a voluntary basis a commitment by
the industry has been agreed upon.

4.10.3.2.                   
Campaigns for orphan sources recovery

The
regulatory framework does not foresee that campaigns are organized, but the
competent authority can initiate campaigns if necessary. There is no special
budget dedicated for this.
After
the reunification of Germany, campaigns to recover orphan sources were
conducted. Currently no further campaigns exist or are planned. It is assumed
that most orphan sources have been found and taken care of. Nevertheless, it is
to be noted that strategic transportation routes, recycling centres and metal
facilities are checked regularly and the facilities carry out voluntary
measurements.
The
following actions have been realized: systematic analysis of the historical
records at the authority, investigation in the former holder’s records,
systematic inspection of facilities, aerial surveys and specific campaigns in
former military sites. The radionuclides mainly collected are Co-60 and Cs-137.
The scope of the recovery campaigns was based on the use of mobile sources and
geographical area. The recovered radioactive material has been returned to the
supplier/manufacturer or has been transferred to the waste treatment and
storage facility. There is no financial strategy covering intervention costs
but in any case the federal states take care of safe and secure disposal.

4.10.3.3.                   
International cooperation and information
exchanges

There
have been more than ten cases of theft, more than ten cases of loss and more
than ten cases of discovery of sources within the last 10 years. The
information has been communicated to the IAEA Incident and Trafficking Database
(ITDB). Germany has been contributing to the IAEA Incident and Trafficking
Database (ITDB) since its establishment.

4.10.4.                         
Preparedness and Response
4.10.4.1.                   
Emergency plans and procedures

Germany
has a general emergency response plan in operation, also applicable in the case
of orphan sources and HASS. In every federal state the competent authorities
have appropriate measures in case of discovery of orphan sources. Additionally,
the Federal Office for Radiation Protection has the capability to provide
support in case of important radiological incidents. Available equipment is:
dedicated vehicles (mobile laboratory), communication devices, measurement
devices, individual protection equipment, shielded containers and detection
material. The emergency plan has not been initiated because of orphan sources
or an incident with HASS.
There
are compulsory emergency preparedness and response requirements for HASS
holders. For institutions where orphan sources are more likely found, these are
in general not required. This depends on the decision of the competent
authorities on case by case basis. The contact points in case of detection of
an orphan source are the local competent authorities.

4.10.4.2.                   
Training and information of persons potentially
confronted with an orphan source

A
quite extensive and adequate training and information plan is offered on a
voluntary basis for all people who could potentially be confronted to orphan
sources, but only at the level of the workers. There is no training foreseen
for the management and also no training for other people. Training sessions are
not documented and are repeated periodically on a voluntary basis. There are
companies which offer these courses. A comprehension test is encouraged but not
mandatory. However, the people that require this type of training in order to
carry out their official work duties in case of emergencies do get a
comprehension test.

4.11.                               
Greece 
4.11.1.                         
Regulatory framework with respect to HASS
4.11.1.1.                   
Regulatory authority

The competent
Authority in accordance with the HASS Directive is the Greek Atomic Energy
Commission (GAEC). It deals with all articles of the HASS Directive.

4.11.1.2.                   
Legislative framework

The Greek
framework for safety is set out primarily in a number of laws, decrees and
common ministerial decisions. In particular:
·        
Legislative
Decree 181/1974 “Protection against Ionising Radiation” 
·        
Law
No. 1733/1987 “Transfer of Technology, inventions, technological
innovation and establishment of the Greek Atomic Energy Commission”
·        
Ministerial
Decision No. 17176 “Powers and competences of GAEC Administration
Board”
·        
Presidential
Decree No. 404/1993 “Organisation of the Greek Atomic Energy
Commission” 
These legislative
measures provide for the initial establishment of an authorisation procedure
for the use of ionising radiation in Greece, the issuance of regulatory
decisions, compliance, monitoring and penalties. In addition, they provide for
the establishment of the Greek Atomic Energy Commission (GAEC) as an autonomous
legal entity within the public sector and for the powers and competencies of
the GAEC Board. More detailed regulations are set out in a suite of legislative
measures based primarily on the transposition of EURATOM directives concerning
radiation protection and nuclear safety.
The HASS Directive
is fully transposed in the national regulatory framework and the date of
enactment was the 31st May 2006 through the publication in the Government Gazette
of the Ministerial Decision No. 10828/(EFA)1897 “Control of high-activity
sealed radioactive sources and orphan sources”.
The definition of
a HASS in the national regulatory framework is the same as the one of the HASS
Directive. The same activity levels are used. GAEC applies in practice the HASS
MD (and consequently the HASS Directive) to all radioactive sources – in
a graded approach – irrespective of their form and activity.
In practice, all
sources are kept under regulatory control regardless the activity. However,
GAEC may exclude a source from regulatory control if the source
holder/user/operator declares and proves that the source activity is below
exemption levels.

4.11.2.                         
Prevention and Deterrence
4.11.2.1.                   
Authorization for practice with HASS

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; 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.
Prior to import of
every radiation source - irrespective of the activity, type and isotope -, a
legal written declaration from the source manufacturer, stating that the
manufacturer will take back the source after its useful life is necessary.
Also, a legal written declaration from the source user stating that he/she will
undertake all financial and administrative provisions to export the source back
to manufacturer or other licensed storage/recycling facility abroad. 
GAEC has never
refused an authorization for the use of a HASS. 

4.11.2.2.                   
Records keeping and updating

HASS records are
kept by the holder and are subjected to GAEC inspections periodically (during
operation licence renewals or earlier). According to HASS MD, the holder must
provide to GAEC the records at least once a year. In case of minor or major
changes to the facility, the holder submits the relevant records to GAEC
without delay. GAEC performs announced and unannounced inspections
periodically, at least once a year – regardless the license validity
period – and assesses HASS records. 
The information is
sent by the HASS holder to the GAEC in written form. The records kept by the
holder include sufficient information. However the detailed points of Annex II
are difficult to be followed and sometimes there is missing information. 

4.11.2.3.                   
National inventory

GAEC maintains the
national registry of radiation sources irrespective of their activity, type and
isotope. GAEC maintains a National Radiation Protection Database which is
regularly updated by the GAEC staff. The electronic database includes:
facilities, licensing details, inventory of radiation sources, inspection
results, dose registry, and education level of the occupationally exposed
workers, radioisotopes distribution/supply and transport. The database provides
for an automatic notification prior to the expiry of licenses/or certificates
of compliance. GAEC will inform the licensee accordingly to avoid the delays in
the renewal of the license. 
The register of
authorised sources Holders is available for inspection to police organisations
and to customs under request. During inspections, the Authority checks the
match between the actual situation of the HASS and the information recorded by
the Holder.

4.11.2.4.                   
Inspections and penalties 

The GAEC is in
charge of the inspection of HASS holders for Safety (Sf), Security (Sc) and
Non-proliferation (NP). The planning is organised once per year on Sf and Sc
(announced) and randomly (unannounced) for both. The inspections cover NP only
as follow-up action in case of an incident or any other suspicious situation
and also once before the first licensing of the facility. 
The inspectors are
trained on Sf and Sc issues on the following fields: 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 training on NP
regards the possible consequences of loss, theft or inadequate use or damage of
sources and the procedures for prompt notification to the Authority and
emergency responses in case of accident. The inspectors' equipment consists of
individual dosimeters; contamination detectors; portable survey meters, spectrometers.
For the Sc, no instruments are used; for Sc tests on security measures and
visual inspections are performed; for NP no tests are performed.
The inspections
are paid by the licensees and funded directly by the State. GAEC charges the
licensees, however if needed, GAEC covers the expenses by its own budget. 
There are
penalties applicable to breaches. In addition to any penal sanctions,
infringement of the provisions of this Joint Ministerial Decision shall entail
administrative sanctions. The foreseen penalties have not yet been applied in
practice. In a few cases the operation license has been suspended.

4.11.2.5.                   
Control of HASS by the holder

The competent
Authority verifies the regular performance of suitable tests on the HASS and
its associated device during inspections. The tests, generally carried out
yearly, are visual verification and dose rate measurement. The competent
Authority is informed on the control measures implemented during the
authorization process, by regular reporting by the holder and during
inspections. 

4.11.2.6.                   
Sources holders’ training

The definition of
the training program of the HASS holder staff is done by both the GAEC and the
Holder. The training material is prepared by the Holder and approved by GAEC.
The training sessions are not recorded and no comprehension test is organized.
Training is given at the start of the job but no frequency is defined to repeat
it. The Authority verifies the performance and efficiency of the training
sessions through regular reporting by the Holder: in fact, during inspections,
staff (ad hoc) is interviewed by GAEC, while the RPO of the facility provides
relevant information (in oral in most cases). The categories subjected to
training are the radiation protection officer and the exposed workers. 

4.11.2.7.                   
Identification and marking of HASS

All HASS are
accompanied by their certificate from manufacturer and all documentation
necessary (drawings-design in place of photographs in most cases). The correct
identification of the HASS is checked by the Regulatory authority only by the
source certificate. Operators perform measurements of the dose rates (radiation
output) for the purpose of their job. Recently, the suppliers of HASS have
recommended a limited working life, which is generally 10 years.

4.11.2.8.                   
Transfers of HASS

For transfers of
HASS between facilities from different countries, documents which have been
approved by the competent authorities of the recipient country must be granted
prior the shipment. These, validate that the recipient is capable for the safe
and secure management of the HASS. Additionally the import or export license
must be issued by GAEC in advance; its issue is possible only if the holder (in
case of export) or the recipient (in case of import) has been authorized. For
transfers between facilities within Greece, the recipient has to obtain the
authorization in advance. 
Additionally, in
both cases mentioned above, the transport license has to be issued either to
the holder (for export) or the recipient (for import) prior the transfer.

4.11.2.9.                   
Long-term management of disused HASS 

The national
regulatory system does not define a limited useful life for HASS. The disused
source must be sent back to supplier/manufacturer. There is also the
possibility to ask from the manufacturer to renew - update (if possible) the
working life. The preferred strategy is the transfer for reuse to another
authorised holder, then the return to supplier then transfer to storage
facility. 
There is a
national authorized storage facility for radioactive waste that accepts disused
HASS, for short-term storage and then exporting for recycling to an authorised
facility abroad. Long-term management of disused HASS is funded by take-back
provisions incorporated in the supply contract and by funds set by the Holder.
Another alternative is that prior to import of HASS, the holder declares to
undertake all costs for the back-end solution.
Up to now, the
long-term management of disused HASS are not hindered due to financial reasons.
However, the finance for the export of disused HASS for recycling may become a
significant problem.

4.11.2.10.               
Security measures

Security measures
required at Holder’s premises during use and storage of the HASS are:
video surveillance, recorded control access, locked premises, security staff,
lock on the source, fire detection and others means such as motion detection
systems, sirens and visual alarm panels. Nothing is required at places of
mobile use and in storage facilities.

4.11.3.                         
Detection
4.11.3.1.                   
Detection of orphan sources

A threat
assessment has not been performed on a rigid and "real life" basis.
The strategic locations identified to detect orphan sources are metal scrap
yards, metal recycling facilities, metallurgical industries, conventional waste
management facilities, borders/customs, harbours and airports. Portal and
portable are available in all these locations and are compulsory for metal
scrap yards, metal recycling facilities, metallurgical industries and
borders/customs. Only major metal scrap yards operate portals. The
availability of detection equipment is voluntary for conventional waste
management facilities, harbours and airports. 
The detection
equipment applied does not need to be authorised by GAEC. GAEC performs
inspections, provides advices on the use and is always informed in case of
alarms (true, innocent or false). The use of detection equipment on a voluntary
basis is encouraged through the national policy on illicit trafficking of
radioactive material. Telemetric monitoring is also available.

4.11.3.2.                   
Campaign for orphan sources recovery

The regulatory
framework ensures that campaigns are organised to recover orphan sources from
past activities, through the production and distribution of leaflets and
through informing relevant organizations, bodies and professions. GAEC has an
appropriate dedicated budget of 100 000 € to recover and manage orphan
sources. One recovery campaign has been organised. The recovered sources are
transferred to the storage or to a recycling facility.

4.11.3.3.                   
International cooperation and information
exchanges

Greece contributes
to the IAEA Incident and Trafficking Database since 2000.

4.11.4.                         
Preparedness and Response
4.11.4.1.                   
Emergency plans and procedures

Greece has a
national radiological emergency response plan in place with relation to HASS
and orphan sources. There is an emergency team available to intervene 24/7 in
case of emergency. The team of about 30 is composed of GAEC scientific and
technical personnel. The equipment available is composed of dedicated vehicles,
communication and measurement devices, individual protection equipment,
shielded containers and decontamination material.
There is
compulsory emergency preparedness and response requirements for HASS holders
and the procedures have to be approved by the Authority. There are also
compulsory emergency preparedness and response requirements for the facility
operator of institutions where orphan sources are more likely to be found.
These procedures should also be approved by the Authority. 
There is a unique
contact point designated in case of detection of an orphan source (GAEC –
Licensing and Inspection Division).

4.11.4.2.                   
Training and information of persons potentially
confronted with an orphan source

The personnel
potentially confronted with an orphan source are not specifically trained.
Specific training is addressed only to workers of the different categories
(emergency, transport, facilities). Training courses are obligatory according
to the regulations, but they are not regularly repeated and not all are
documented. Comprehension tests are not always organised. 

4.12.                               
Hungary 
4.12.1.                         
Regulatory framework with respect to HASS
4.12.1.1.                   
Regulatory authority

The nuclear
regulatory authority having the prime responsibility in the field of safety and
security of ionizing radiation sources is the Hungarian Atomic Energy Authority
(HAEA). However, Radiation Health Centres of Government Offices share the
responsibility for most of the requirements of the HASS Directive:
authorisation, transfers, records, training and information, orphan sources,
inspections, report on experience, penalties and also transposition. 
The HAEA is the
sole authority dealing with the financial security of orphan sources as well as
with international cooperation. In addition to HAEA and Radiation Health
Centres, the Office of the Chief Medical Officer has also responsibility in the
authorisation process. This Office is also involved in the report on experience
and penalties.
The Police has
several responsibilities linked to the implementation of the HASS directive
such as inspections, report on experience and penalties. 

4.12.1.2.                   
Legislative framework

The legislative
framework in the country is based upon:
·        
Act
on Atomic Energy (Act CXVI) which was approved by the Hungarian Parliament in
December 1996 and entered into force on July 1st, 1997
·        
Act
on Public Health (Act CLIV) promulgated on December 1997.
Both Acts and the
governmental and ministerial decrees based on them already covered several
provisions of the HASS Directive when it entered into force on 31/12/2003.
Other provisions of the HASS Directive were afterwards implemented by amending
the existing decrees. 
The HASS Directive
is fully transposed in the national framework through the following documents:
·        
Act
CXVI of 1996 on atomic energy
·        
Act
CLIV of 1997 on public health
·        
Decree
of the Minister of Health 16/2000 (VI.8.) on the execution of certain
provisions of Act CXVI of 1996 on Atomic Energy associated with radiation
protection 
·        
Decree
of the Minister of Transportation, Communication and Energy 11/2010 (III.4.) on
the order of registration and inspection of radioactive materials and related
data supply
·        
Government
Decree 112/2011 (VII. 4) on the scope of activities of the Hungarian Atomic
Energy Authority in connection with its international obligations including the
European Union, its authority and penalizing rights, the assignments of its
co-authorities and on the Scientific Committee assisting the HAEA`s activity
·        
Governmental
Decree 17/1996 (I.31.) on the actions in connection with the found or
confiscated radioactive or nuclear materials 
·        
Governmental
Decree 72/2000 (V.19.) on the special conditions of acquiring the possession
rights of certain materials, equipment and facilities belonging in the scope of
application of atomic energy, as well as on the procedure for reporting their
possession and operation 
·        
Decree
of the Minister of the Interior 47/2012 (X. 4.) on the tasks of the police in
connection with the application of atomic energy.
This framework
regulates the use of all types of radiation sources, including HASS.
Requirements for authorization regime, holders, identification and marking,
training, orphan sources, financial security, penalties are similar for HASS
and non-HASS. However, requirements related to transfers, records and
inspections are different for HASS. 
A source is
excluded from the aforementioned regulatory framework when its activity level
is below the exemption levels specified in the Directive 96/29 Euratom.

4.12.2.                         
Prevention and Deterrence
4.12.2.1.                   
Authorization for practice with HASS

Before issuing an
authorisation for the use of HASS, all relevant issues are considered by the
regulatory authorities (both HAEA and Radiation Health Centres): justification
of use, assignment of responsibilities, user’s competencies, adequacy of
the HASS with respect to its use, available documentation, measures to prevent
external accidents (fire, flooding …), physical protection, financial
security and emergency procedures. However, the adequate arrangement for the
long term management of the disused HASS is not a prerequisite for the
authorisation granting. The source remains under the holder responsibility
until the final disposal.
An authorization
for using a HASS has been refused because the authorization request was not in
compliance with the requirements.

4.12.2.2.                   
Records keeping and updating

All sealed
radioactive sources are recorded in a central registry, operated by the HAEA.
The central registry system has been in operation since the end of the 1960s
and it provides for the regulatory control of radioactive sources throughout
their full life-time. The HASS holders are required to keep records of HASS
under their responsibility. The recorded information is supplied
electronically. The unified computerised central registry system is based on
regular electronic reports of inventory changes and annual inventories, and a
passport identifying each sealed source that contains all relevant technical
data as well as details of the owner of the source. 
The information
recorded by the holders is considered as complete by the HAEA and cover all the
information requested by the standard record sheet given in annex II of the
HASS Directive. Non-HASS are recorded in the same database 
In addition to the
records kept by the holders, the owners of sealed radioactive sources must
obtain official certificates by HAEA which confirm the ownership of the sealed
radioactive source and identify individually the sealed radioactive source. 

4.12.2.3.                   
National inventory

The national
inventory of HASS holders and the HASS they hold established by HAEA is based
on the information recorded and provided by the holder. The register of HASS is
available to the Police but also to customs on request.
HAEA regularly
controls local records of holders. During inspections, a systematic
verification between the records in possession of the HAEA and the actual
situation at the licensee is performed for all HASS. The verification is made
randomly at the holder’s premises but at least for all HASS every 48
months. 

4.12.2.4.                   
Inspections and penalties 

The inspections
are directly funded by the State. They are based on risk informed approach;
frequency is adapted with the category of the source and laid down in the
inspection plan. Inspections are either announced or unannounced or conducted
as a follow-up action in case of suspicious situation. 
The inspection
scope encompasses safety, security and non-proliferation issues. The 10
HAEA’s inspectors are in charge of inspections in the fields of security
and non-proliferation while the 7 Radiation Health Centres inspectors are
responsible for safety issues. 
In addition to the
HAEA's inspection activities, the special authorities (Radiation Health Centres
of Government Office, the Police) taking part in the licensing procedure may
also carry out separate official inspections.
Inspectors receive
training in all relevant fields: practical experience in metrology  information
related to potential confrontation with a source, visual detection of sources,
safe management of sources, procedures in case of emergency and possible
consequences of loss, theft, inadequate use or damage to sources. All
inspectors have individual dosimeter, dose rate survey meter and contamination
detector. 
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 range from
170 € to 10 500 € for the company and to 5 years of imprisonment
for the person. The system of penalties has never been applied so far.

4.12.2.5.                   
Control of HASS by the holder

Regular testing of
the good conditions of each HASS and associated device by the HASS holder are
required according to the legislation. Safety tests of HASS include dose rate
measurements and leak tests. Only those holders who have appropriate technical
background are able to carry out leak tests not only for themselves but for
other holders as well. The HAEA verifies the regular performance of these tests
during inspections. The control measures implemented by the holder to prevent
inadequate use, unauthorised access, loss or theft of the HASS and the damage
by fire and flooding are also part of the inspection. 

4.12.2.6.                   
Sources holders’ training

HASS
holder’s staff requires training, which is defined by the authority (the
Office of the Chief Medical Officer) and training organisations recognised by
the authority for this purpose. The training sessions are recorded but no
comprehension test is performed. The sessions are organised annually for
security awareness and every five years for safety aspects. Training concerns
safety, security, transport and radiation protection. Radiation protection
officer and exposed workers receive training on radiation protection
principles, specific requirements for the safe management for sources, possible
consequences of loss, theft or inadequate use or damage of sources, prompt
notification and emergency response. The management staff receives the same
training session except about the specific requirements for the safe management
of sources. Non-exposed workers only receive information about radiation
protection principles. 

4.12.2.7.                   
Identification and marking of HASS

HASS need to be
systematically accompanied by the necessary documentation. This documentation
contains the source identification number together with information and
photographs of source design type. Some old sources produced in Russia are in
the territory without a readable identification number. 
The manufacturers
supplying HASS in Hungary recommend a limited working life which depends on
production technologies of the HASS and the field of application. When not set
by the manufacturer, national authorities define a recommended working life of
15 years as a first step.

4.12.2.8.                   
Transfers of HASS

In case of transfer
of HASS, the HASS holder must ask a copy of the recipient authorisation before
the transfer is made. In the cases of international transfers, Euratom rules
are followed for transfer within EU countries while the Code of Conduct
requirements apply for transfer in non-EU countries.  The HAEA is informed of
the transfer from the records of the holder via electronic reports, which are
required to be sent to the Central Registry of the HAEA No cases where HASS
went out of control during transfer are known to the Regulatory Authority.

4.12.2.9.                   
Long-term management of disused HASS 

No enforcement
exists to force the HASS holder to make adequate arrangement for the long term
management of disused HASS. The country’s policy on disused sources gives
priority to returning the disused source to the supplier although take-back
provisions must not be legally included in the supply contract.
Once the
recommended working life expires, storage in safe and secure manner at the user
premise is the alternative if not take-back provisions are included in the
contract. The holder is authorised to store the HASS after termination of its
use on his premises until the expiry of the license for storage. Radiation
Health Centres of Government Office give specific licenses for temporary storage
upon request of the holder. In that case, the disused HASS should be considered
as radioactive waste and be transferred to the Radioactive Waste Treatment and
Disposal Facility at Püspökszilágy prior to the expiry date of the
corresponding storage license. The facility has sufficient space and
infrastructure to handle the spent sources safely. The fees charged for
disposal are sufficiently low in order to ensure that the lack of financial
resources on the side of users should not be an obstacle to safe disposal.
Today, the
long-term management of HASS is funded through take-back provisions
incorporated in the supply contracts and by the Central State Financial Fund.
The source of this fund is provided from the payments of nuclear power plant.
No cases of disused HASS without long-term management have been encountered.

4.12.2.10.               
Security measures

The minimum
compulsory security requirements depend on the ratio of the isotope specific
activities. HASS manufacturers, the Radioactive Waste Treatment and Disposal
Facility, and all holders of radioactive sources (not only HASS) - both in fix
and mobile use - are required to implement a physical protection (security)
system corresponding to the security level of their radioactive sources. Such
system should include fences, video surveillance, recorded control access,
locked premises, security staff, and sources with lock according to the
legislation. 

4.12.3.                         
Detection
4.12.3.1.                   
Detection of orphan sources

A threat
assessment regarding orphan sources has been performed by the HAEA, yielding as
strategic location for finding orphan sources metal scrap yards, metal scrap
recycling facilities, metallurgical industries, border crossings, and airports.
However, conventional waste management facilities are excluded. At all of these
locations, detection equipment is mandatory. They are required to be all
equipped with portal monitors as well as portable radiation detectors at border
crossings and airports. Although the use of detection equipment is compulsory
by the law, HAEA does not impose the type of equipment to be installed.
However, the detection equipment must be authorised by the HAEA. Schengen
borders are equipped with portal detectors and special shielded parking places
to park suspicious transports.

4.12.3.2.                   
Campaign for orphan sources recovery

So far, no
specific recovery campaigns of orphan sources have been organised in the
country. 

4.12.3.3.                   
International cooperation and information
exchanges

Hungary 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) since 1994.

4.12.4.                         
Preparedness and Response
4.12.4.1.                   
Emergency plans and procedures

Hungary has a
national radiological emergency response plan in operation. However, HASS or
orphan sources are not specifically addressed in the plan which covers all kind
of radiological incidents/accidents. HASS holders on the other hand are
required to establish an on-site emergency response plan, which needs to be
approved by the HAEA. The same requirement applies for facility operators where
orphan sources are more likely to be found. The establishment of such on-site
emergency response plan is part of the authorisation documentation. 
In case of
emergencies involving HASS or orphan sources, the Regulatory authority has an
emergency team available to intervene 24/7. This team has full radiological
intervention equipment available (mobile laboratories, measurements devices,
protection equipment. etc.). No dedicated phone number exists for HASS or
orphan sources and the emergency team is reached through the general emergency
phone number. 
Within the
national emergency plan all required actions are attributed to responsible
organisations. 
Based on the
Hungarian experience, the best follow-up actions after the detection of an
orphan source are fast alerting, secure of the zone, radiation protection check
followed by a safe and secure transport and storage of the source. 

4.12.4.2.                   
Training and information of persons potentially
confronted with an orphan source

A quite extensive
and adequate training and information plan is mandatory by regulation for all
people who could potentially be confronted to orphan sources (emergency
services, custom officers and facilities such as scrap yards, metallurgical industries,
etc.) but mainly at the level of the workers. The content of the training
covers information concerning potential confrontation with a source, visual
detection of sources and containers, radiation protection principles, possible
consequences, procedures for prompt notification and actions to be taken.
These training
sessions are documented and repeated every 2-5 years depending on the level.
There is a comprehension test organised. The emergency trainings include also
table top exercises, practical exercises on identification of real sources of
ionising radiation.

4.13.                               
Ireland 
4.13.1.                         
Regulatory framework with respect to HASS
4.13.1.1.                   
Regulatory authority

The Radiological
Protection Institute of Ireland (RPII) is the competent national authority with
responsibility for ensuring that Irish people and the environment are
adequately protected from the harmful effects of ionising radiation. The RPII
being the only one named competent authority in Ireland with regard to the HASS
Directive; it deals with all the requirements of the articles of the HASS
Directive.

4.13.1.2.                   
Legislative framework

The legislative
framework in the country is based on the Radiological Protection Act, 1991
as amended. Statutory Instruments (SI) principally take the form of
Regulations or Orders and they are referred to as being secondary legislation.
The SI N° 875 of 2005 also called “Control of High Activity Sealed
Radioactive Source Order” enacted 31st December 2005 fully transposes the
HASS Directive requirements in the Irish regulatory regime. Report on the
experience gained from the implementation of the HASS Directive was sent to the
EC on January 2011. The same definition and related radiological criteria are
being used for defining HASS as those used in the Directive. Under the Irish
legislation a HASS is always a HASS until it decays below the exemption values
listed in Directive 96/29/EURATOM.
The Regulation in
force for sources with activity levels below those defined by HASS is the SI N°
125 of 2000 (Ionising Radiation Order, 2000). Although many of the
provisions required by the HASS Directive were already implemented in Irish
legislation by S.I. No. 125 of 2000 and the Radiological Protection Act 1991,
the main differences in the requirements for HASS and non-HASS are to be found
in identification and marking (art.7), training and information (art.8), orphan
sources and financial security for orphan sources (art. 9 &10) and report
on experience (art. 14).

4.13.2.                         
Prevention and Deterrence
4.13.2.1.                   
Authorization for practice with HASS

Under Irish
regulatory system a licence is required for all practices involving radioactive
sources, materials or irradiating apparatus and must be obtained in advance of
conducting any of the practices. Licences for HASS are a part of the normal
licensing system. Under Article 5(1) of S.I. No. 875 of 2005 a licence must be
obtained from the RPII in advance for any practice involving HASS and all such
licenses are issued under, and in accordance with Article 4 of S.I. No. 125 of
2000. Licences are issued for fixed periods ranging from 1-4 years and all
licence amendments must be authorised in advance by the RPII.
Before issuing an
authorisation, 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; 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 long-term management of the HASS must be specified prior to
authorisation. The conditions of licences for HASS have annual requirements in
relation to the upkeep of take-back agreements and the provision of adequate
financial arrangements for ultimate disposal in the event of bankruptcy.
An authorisation
for the use of a HASS was never refused in Ireland.

4.13.2.2.                   
Records keeping and updating

HASS holders are
required to keep records of all HASS under their responsibility. The HASS
holder provides the RPII with the recorded information as soon as possible
after acquisition and following transfer/return to the manufacturer. The
information is provided either electronically or as paper copy. 

4.13.2.3.                   
National inventory

The recorded
information is used to establish a national inventory of authorised HASS
holders and the HASS they hold. The national database contains information
about all licensees and all sources, not just HASS licensees and HASS sources.
The information recorded for HASS in the database is in compliance with the
data given in the standard record sheet of the Annex II of the HASS directive.
Access to the
database of radioactive sources is not available to the police but information
is made available to them. The records kept by the holders are routinely
inspected during regulatory inspections and the licensee inventory should match
the HASS sources found on-site. The verification is realised for each HASS.

4.13.2.4.                   
Inspections and penalties 

The RPII is in
charge of the inspections of HASS holders. Routine regulatory inspections of
HASS licensees are part of the RPIIs annual inspection programme. The
inspection is funded by means of an annual tax linked to the authorisation.
RPII inspectors are warranted to undertake inspections at any time and can
carry out unannounced inspections if deemed warrant. Regulatory inspections of
licensees with HASS are conducted at frequencies consistent with IAEA
recommendations. All licensees with mobile HASS and industrial irradiators are
inspected annually and others are inspected from 1-3 years depending on the
category of licensee.
Inspectors are
technically qualified and competent and receive in-house and on-the-job
training in addition to attending external courses. Inspectors are also
accredited as part of ISO 17020-accreditation scheme. Inspectors in Ireland are
familiar with all licensed HASS sources in the country as well as the
container. The scope of inspection covers documentation, inventory, visual
inspection of HASS and their environment, dose rate measurements and security
measures. The inspections cover also risk assessment, radiation safety
procedure and emergency plans. RPII inspectors do not routinely take wipe tests
during inspections, but they request to see all relevant wipe test certificates
not just for HASS but for all sealed sources.
Security audits of
HASS licensees are conducted by the National Crime Prevention Unit before
issuing a licence and the findings are forwarded to the RPII for action during
RPII regulatory inspection. Breach of conducting an unlicensed practice as well
as failure to comply with licence conditions are penalised with a fine not
exceeding € 1200 per offence or imprisonment for a term not exceeding 12
months or both. These breaches and penalties have been tested in the Courts
with licensees but no cases involving HASS licensees have yet come before the
courts.

4.13.2.5.                   
Control of HASS by the holder

Visual inspections
by the HASS holders are required monthly while leak tests are required every 2
years unless an incident warrants more frequent testing. Dose rate measurements
are generally taken during use of the HASS. The regular performance of tests by
the holder is verified during inspections as the regulatory inspectors will
look at all relevant information and take copies of all relevant test results.
The control measures implemented to prevent inadequate use, unauthorized
access, loss or theft of the sources or their damage by fire or flooding is
part of the licensing process and is also routinely checked during inspections.

4.13.2.6.                   
Sources holders’ training

The content and
the preparation of the training program of the HASS holder staff is defined by
the holder. The RPII Inspectorate would expect the training to cover radiation
protection, risk assessments, safety procedures and emergency planning. Under
the Irish legislation, the training must be repeated at regular intervals but
no time period is specified. The training sessions are recorded; all such
training must be documented by the holder and go onto the staff training
record. However, no comprehension test is organized. The performance and
efficiency of the training sessions is verified by checking training records
and looking over the course content during inspections.
All the categories
of workers (management staff, exposed and non-exposed workers) receive the same
training covering radiation protection, specific requirements for safe
management of source, possible consequences of loss, theft, inadequate use or
damage of sources and prompt notification.

4.13.2.7.                   
Identification and marking of HASS

The documentation
accompanying the HASS systematically complies with the requirements of the
article 7 of the HASS Directive. Licensees forward the relevant documentation
at licensing stage and at subsequent renewals and amendments. During
inspections the relevant paperwork is checked against the HASS sources found
on-site and source number/pig-tail numbers are physically checked on-site. To
the RPII’s knowledge, there is no HASS in Ireland without identification
number.
Ireland having no
national HASS manufacturer, all the HASS are imported. Co-60 sources used in
industrial irradiators in Ireland come with a 20 year working life. Other HASS
sources don't have a recommended working life.

4.13.2.8.                   
Transfers of HASS

Source transfers
can only take place following approval being granted by the RPII in Ireland. It
is an offence to transfer a source without prior authorisation from the RPII.
In case of international transfer, the authority is informed by national
competent authority of the recipient country. No situation with a source lost
or out of control due to unrecorded transfer has been encountered in Ireland.

4.13.2.9.                   
Long-term management of disused HASS

The national
regulatory framework does not define a limited use life for HASS. Under the
Irish regulatory system a licence condition states that once a source becomes
disused it is either returned to the supplier or placed in a recognized
installation or transferred to another licensed user without undue delay. This
condition applies to all sources including HASS, but HASS are also covered by
additional licence conditions in relation to upkeep of take-back agreements and
the provision of adequate finances for ultimate disposal in the event of
bankruptcy. These latter conditions do not apply to all sealed sources. 
The preferred
national strategy for the long-term management of HASS is the return to the supplier.
At the end of their useful working life all HASS sources are returned to the
manufacturers in accordance with take-back agreements. HASS licensees as part
of the licensing process must forward a copy of the take-back agreement and the
financial arrangements that are in place to deal with the HASS sources. This
take-back agreement and financial arrangement must be confirmed annually by the
licensee to the RPII and any changes highlighted. Compliance with these
conditions is checked annually by the inspectors.

4.13.2.10.               
Security measures

As part of the
implementation programme, the RPII, in conjunction with the National Crime
Prevention Unit of An Garda Síochána (the Irish Police Force), have undertaken
security audits of all HASS licensees and have overseen improvements in
security where required. The security requirements foresee fences, recorded
control access, locked premises and locked source as well as fire detection.
Video surveillance is available only at holder’s premises during storage.

4.13.3.                         
Detection
4.13.3.1.                   
Detection of orphan sources

A threat
assessment considering orphan sources identifies strategic locations where
orphan sources are likely to be found: metal scrap yards and harbours. In those
locations, detection equipment is available but on a voluntary basis only. The
equipment includes either portal or portable monitors at metal scrap yards and
portal monitors at harbours. Revenue and Customs have two truck mounted mobile
scanning units with radiation detection capabilities which move from port to
port. The equipment used does not need to be authorised by the RPII.

4.13.3.2.                   
Campaign for orphan sources recovery

The regulatory
framework allows for such recovery programmes but to date no campaigns have
been organised. No orphan sources have been discovered in Ireland to date and
all legacy sources are still under licence. Source inventories are checked
routinely during regulatory inspections to confirm the continued presence of
sources. 

4.13.3.3.                   
International cooperation and information
exchanges

Ireland
contributes to the IAEA Incident and Trafficking Database since 2002. Ireland
has reported to the IAEA Incident and Trafficking Database three incidents.

4.13.4.                         
Preparedness and Response
4.13.4.1.                   
Emergency plans and procedures

In 2010 the Irish
Government agreed a Temporary Operational Protocol for seized and orphan
sources which sets out responsibilities for RPII, Government departments and
key stakeholders to ensure that these sources are dealt with in a safe and
secure manner. The staff of the RPII constitutes a team if/when required,
composed of max 7-10 persons equipped with communication means, measurement
devices, individual protection equipment, shielded containers and
decontamination material. The RPII operates an on-call duty officer system
24/7, where necessary to activate the emergency response. The emergency plan
has not been initiated because no orphan sources detection or incidents has
occurred.
As part of the
licensing process HASS licensees must submit risk assessments, radiation safety
procedures and emergency/intervention plans which must be approved by the RPII.
However, there are no compulsory emergency preparedness and response
requirements for the operators of institutions where orphan sources are more
likely to be found. RPII can only recommend to such organisations that emergency
plans are put in place.

4.13.4.2.                   
Training and information of persons potentially
confronted with an orphan source

The personnel
potentially confronted with an orphan source are not trained. Under the Irish
legislation the training is only obligatory to licensees. 

4.14.                               
Italy 
4.14.1.                         
Regulatory framework with respect to HASS
4.14.1.1.                   
Regulatory authority

The Italian
legislation covers all activities related to import and export, handling, use,
storage, transport, disposal of radioactive materials, products, apparatus and
any other devices containing radioactive substances. The main legislation is:
·        
Act
no. 1860 of 31st December 1962, governing radiation sources, nuclear
installations and third party liability;
·        
Legislative
Decree no. 230 of 17th March 1995 (as amended by successive legislative
decrees), governing radiation sources, nuclear installations as well as the
radiation protection provisions for workers and the member of the public; the
Legislative Decree replaced the Presidential Decree no. 185 of 13th February
1964;
·        
Legislative
Decree no. 52 of 6th February 2007, which transposes the European Union
directive 2003/122/Euratom on the control of high-activity sealed radioactive
sources and orphan sources.
An important
feature of legally binding rules concerning safety and radiation protection in
Italy is that contravention to obligations by operators and/or users
constitutes a misdemeanour and entails a penal sanction; compliance can be
enforced by means of criminal proceedings after due process of law. 
With regard to the
licensing process, central authorizations (Cat. A) are granted with
interministerial decree issued by Ministry Economic Development, acting in
accordance with Ministry of Environment, Ministry of Interior, Ministry of
Health and Ministry of Labour, and based upon binding technical advice of
ISPRA, which entitled by the Italian legislation with the role of regulatory
body for nuclear safety and radiation protection. Coordination of licensing
process is performed by Ministry Economic Development. 
Local
authorizations (Cat. B) are granted by the Prefect, for industrial and research
use of radioactive sources or by local health authority, as identified by the
Region law for medical use of radiation sources.
Inspection
activities are performed by ISPRA and other authorities such as Labour
Inspectorate or local Health bodies.
Ministry of
Economic Development / ISPRA is the organization designated as the main
competent authority in accordance with the HASS Directive. They are responsible
for authorization, transfers, records, inspections and report on experience.
The following
authorities have also competences:
·        
Prefectures
(Ministry of Interior) / Local Health Authorities. They are responsible for
authorization, transfers, records and inspections.
·        
Prefectures
(Ministry of Interior). They are responsible to issue the local radiological
emergency preparedness and response plan in relation to radioactive (also non
HASS) and orphan sources.
·        
Ministry
of Environment (together with Ministry of Economic Development). They are
responsible for report on experience.
·        
Ministry
of Foreign Affairs in coordination with Ministry of Interior.
They are responsible for orphan sources and international cooperation.
·        
Ministry
of Foreign Affairs. It is responsible for international cooperation and information
exchange.

4.14.1.2.                   
Legislative framework

The HASS directive
has been transposed into national legislation in Italy by Legislative Decree
no. 52/2007, on 6 February 2007. Financial security provisions for orphan
sources are not transposed because of lack of economic resources.
Italian
legislation follows the activity levels in the Annex 1 of HASS directive. If
the activity of a HASS falls below HASS directive level it is covered by
provisions of non-HASS established in the Italian legislation. Existing high activity
sources at time of transposition of HASS directive are also covered by
provisions of Legislative Decree no. 52/2007. A source is excluded from
regulatory control when its activity is below the exemption levels laid down in
Legislative Decree no. 230/1995.

4.14.2.                         
Prevention and Deterrence
4.14.2.1.                   
Authorization for practice with HASS

All relevant
topics are being taken under consideration for giving the authorisation in
Italy: 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 that have been implemented to prevent damage
of HASS by fire, flooding, etc.
It has happened
that authorization of a HASS has been refused because of missing authorization
of the facility.

4.14.2.2.                   
Records keeping and updating

HASS holders are
required to keep records of all HASS under their responsibility. The HASS
holder provides the authority with the recorded information at the acquisition
time, when the holder no longer holds the source and periodically (each 3
months). In addition specific provision of the Italian legislation prescribes
that a report of all sources hold during the year shall be sent to the
competent authority at the end of the year. The maximum delay to provide the
information is 90 days. 

4.14.2.3.                   
National inventory

The recorded
information is used to establish a national inventory of authorised HASS
holders and the HASS they hold. Up to now the information was provided to the
authority only in written copy. Data (all information requested in the standard
record sheet given in Annex II of the HASS Directive) will be processed into a
national electronic database (national register). 
Sources not
covered by the HASS directive are also included in the national register, but
in a separate database. The register of authorized source holders is not
available directly to customs or to police organizations.
During
inspections, the authority checks the match between the actual situation of
HASS and the information by the holder for each source.

4.14.2.4.                   
Inspections and penalties 

Inspections are
executed by ISPRA for Category A facilities, in the fields of safety, security
and non-proliferation. Local authorities execute inspections only in the field
of safety. Unannounced inspections as well as follow-up actions in case of an
incident or any other suspicious situation are organized for safety.
The inspectors
dealing with HASS are trained in their specific field, meaning in security,
safety and non-proliferation and have experience in nuclear technology.
Training regarding information concerning their potential confrontation with a
source, visual detection of sources and containers, specific requirements for
safe management of sources, possible consequences of loss, theft or inadequate
use or damage of sources and procedures for prompt notification to the
Authority and emergency responses in case of (potential) detection/accident is
provided in the field safety.
The scope of an
inspection related to HASS is related to safety and includes documentation,
inventory, contamination measurements and dose rate measurements of leakage
radiation. Special security measures are not covered. The inspections are
directly funded by the State.
In case of
breaches of the national provisions pursuant to the HASS Directive penalties of
1 to 3 month imprisonment or fines ranging from 5000 to 20000 Euro are
applicable. 

4.14.2.5.                   
Control of HASS by the holder

The competent
Authority verifies the regular performance of suitable tests by the Holder to
control the good conditions (integrity, place of use or storage etc.) of each
HASS and associated device during inspections. Leak tests are carried out by
the supplier. 
The competent
Authority is informed on the control measures implemented during authorization
process and during inspection.

4.14.2.6.                   
Sources holders’ training

The definition of
the training program of the HASS holder staff is done by the holder itself
following the Italian legislation. The training material is prepared by the
holder with the qualified experts' support. The training sessions are recorded;
verification of training is done by the holder who then usually checks through
tests/exams. However tests are not mandatory by legislation.
Training records
are checked by the Authority during inspections. The categories subjected to
training are in general terms the management staff, the radiation protection
officer and the exposed workers. Non-exposed workers are trained in radiation
protection principles.

4.14.2.7.                   
Identification and marking of HASS

Documentation
accompanying the HASS systematically includes source identification (on the
source or container), information and photographs of source design type and
information and photographs of the transport packaging. There are no HASS in
Italy without identification number or without information on the nature of the
source.

4.14.2.8.                   
Transfers of HASS

The holder
ascertains that the recipient holds the appropriate authorisation by asking a
copy of it. The authority is informed of the transfer and the transport to the
recipient in case of a national transfer. 
As far as
transboundary shipments of sealed sources and other relevant sources among
Members States of the European Union are concerned, it must be mentioned that
Council Regulation (Euratom) no. 1493/93, constitutes the legally binding act.

4.14.2.9.                   
Long-term management of disused HASS 

There is no
requirement in any regulation to define a limited useful life for HASS. There
is no encouraged national strategy regarding how to deal with HASS once the
HASS becomes disused. In practice the source is sent back to the supplier or
transferred to an authorized radioactive treatment/storage facility or stored
at holder’s premises.  
An authorized
storage facility for radioactive waste is available and disused HASS are in
principle accepted, but its capacity is limited therefore sending back to
supplier is the first implemented choice. Holders of HASS are forced to make
adequate arrangements for the long-term management of the HASS after
termination of the use because an authorisation is issued only if the long-term
management route is already specified and planned. 
Long term
management is funded by “take back” provisions incorporated into
supply contract, by fund set by the holder or by financial guarantee prepaid by
the holder to the state or competent authority. 

4.14.2.10.               
Security measures

The compulsory
security measures should foresee fences, locked premises and fire detection
systems (but not for places of use of mobile sources).

4.14.3.                         
Detection
4.14.3.1.                   
Detection of orphan sources

A threat
assessment concerning orphan sources at national level has been performed by
the competent authority. The strategic locations identified to detect orphan
sources are metal scrap yards, metal scrap recycling facilities, metallurgic
facilities, borders/customs and harbours. At all these sites detection
equipment is compulsory. Portal monitors are requested at borders/customs and
harbours. In addition also compulsory portal monitors are requested at
conventional waste management facilities. The type of detection equipment is
not imposed by the authority and it is not necessary to be authorized.
Legislative
provisions are established into Italian legislation with a view to setting up
detection apparatus measurement at the borders and at foundries or at
facilities collecting metal scrap; in many instances apparatus and/or surveillance
procedures are already in place. Ports and borders also have measuring
equipment. 

4.14.3.2.                   
Campaign for orphan sources recovery

Recovery campaigns
have already been organized in Italy through systematic analysis of the
historical records available at the authority and investigations in the former
holders’ records. There is a general lack of budget and a general lack of
competent staff, so no frequency for these campaigns has been predefined.
Recovery campaigns
have been based on type of sources, use of sources and particular industrial
sources. The recovered sources have been returned to supplier/manufacturer, if
identified or have been transferred to authorized storage/disposal facility.
Italy is convinced that organizing of recovery campaigns is the best method to
recover orphan sources.

4.14.3.3.                   
International cooperation and information
exchanges

Italy has
communicated on international level cases of discovery to IAEA and EU and cases
of illicit trafficking to IAEA. It contributes to the IAEA Incident and Trafficking
Database.

4.14.4.                         
Preparedness and Response
4.14.4.1.                   
Emergency plans and procedures

There is no
national radiological emergency response plan in place in relation with orphan
source or HASS. According to Italian legislation, there are only local
radiological emergency response plans issued by the Prefectures.
An emergency team
is available to intervene 24/7 in case of emergency with an orphan source or
HASS. Responsibility is on the Ministry of Interior (national fire brigade) in
case of radioactive risk response, providing subsequent activation of various
skill levels, activated by the National Operation Centre. Experts are available
in ISPRA emergency centre shift. Available equipment is communication devices,
measurement devices and individual protection equipment and decontamination
material.
There are
compulsory emergency preparedness and response requirements for HASS holders in
place. The emergency response plans and/or procedures must be part of the
documents submitted by the holder to obtain the authorization. There are no
compulsory emergency preparedness and response requirements for the facility
operators of institutions where orphan sources are more likely to be found.
According to
emergency plans, the following responsibilities are set: emergency services
deal with mobilization of responders, security of site and source and control
of the contamination of the site after source removal. The authority is
responsible for the first instructions to public. The qualified expert is
responsible for radiological assessment and contamination control after source
removal. Finally, another entity is in charge of transport of the source.

4.14.4.2.                   
Training and information of persons potentially
confronted with an orphan source

An extensive and
adequate training and information plan is mandatory for all people who could
potentially be confronted by orphan sources. For transport and facilities, the
training includes all the relevant topics: potential confrontation with a
source, visual detection of sources and containers, radiation protection
principles and specific requirements for safe management of sources. The
training courses are obligatory and documented and are regularly repeated.
Comprehension tests are organized. The training sessions include practical
exercises. 

4.15.                               
Latvia
4.15.1.                         
Regulatory framework with respect to HASS
4.15.1.1.                   
Regulatory authority

The
primary Regulatory authority in the field of safety and security of ionising
radiation sources in the country is the State Environment Service (VVD), within
which a Radiation Safety Centre (RDC) is organised. Its main functions related
to HASS include licensing, supervision and control. These functions are not
limited to HASS, but cover all ionising radiation sources. Other functions of
VVD and RDC include search, identification and evaluation of unknown or
unregistered radiation sources on the territory and to organise the disposal of
orphan sources when the legal person responsible for the source cannot be
identified.
The
regulating function is exercised by the Ministry of Environmental Protection
and Regional Development. This ministry is also responsible for funding the
disposal of orphan sources.
The
State Company Latvian Environment, Geology and Metrology Centre is the manager
of radioactive waste in the country. It is running the repository Radons. This
repository accepts HASS only for temporary storage (near surface disposal). A
final solution for disused HASS needs to be developed in the country.
Other
main organisations involved with the regulatory management of HASS include the
Security Police and the State Police (inspections of security aspects and
orphan source detection), the Customs (transfer and record keeping) and the
Fire & Rescue Service (orphan source detection and approval of emergency
response plans of the licensees).

4.15.1.2.                   
Legislative framework

The
legislative framework in the country is based upon the Law on Radiation
Safety & Nuclear Safety of 26th October 2000, as amended. Several
regulations foresee in its implementation. 
The
Instruction 12 Regarding Actions of Responsible Institutions in the Event of
Finding a Substance or Object of Unknown Origin if it is Suspected that it
Contains Explosive, Radioactive, Dangerous Chemical or Biological Substances,
as well as if Indications of Terrorist Attack are Detected (5th August
2008) complete the legislative framework with respect to HASS. This framework
regulates the use of all types of radiation sources, including HASS. The same
definition and related radiological criteria are being used for defining HASS
as those used in the Directive, although in practice the sources are classified
according to their actual activity. Therefore, the specific requirements for
HASS do not apply anymore to sources of which the activity is decreased below
the high activity levels. 
The
main differences between HASS and non HASS are to be found in records keeping
and reporting. Requirements for users, authorisation regime, inspection,
training, financial security are similar for HASS and non HASS.

4.15.2.                         
Prevention and Deterrence
4.15.2.1.                   
Authorization for practice with HASS

Before
issuing an authorisation 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. Authorisation is only granted after all relevant information is
received and has been judged as being adequate by the Regulatory Authority.
The
license for use does not cover storage. The holders must notify the authority
within 10 days after the end of the operations with the HASS. When the source
is not used for 3 months, the holder must request a license modification
authorising the storage of HASS.
All
HASS are imported with a recommended working lifetime for the source, which
depends on the type of source and the use of the source.

4.15.2.2.                   
Records keeping and updating

All
HASS holders are required to maintain records of the HASS under their
responsibility. A written copy of these records is to be sent to the Regulatory
authority at the time of acquisition of the source. From then on a yearly
update of these records needs to be sent before January 31st through an annual
report of the licensee. The Regulatory authority is furthermore informed of all
important modifications related to HASS (modification of the use or storage, end
of use, transfer, etc.). 

4.15.2.3.                   
National inventory

The information
received through these records is used to maintain an electronic national
inventory (RAIS – IAEA) which is covering all radiation sources. The
Regulatory authority does not have indications that unrecorded HASS are present
in the country. HASS decayed below the HASS levels are not accounted in the
inventory. The national register is available to law enforcement authorities
(police and customs) at their request.

4.15.2.4.                   
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 and by the
Security Police (in relation with security issues). As a general rule,
inspections are announced to the licensee and come with a frequency of 4 per
year for HASS. In addition, inspections are organised as part of follow-up
actions after incidents or accidents. There are no unannounced inspections.
Inspections cover all relevant items, except for the verification of security
measures. The inspections are funded by the State. Inspectors receive training
in all relevant fields, including practical experience in metrology and the necessary
equipment for performing an inspection is available.
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
from €30 to €7000.

4.15.2.5.                   
Control of HASS by the holder

Regular testing by
the licensee of safety and security performances are required by the Regulatory
Authority. Reports on the results are systematically transferred to the
Regulatory Authority. Safety tests of HASS include visual verification, dose
rate measurements and leak tests. These leak tests are limited to wipe tests on
the source container once a year. The test performance is controlled during
inspections.

4.15.2.6.                   
Sources holders’ training

HASS
holder’s staff requires training, which is defined by the Regulatory
authority in combination with training organisation recognised by the authority
for this purpose. A comprehension test is organised at the end of the training.
Radiation workers have to repeat this training every 5 years.

4.15.2.7.                   
Identification and marking of HASS

HASS need to be
systematically accompanied by the necessary documentation. This documentation
contains all relevant information, except the information and photographs of
the transport packaging.

4.15.2.8.                   
Transfers of HASS

All HASS are individually
licensed and in case of transfer of HASS the Regulatory authority is informed
of it by the fact that authorisations and permits have to be requested for
transfer and transport. In case of a national transfer, a license needs to be
requested by the recipient of the source and in case of an international
transfer, the Competent Authority will be contacted by their counterparts of
the country of the recipient. The holder transferring a HASS also needs to
verify that the recipient holds a valid authorisation for the possession of the
source. No cases where HASS got out of control during transfer are known to the
Regulatory Authority.

4.15.2.9.                   
Long-term management of disused HASS 

The recommended
working life, generally defined by the source manufacturer, is being made
official by the Regulatory authority through the authorisation for use of the
source. For most sources and types of applications, this recommended working
life is 15 years. Currently an authorisation is only granted if the long-term
management route of the sealed radioactive sources is already specified and
planned. The country’s policy on disused sources gives priority to
returning the disused source to the supplier. If not possible, the disused
sources should be considered as radioactive waste and be transferred to an
authorised waste treatment or storage facility. The re-use of the source for
another application is only considered as last possibility. 
The country
disposes of an interim storage facility for HASS, but no final disposal
solution exists yet.  The long-term management of HASS is funded through a tax
or through take-back provisions incorporated in the supply contracts. 

4.15.2.10.               
Security measures

Regulation n° 508
contains all requirements for physical protection as a function of the category
of the sources (IAEA categorisation is used). For category 1 and 2 sources, a
physical protection plan has to be elaborated by the user, which has to be
accepted by RDC and the security police. In some category 3 and 4 installations
not all requirements are implemented due to the financial situation of the
users. In category 1 and 2 installations this is however not the case.
Verification of the physical protection situation is part of the normal
inspections carried out by RDC.

4.15.3.                         
Detection
4.15.3.1.                   
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,
border crossings, harbours and airports. The bigger scrap metal installations
(> 100,000 ton/y) currently require the availability of portal monitors as
well as portable radiation detectors. These devices are calibrated every 2
years. The personnel of these installations occupied in these radiation
measurements require a specific training course every 5 years. They need to
have emergency procedures related to the detection of orphan sources and some
of these installations have a temporary storage place for these sources. For
smaller installations, no radiation monitor is required. In conventional public
waste dumps, portal monitors are available. The border crossing points are all
equipped with portal monitors. 
In the Riga
Freeport the border crossing points in the harbours are only partly covered
with well working monitoring equipment. At airports, this detection equipment
is not mandatory. In addition to these, the Regulatory authority has available
a mobile radiometric laboratory and the customs have a cargo inspection system.


4.15.3.2.                   
Campaign for orphan sources recovery

Using the historic
records available at the authorities, the suppliers and the licensees, and
using the results of the site inspections, several sources at risk have been
transferred to the waste storage facility during the 1990’s. No other
specific campaigns have been organised since. Today recovery of orphan sources
is dealt with on a case by case basis after notification of the existence of an
orphan source through detection. These cases are financially taken care off by
the State.

4.15.3.3.                   
International cooperation and information
exchanges

Latvia is actively
participating in international cooperation and information exchange, mainly
through the established IAEA channels. The country has been contributing to the
IAEA Incident and Trafficking Database (ITDB) since 2004. 

4.15.4.                         
Preparedness and Response
4.15.4.1.                   
Emergency plans and procedures

Latvia has a
general emergency response plan in operation, also applicable in the case of
radiological emergencies. 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 approved by the local municipality and by the
State Fire and Rescue Service.
In case of
emergencies involving sealed radioactive sources or orphan sources, the
Regulatory authority has an emergency team available to intervene 24/7 with
full radiological intervention equipment available. Up to now the national
emergency plan has not been initiated in Latvia in relation to situations
involving HASS or orphan sources.

4.15.4.2.                   
Training and information of persons potentially
confronted with an orphan source

Since January 1st,
2011, an extensive and adequate training and information plan is mandatory for
all people who could potentially be confronted to orphan sources at the level
of the workers and at the level of the management. These training sessions are
repeated every 5 years. There is a comprehension test organised and the
Regulatory authority is organising a follow-up of the certificates. The
emergency trainings include also practical exercises on identification of
sources of ionising radiation.

4.16.                               
Lithuania 
4.16.1.                         
Regulatory framework with respect to HASS
4.16.1.1.                   
Regulatory authority

The Authorities
designated in accordance with the HASS Directive are the Radiation Protection
Centre (RPC) and the State Nuclear Power Safety Inspectorate (VATESI). Both
these organizations are competent/ responsible for the implementation of the
HASS Directive. The Radiation Protection Centre (RPC) is a competent authority
under the Ministry of Health in field of radiation protection (except nuclear
facilities). Its main responsibilities are connected with control of
radioactive sources: keeping the registry of sources of ionizing radiation,
investigation of cases of illicit trafficking of radioactive material, decision
making, control and supervision of users of radioactive sources. The required
license for any activities with sources is issued by the RPC. RPC has the right
to suspend or withdraw the license, when the licensee does not follow the
licensing conditions.
RPC maintains the
State Register for Sources of Ionizing Radiation and Occupational Exposure
(Register). All necessary data is present in the Registry (annual inventory of
the sources, installation of new sources, decommissioning and disposal of the
used sources) for all license holders. All licensees have possibility to review
(no rights directly perform any changes) their own information stored in the
Register: licenses, their annexes, possessed sources, workers, annual doses of
workers, inspection results, non-compliances which were set during inspections,
the terms of implementation. Also on behalf of a bilateral treaty; the Customs
Department provides weekly information on all the sources that were imported to
or exported from Lithuania and information about legal persons that carried out
these procedures.
VATESI is the
regulatory authority for nuclear safety and radiation safety concerning
practices with sources in the nuclear energy sector. VATESI sets legal
requirements for, authorises and exercises the state supervision of practices
with sources in the nuclear energy sector.

4.16.1.2.                   
Legislative framework

Lithuania has
developed an effective control system for sources of ionizing radiation, having
a great regard to high activity Cat. I-III sources (HASS). The established
system is in line with IAEA recommendations, Code of Conduct on the Safety and
Security of Radioactive Sources and requirements of the appropriate legislation
of the European Community.
Main pieces of
legislation and regulation related to usage, transportation and security of
HASS are the following:
·        
Law on Radiation
Protection - establishes
general principles of radiation protection, responsibilities of state and other
institutions and licensees as it regards safety and security of sources;
·        
Regulations on the
Import, Export, Transit and Transportation of Radioactive Materials and
Radioactive Waste -
establishes the order of issuing permits for import, export and shipment of
sources inside the country;
·        
Regulations on the
Control of High Activity Sealed Ionizing Radiation Sources and Orphan Ionizing
Radiation Sources -
legitimated the requirements of The Council Directive 2003/122/Euratom of 22
December 2003 On The Control Of High-Activity Sealed Radioactive Sources And
Orphan Sources;
·        
Regulations On
Physical Security of Sources of Ionization Radiation - defines requirements of technical and
administrative security measures;
·        
Regulations on the
Risk Categories of the Ionizing Radiation Sources and Methodology of Assigning
to the Risk Category -
defines risk categorization methodology according to the IAEA categorization
and Code of Conduct on the Safety and Security of Radioactive Sources
recommendations.
The HASS Directive
is fully transposed in the national regulatory framework and the date of
enactment was the 23/12/2005. The act is named Control Regulations of High
Activity Sealed Ionizing Radiation Sources and Orphan Ionizing Radiation
Sources, approved by the Ministry of Health. The same definition and activity
levels are used in the national regulatory framework as in the HASS Directive.
In accordance with
Lithuanian regulations in the case when activity of the HASS falls below the
defined high-activity level due to the radioactive decay the radioactive source
is still covered by the HASS regulation. Only when its activity level is below
the exemption level specified in the Directive 96/29/EURATOM the source is
excluded from the regulatory control.

4.16.2.                         
Prevention and Deterrence
4.16.2.1.                   
Authorization for practice with HASS

All topics are
being taken under consideration before giving an authorization for the use of a
HASS: 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 disused sources;
control measures to prevent inadequate use, unauthorized access, loss or theft
of the HASS and control measures have been implemented to prevent damage of
HASS by fire, flooding, etc. There have been no cases in Lithuania when
regulatory authority refused an authorization for the use of a HASS.

4.16.2.2.                   
Records keeping and updating

The HASS holder
keeps records both electronically and in written copy under his responsibility,
which is sent to the competent authority, respecting the time delay of 10
working days. The HASS holder provides the RPC with the recorded information in
the case when the holder no longer holds or uses the source or/and when he no
longer uses any other source. In addition annually (by the 31st
January of the following year) the results of the physical inventory are
notified by the holder to the RPC.

4.16.2.3.                   
National inventory

The recorded
information is used to establish a State Register of Sources of Ionising
Radiation and Occupational Exposure, established in 1999 (electronic database).
All the HASS on Lithuanian territory are recorded in the State Register.
Information recorded in the State Register is in accordance with the Annex II
of HASS Directive. The sources not covered by the HASS Directive are also kept
in this Register. Holders’ records are available for inspection by police
organizations and customs under official request. During inspections, the
Authority checks the match between the actual situation of the HASS and the
information recorded by the Holder. The verification is made for each HASS.

4.16.2.4.                   
Inspections and penalties 

License holders
are inspected on a routine and special basis, and are being prioritized
according to the risk category of sources. Both announced and unannounced
inspections are carried out. RPC has a programme for inspecting licensees,
focusing these inspections on safety (Sf) and security (Sc) of sources
(especially HASS).
The RPC inspectors
are trained in Sf and Sc in the following fields: practical experience on
nuclear metrology; information concerning potential 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 equipment of the inspectors
consists of individual dosimeters and dose rate meters; contamination
detectors; list of pictures of typical sources and containers. The inspections
are funded directly by the State.
RPC examines cases
of administrative violations foreseen in articles of The Code of Administrative
Violations. Also there are measures of imprisonment to 10 years foreseen in
Lithuanian Penal Code in case of illicit trafficking or breaches which has
harmful consequences. Fines can also be applied.

4.16.2.5.                   
Control of HASS by the holder

In accordance with
the Lithuanian regulations the holder has to perform regularly the tests to
control the good conditions of each HASS (integrity, place of use or storage,
etc.). The holder’s testing usually includes the visual verification,
leak tests and dose rate measurements. The RPC is regularly informed by the
holder on the control measures implemented to prevent inadequate use,
unauthorized access, loss or theft the sources or their damage by fire,
flooding, etc. Such information is provided by the holder during the
authorization process and in addition through regular reporting by the Holder,
as required by the RPC. Additional control of the measures implemented is
performed in the course of RPC inspections. 

4.16.2.6.                   
Sources holders’ training

The training
programme of the HASS holder staff is defined by the Regulatory authority. The
training material is prepared by an organization recognized by the Regulatory
authority. After each training session the comprehension tests are organized by
the training organization. The results of examination are recorded in the
examination protocol. During their inspections the RPC inspectors verify that
the holder's employees passed the training and they have the radiation
protection certificate. The performance and efficiency of the training
performed is also carried out during inspections checking the knowledge of
holder's staff. 

4.16.2.7.                   
Identification and marking of HASS

The documentation
accompanying a HASS includes all the documentation. The information on
identification source containers and transportation packages is checked
visually. 
The manufacturer
usually recommends a limited working life: depending on type of source, the
recommended working time ranges from 5 to 15 or more years. After this, the
working life period of source could be prolonged by RPC for one more year after
evaluation of the state of HASS.

4.16.2.8.                   
Transfers of HASS

In case of HASS
transfer the holder has to ascertain that the recipient holds an appropriate
authorization. This is done by request of a copy of such authorization. The
Regulatory authority is informed of individual transfers of HASS from records,
by issuing an authorization for the transfer, for the transport and to the
recipient. Such approach is used for the national and international transfers. 
The export/import
transfers within the EU countries are performed following the provisions of the
Council Regulation (Euratom) No 1493/93 of 8 June 1993 on shipments of
radioactive substances between Member States. 
For the shipments
from non-EU countries the appropriate application should be submitted to the
RPC in accordance with the provisions of the appropriate legal acts of
Lithuania. Lithuania has never encountered a situation with source lost or out
of control because of unrecorded transfers.

4.16.2.9.                   
Long-term management of disused HASS 

The national regulatory
system does not define a limited useful life for HASS. The preferred strategy
for the long-term management is the return to the supplier, then the transfer
to authorized radioactive waste facility and transfer for reuse to another
authorized holder.
There is a
national authorized storage facility for radioactive waste that accepts disused
HASS. Its capacity is adapted to the potential amount of disused sources. After
termination of its use, the holder should dispose of the disused HASS in
accordance with the legislation and is obliged, to transfer for conditioning
the improper or disused sources of ionising radiation.
The Holder is
forced to make adequate arrangements for the long-term management of the HASS
due to the fact that the authorization is issued only if the long-term
management route is already specified and planned. Alternatively, the import of
a new source is conditioned on its re-export.
According to the
Law on Radioactive Waste, sealed sources of ionizing radiation may be imported
into the Republic of Lithuania if after their use it is intended to return them
to the supplier of the sealed sources of ionizing radiation. The recipient of a
sealed source of ionizing radiation enters into a contract with the radioactive
waste manager on the management of the sealed source of ionizing radiation in
case the sealed source of ionizing radiation cannot be returned to its
supplier. The recipient of a sealed source of ionizing radiation obtains
suretyship insurance in the amount specified in the contract with the
radioactive waste manager for the services, except in the cases stipulated in
the legal act.
Lithuania has
never encountered a situation dealing with disused source without any long-term
management solution. The long-term management of the disused HASS is funded by
take-back provisions incorporated in the supply contract and in funds set by
the holder. All used HASS must be returned to manufacturer or transferred to
radioactive waste manager. So far Lithuania has not encountered any financial
problems in the long-term management of disused HASS.

4.16.2.10.               
Security measures

Adequate security
requirements are implemented, depending on risk category and the planned use of
the source. Technical and administrative physical security measures are in
place in the facilities using high activity sources of ionizing radiation.
Amount of technical and administrative physical security measures depends on
the source risk categories. Before being entrusted with the physical protection
of the sealed sources of Cat. I-III or being accepted to work involving
shipment of sealed sources of Cat. I-III the trustworthiness check of the
person must be arranged.

4.16.3.                         
Detection
4.16.3.1.                   
Detection of orphan sources

The Authority has
performed a threat assessment concerning the orphan sources. All locations
identified in the questionnaire to detect orphan sources have been considered
strategic with the exception of transit hubs. The controls are compulsory in
all the strategic locations in accordance with the Lithuanian Regulations on
the control of high-activity sealed radioactive sources and orphan sources
(developed in accordance to the Euratom Directive 2003/122 of 22 December
2003).
State border
control points with non EU countries (airport, port, rail and road) have
stationary and portable detection equipment (fixed radiation portal monitors,
personal radiation detectors, hand-held gamma/neutron search detectors,
hand-held radionuclide identification devices). However the type of detection
equipment is not imposed by the Authority. Detection equipment is not
compulsory in the conventional waste management facilities but searching
campaigns for orphan sources are performed by RPC there too.
RPC encourages the
natural and legal persons who are engaged in activities with potential risk to
encounter the orphan radioactive sources (the buyers, sellers of antique, etc.)
to acquire the detection equipment on the voluntary basis. RPC pays great
attention to education of the persons, who potentially might encounter an
orphan source, prioritizing preparedness for radiological emergency situations.


4.16.3.2.                   
Campaign for orphan sources recovery

The regulatory
framework ensures that campaigns to recover orphan sources from past activities
are organized. RPC continuously organizes and conducts orphan sources detection
and recovery campaigns according to approved annual programmes. The recovery
campaigns in Lithuania have been mostly focused on the types of the sources and
the particular industrial sectors where probability to run into an orphan
source is rather high.
The orphan sources
searching campaigns focus on sites with the highest risk (e.g. buildings of
former Institute of Oncology, aircraft repair plant, missile base, etc.). They
include former Soviet military bases, factories, conventional waste management
facilities and other facilities and places in the territory of the Republic of
Lithuania.
About 20 persons
are devoted to the organization of recovery campaigns. There is a specific
budget dedicated to recover orphan sources. The recovery campaigns in Lithuania
are organized approximately every 3 years and involve around 10 facilities,
following the Regulations established by the State. Private sector is not
involved in the recovery campaigns. Recovered sources are returned to the
supplier if identified. Otherwise they are transferred to the authorized
radwaste facility. There is a financial strategy covering intervention costs
that is supported by the State.
The best method to
recover the greatest number of orphan sources is organizing the campaigns and
using or installing radiation detection equipment in strategic locations.
According to RPC the most cost effective type of recovery campaigns is by means
of public announcements. Public awareness rising on this topic has generated
positive results: RSC annually receives calls from public about suspicious
objects found. In many cases their information was correct and sources were
found in the reported locations.

4.16.3.3.                   
International cooperation and information
exchanges

Lithuania
contributes to the IAEA Incident and Trafficking Database since 1996.
Information is transmitted through VATESI which is the national contact point.

4.16.4.                         
Preparedness and Response
4.16.4.1.                   
Emergency plans and procedures

Lithuania has a
national radiological emergency response plan in place in relation to HASS and
orphan sources. The emergency preparedness and response requirements are
compulsory for HASS holders and the appropriate response plans and procedures
are approved by the RPC. The same requirements are compulsory for those
institutions where orphan sources are more likely to be found. During the
inspections, the emergency response plans are evaluated by inspectors of RPC.
The first
responders to the emergency situation are the Units of Fire and Rescue
Department who are in charge 24/7. If expertise is needed, the experts or
consultants are invited from RPC, whose availability is also ensured 24/7. The
equipment available includes the dedicated vehicles (mobile laboratories),
communication, measurement devices, individual protection equipment, shielded containers
and necessary decontamination materials. The Radioactive Waste Management
Agency is responsible for management of orphan sources and it owns shielded
containers and decontamination materials.

4.16.4.2.                   
Training and information of persons potentially
confronted with an orphan source

The personnel
confronted with an orphan source are trained and the training is addressed to
managers and workers in all categories (emergency, transport, facilities). The
content of the course covers all the relevant items. The training courses are
obligatory according to regulations, documented, and regularly repeated at a
frequency of 5 years. Once per year, briefings at the workplace are performed
by the person responsible for radiation safety. Comprehension tests are organized
and the training sessions include practical exercises. The specific facilities,
devices and materials are used for these exercises. They include portal
detectors, hand-held instruments, shielding, long arm pliers, etc.

4.17.                               
Luxembourg 
4.17.1.                         
Regulatory framework with respect to HASS
4.17.1.1.                   
Regulatory authority

The department of
radiation protection (DRP) within the Ministry of Health is actually charged
with the protection of the population against the hazards of ionizing and
non-ionizing radiation. It is in charge with the preparation of laws,
regulations and decrees in the field of radiation protection and nuclear
safety. It is responsible for the formalities within the licensing procedure.
DRP has been designated as the competent national authority charged with
carrying out the missions provided for in the HASS Directive.
All activities and
projects of the DRP are financed via state budget, allocating predefined
credits on a yearly basis. 

4.17.1.2.                   
Legislative framework

In 1963, a
framework law was enacted on the Protection of the Public against the Hazards
of Ionizing Radiation. It is the legal basis for executive regulations which
sets out the basic principles regarding radiation protection and nuclear
safety. The executive regulations are regularly amended with the EU Directives
on radiation protection and nuclear safety.
However being a
non-nuclear country, Luxembourg does not dispose of very detailed regulations
on nuclear matters which would cover all aspects related to nuclear activities.
A list with relevant laws and regulations, including the ratification of laws
for international conventions, is given hereafter:
Laws
•           Law
of 25 March 1963 concerning the protection of the population against the
dangers arising from ionizing radiation.
•           Law of 21 November 1980 concerning
the organization of the Directorate of Health.
•           Law of 28 March 1984 concerning the approbation of
the agreement between the government of the Grand Duchy of Luxembourg and the
government of the French Republic concerning the information exchange in case
of an incident or accident which might have radiological consequences, signed
in Luxembourg on 11 April 1983.
•           Law of 19 March 1997 concerning the approbation of
the Convention on Nuclear Safety, adopted in Vienna on 20 September 1994.
•           Law of 28 July 2000 concerning the approbation of the
Convention on Assistance in the Case of a Nuclear Accident or Radiological
Emergency, adopted in Vienna on 26 September 1986.
•           Law of 28 July 2000 concerning the approbation of the
Convention on Early Notification of a Nuclear Accident, adopted in Vienna on 26
September 1986.
•           Law of 12 June 2006 concerning the
creation of the rescue services agency
•           Law of 27 April 2006 concerning the approbation of
the agreement between the government of the Grand Duchy of Luxembourg and the
government of the Kingdom of Belgium concerning the information exchange in
case of an incident or accident which might have radiological consequences,
signed in Eischen on 28 April 2004.
Regulations and
Decrees
•           Grand-ducal
regulation of 27 November 1987 concerning the admissible levels of
radioactivity in foodstuffs.
•           Grand-ducal regulation of 11 August 1996 concerning
the provision of information to the population on the applicable measures for
the protection of public health and on the conduct to be adopted in the event
of a radiological emergency.
•           Grand-ducal regulation of 14 December 2000 concerning
the protection of the population against the dangers arising from ionizing
radiation.
•           Grand-ducal regulation of 6 May 2010, defining the
specific missions, the composition, organization and operation of the
department of civil protection of the rescue services agency.
•           National emergency response plan in case of an
incident or accident in the nuclear power plant of Cattenom or in case of any other
radiological or nuclear event (adopted by the Government on 2 December 1994).
The Council
Directive 2003/122/Euratom of 22 December 2003 on the control of high-activity
sealed radioactive sources and orphan sources (HASS) was fully transposed into
national law on 21 July 2006 by amending the Grand Ducal Regulation of 14
December 2000 on the protection of the population against the dangers of
ionizing radiation.

4.17.2.                         
Prevention and Deterrence
4.17.2.1.                   
Authorization for practice with HASS

The DRP ensures
that before issuing authorization for any practice involving a high activity
source as defined in the Directive all relevant provisions of the Directive are
in place, namely safe management of the source, security measures, emergency
procedures, training, records keeping and transfers, etc. The Minister of
Health may suspend or withdraw a license when the licensee contravenes the
Regulation in force or the conditions of the license. The established practice
is to limit licenses for holding, storing and using radioactive materials to 10
years.

4.17.2.2.                   
Records keeping and updating

Facilities have to
hold a register of all sources used or stored on their premises with indication
of their exact respective location. Licensees have to notify the DRP of any
modification of their inventory.

4.17.2.3.                   
National inventory

The DRP have
monitored and recorded in a national inventory in form of a database each
individual sealed source active above the exemption level. The database
contains information about the type, activity and registration number of the
source, its localization and a reference to the corresponding license.

4.17.2.4.                   
Inspections and penalties

Licensed
facilities are inspected at regular intervals by inspectors of the DRP. These
periodic inspections focus on the radiological protection of the workers and
the physical protection of the sources. The licensee has to demonstrate that
internal procedures concerning the management of radioactive substances exist,
are adequate and correctly applied. Inspectors of the DRP are further
attributed with the legal power of police officers. Inspections are conducted
at least once per year in all nuclear medicine and radiotherapy centres, and in
around 50% of the other facilities licensed to use radioactive sources.
Penalties are
defined by the Law of 25 March 1963 and comprise fines and imprisonment between
8 days to 1 year. 

4.17.2.5.                   
Control of HASS by the holder

A licence holder
is fully responsible for the respect of all regulatory provisions concerning
the safe management of their radioactive sources and if necessary interim
storage of waste, as well as the organisation of the shipment to a foreign
waste management storage in accordance with the applicable regulations. Leakage
tests of the sealed sources are mandatory in case of an incident involving the
sources and at the latest when the source is 10 years in use. 

4.17.2.6.                   
Sources holders’ training

The holder is
responsible for taking the appropriate steps to optimize all exposure to
ionizing radiation, to supervise the working conditions in the controlled and
supervised areas, to implement the individual monitoring and the monitoring of
the working place, to establish written procedures and  instructions for the
exposed workers, to appoint a qualified expert or assign persons responsible
for the physical control, the safety and the security of the equipment and the
radioactive source and to give appropriate training to the exposed workers on
all relevant issues in radiation protection.

4.17.2.7.                   
Identification
and marking of HASS

HASS is
systematically accompanied by the necessary relevant documentation provided by
the producer. 

4.17.2.8.                   
Transfers of HASS

All radioactive
sealed sources have to be imported from other countries, mainly from other
European member States. In line with the regulation in force, each import and
installation of a sealed source is submitted to a licensing procedure. This
also applies to older sources not yet covered by these new regulatory
provisions. Before the shipment is scheduled sources are stored at the users'
premises. Only licensed carriers are allowed to transport radioactive materials
in quantities above exemption level. For the transfer of radioactive sources,
the EU Council Regulation of 8 June 1993 on shipments of radioactive substances
between Member States is applicable.

4.17.2.9.                   
Long-term management of disused HASS 

As part of the
licensing procedure, the applicant must have a written commitment from the
foreign supplier, where the latter agrees to take back the source if disused.
If it turns out that the supplier is unable to respect his commitment, e.g. in
case of bankruptcy, the user or holder is obliged to take all necessary
administrative steps to send his disused source to any other supplier of
radioactive sources or foreign waste management facility. 
Luxembourg has put
in place a system under which the supplier is obliged to take back all sources,
including when the user company becomes insolvent or goes out of business,
while the company has to take out insurance to cover the risks of recycling the
sources should it become insolvent. In order to anticipate any unforeseen
situation in which the abovementioned guarantees were insufficient; Luxembourg
has tasked the DRP with guaranteeing secure management and financing any
necessary measure, as the case may be.
The practical
implementation of certain parts of the Directive, involving high-activity
sources situated on dredgers operating on the high seas, posed some
difficulties and the way to solve them seems to be a strong point gained in
implementing the Directive in the maritime field. Indeed the costs of taking a
used source out of service can vary according to the dredger's location. For
that reason it is more difficult to define what an adequate financial guarantee
is. After examining various options, the DRP finally accepted a multi-stage
system proposed by the companies concerned. First, the supplier guarantees, by
a certificate, to take back all retired sources, while the company operating
the dredger undertakes to cover the costs of transfer and recycling. Should the
company become insolvent, the association of maritime dredging companies
guarantees to take care of the radioactive sources and to cover the associated
costs. A financial guarantee certificate from the association must be submitted
with the application.
Another difficulty
concern the controls, surveillance and monitoring of radioactive sources used
on the territories of other Member States. The DRP's position is that sources
on board of Luxembourg-registered dredgers are to be monitored, regardless of
where the vessel may actually be operating. Permanent monitoring of these
sources is guaranteed by the Luxembourg Maritime Affairs Agency, which can
pinpoint the location of each dredger at any time. DRP monitoring ends when the
source is returned to the supplier or the dredger is registered under another
flag. In these cases the company concerned must apply to the DRP for
authorization for the source to be exported or transferred to another Member
State.
As a non-nuclear
country Luxembourg is not operating a radioactive waste management facility.
The small national interim storage facility (NSIF) only holds waste for which
no license holder exists. This mainly concerns radioactive lightening
conductors, radioactive smoke detectors, orphan sources, radium sources, small
amounts of uranium or thorium salts, etc. An inventory of the disused sources
stored either on the users’ premises or on the authority’s premises
(NSIF) is managed by the DRP. 
During the recent
years, the amount of waste and disused sources stored in Luxembourg has been
reduced. At the licensee’s side this is due to the fact that some
facilities have stopped using radioactive sources and returned all disused
sources to the suppliers.

4.17.2.10.               
Security measures

The periodic
inspections focus on the radiological protection of the workers and the physical
protection of the sources.

4.17.3.                         
Detection
4.17.3.1.                   
Detection of orphan sources

All major metal
recycling and industrial waste management facilities have installed detection
portals at the site entrance. The equipment used is commercially available and
specially designed for the detection of radioactivity in scrap. On the only
existing harbour in Luxembourg a commercially available crane monitoring system
is used for the unloading of scrap from ships. A systematic radiation
monitoring at the international airport or at significant nodal transit points
is not yet realized, but concrete plans exist for the future. Moreover, the DRP
has provided tailored information for site staff on how to recognize and to
deal with orphan sources. In general it can be said that the number of orphan
source detections in Luxembourg is decreasing.

4.17.3.2.                   
Campaign for orphan sources recovery

In the context of
campaigns organization, the DRP collects radioactive waste and ensures the safe
management of these products. This collection is billed to the firm concerned
using an established procedure, and in certain cases is free of charge.

4.17.3.3.                   
International cooperation and information
exchanges

In the context of
nuclear safety, the government of the Grand Duchy of Luxembourg and the
government of Belgium and of France concluded an agreement concerning the
information exchange in case of an incident or accident, which might have
radiological consequences. The DRP reports also to the IAEA Incident and
Trafficking Database.

4.17.4.                         
Preparedness and Response
4.17.4.1.                   
Emergency plans and procedures

As facilities are
fully responsible for the safety of their radioactive sources, they have to
take the necessary steps to cope with radiological emergencies. Depending on
the quantities of radioactive substances, they have to draw up internal
emergency response plans taking into account the most probable accidents.
Periodic review of the plans and training of the staff by organizing regular
exercises are part of the conditions set in the license. In case of an
emergency, the license holder is obliged to notify immediately the DRP, the
Rescue Services Agency (ASS) and the labour inspectorate (ITM), to evaluate the
possible radiological consequences for the populations at risk, to take the
necessary steps to avoid or to stop the release of radioactivity in the
environment and limiting by that the exposure of individuals and to respect the
legal provisions in case of emergency exposures.
The Government has
set up a national emergency response plan to alert and to protect the
population in case of a radiological emergency. The Minister of Health and the
Minister of Interior are responsible for the off-site emergency planning. The
plan is activated and regularly tested by the DRP and by the ASS, in national,
bilateral and international exercises. Emergency teams have been formed to
assist in the event of a nuclear disaster, and refresher courses are held
periodically. 
Bilateral
agreements on mutual assistance have been concluded with Germany, France and
Belgium. These general agreements also cover radiological and nuclear
emergencies. A bilateral agreement on mutual early information has been
concluded with France and Belgium.

4.17.4.2.                   
Training and information of persons potentially
confronted with an orphan source

Several drills,
exercises and focused seminars have been organized over the last years in
cooperation with specialized intervention teams from neighbouring countries. In
particular with regard to contamination of radiological contaminated persons, a
close cooperation has been set up with specialized intervention teams in
Belgium and in France. Moreover the DRP has provided tailored information for
site staff (metal recycling industry) on how to recognize and to deal with
orphan sources.

4.18.                               
Malta 
4.18.1.                         
Regulatory framework with respect to HASS
4.18.1.1.                   
Regulatory authority

The Nuclear Safety
and Radiation Protection Regulations which were published in January 2003 are
primarily concerned with ensuring compliance with the EU directives in
occupational exposure to ionizing radiation 96/29/EURATOM and 90/641/EURATOM. The
NSRP regulation also establishes the Radiation Protection Board (RPB) which
acts as the regulatory authority in the field of nuclear safety and radiation
protection. 
The Radiation
Protection Board is responsible for all the requirements of the Council
Directive 2003/122/Euratom of 22 December 2003 on the control of high-activity
sealed radioactive sources and orphan sources (HASS directive). In that frame,
responsibilities are also assigned to the Civil Protection Department, member
of the RPB, to deal with radiological emergencies due to orphan sources.

4.18.1.2.                   
Legislative framework

The HASS directive
was fully transposed into the national regulatory framework by the enactment on
the 13th January 2006 of the Legal Notice 13 (regulations on the control and
security of high-activity radioactive and orphan sources). 
In the Legal
Notice 13 (2006), the same definition is being used for defining HASS as the
one specified in the HASS Directive. However, the related radiological criteria
(activity levels) for several radionuclides are different. As the HASS
directive was implemented together with the requirements of the IEAE Code of
Conduct, the Maltese high-activity levels correspond to the Category 3 levels
of the IAEA categorisation. Once a source is defined as a HASS, the
requirements of the Legal Notice 13 apply during the whole lifecycle of the
source on the territory of Malta.
All other
radioactive sources (with activity levels lower than the “activity level
3”) are regulated by the provisions of the Legal Notice 44 of 2003 (NSRP
regulation), which was already in force before the transposition of the HASS
directive. The NSRP regulation also covers the sources whose activity had
fallen down below the high-activity levels when the HASS directive was
transposed. 
The radioactive
sources, including those defined as HASS, are released from the regulatory
requirements once they fall below the exemption levels defined in the Directive
96/29/Euratom.

4.18.2.                         
Prevention and Deterrence
4.18.2.1.                   
Authorization for practice with HASS

The RPB requires
the holder to obtain prior high activity source authorisation for any practice
involving a source, including taking possession of a source. Before issuing an
authorization for the use of HASS, the RPB ensures that all arrangements and
provisions of the article 3 of the HASS directive are met. All these
requirements to obtain prior authorisation are listed in the article 8 of the
Legal Notice 13.
An authorization
for the use of a HASS has never been refused in Malta.

4.18.2.2.                   
Records keeping and updating

For the purpose of
controlling radioactive sources, every holder has to keep up to date records of
the quantity and location of radioactive substances under his responsibility.
The records keeping is regulated by the article 10 of the Legal Notice 13, 2006
(control and security of high-activity radioactive and orphan sources
regulations). The holder’s records shall be available for inspection by
the Board.
The Board shall
keep records of authorised holders and of the sources they hold. These records
shall include the radionuclide involved, the activity at the time of
manufacture, or if this activity is not known, the activity at the time of the
first placing on the market or at the time the holder acquired the source, and
the type of source. The Board shall keep the records up to date, taking
transfers into account, among other factors.
The RPB receives
on time every year the standard record form of HASS because yearly inspections
are organised in January for the HASS holders. If not yet provided, the
mandatory supply of the record form is reminded during that inspection. 

4.18.2.3.                   
National inventory

All radioactive
sources (covered and non-covered by the HASS Directive) are recorded to
establish the national inventory using the IAEA RAIS and an Excel sheet but
without sub-inventory for HASS holders/sources. The register is not available
to police organizations but a permanent mechanism for exchange information and
cooperation is established by the RPB with the customs authorities in order to
ensure adequate control over the sources entering and leaving the country.
Malta has a
limited inventory of radioactive sources that fall under the scope of Council
Directive 2003/122/EURATOM. The verification is made for each HASS, randomly
and at least for all the HASS every 12 months during inspection to check the
match between the actual situation of the HASS and the information recorded by
the holder.

4.18.2.4.                   
Inspections and penalties 

The inspections of
HASS holder are carried out once a year for the verification of compliance with
regulatory requirements of the Legal Notice 13. The inspections are related to
the fields of safety and security and are performed periodically (announced),
randomly (unannounced) or as a follow-up action in case of incident. 
Their scope
concerns the documentation, the inventory, a visual inspection of HASS and
their environment and the security measures. The match between the actual
situation and the information recorded by the holder is also controlled.
The inspectors are
not specifically trained but have a practical experience in nuclear metrology.
They have standard equipment but it is generally not used during inspection of
HASS holders. External dose rate equipment is measured when required and, if
required, surface contamination can be detected (via wipe tests). All equipment
is annually calibrated overseas.
Since the RPB is a
governmental body, the inspections are funded by the State.
In case of
breaches of regulations adopted pursuant to the HASS Directive, a system of
penalties is in place but has never been applied up to now. Penalties are
foreseen going up to 5 years imprisonment/ fine of 116 000 €.

4.18.2.5.                   
Control of HASS by the holder

The requirements
for holder are specified in the article 11 of the Legal Notice 13. In practice,
except visual verification, no particular request is addressed to the holder
for controlling the good conditions of its HASS. The regular performance of the
tests is not verified during the annual inspections. 

4.18.2.6.                   
Sources holders’ training

Before issuing
high activity source authorisation, the RPB ensures that the potential holder
of the source has provided minimum staff competencies, including information
and training. The training and information is covered by the article 13 of the
Legal Notice 13.
The training of
the HASS holder’s staff is defined and organized by the holder himself
for its exposed staff. The frequency of the training is not specified in the
regulation. After the training session, no comprehension test is organized and
no verification of the efficiency is performed by the authority. The training
sessions are however recorded because the trainee generally receives a
certificate of attendance from the training organisation.

4.18.2.7.                   
Identification and marking of HASS

The requirements
for identification and marking are defined in the article 12 of the Legal
Notice 13. The manufacturer shall identify or, in the case of sources imported
from outside the European Community, the supplier shall ensure that each source
is identified by a unique number. The manufacturer shall 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
indicating that the source is identified and marked. The information shall
include photographs of the source, source container, transport packaging,
device and equipment as appropriate.
The inspectors
check on arrival the documentation accompanying the HASS which systematically
includes the source identification. Once a year, the inspector performs a
physical check of the source container. 

4.18.2.8.                   
Transfers of HASS

The regulation
states that the holders shall notify and get approval in writing from the RPB
prior to any transfer of any source. Actually both the holder and the consignee
must notify the regulatory body and be authorised by the RPB before the
transfer is carried out. 
In case of
international transfer, the RPB shall ensure that the foreign recipient
effectively exists either by direct contact with the national competent
authority or by other means. Moreover, in case of transfer between Malta and
another Member State, the standard documents set in the 1493 Euratom Directive
will be exchanged to obtain the prior written declaration by the consignee that
he compiles, in the Member State of destination, with all applicable EU
provisions.
The RPB keeps the
records up to date, taking transfers into account, among other factor. The
Regulatory authority does not grant authorization for importation or
exportation or transit through the Maltese territory of nuclear material unless
it receives assurance that such material will be protected at the levels of
Physical Protection to be applied in International Transport of Nuclear
Materials as categorized in Annex II – Schedule 6 of the NSRP
regulations.
No cases where
HASS got out of control during transfer are known to the RPB.

4.18.2.9.                   
Long-term management of disused HASS

With respect to
the long term management, the national regulatory framework does not define a
limited useful life for HASS. Nevertheless, an authorization for using HASS is
issued only if the long term management route is specified and planned in the
request for authorization.
Adequate
management of disused sources, including agreements regarding the transfer, if
appropriate, of disused sources without undue delay after termination of the
use to a supplier, another authorised holder or a recognised installation must
be ensured before issuing the authorisation. The actual implemented strategy is
therefore return to supplier or transfer to another authorised holder outside
Malta. The authorisation is not issued to the HASS holder if such provisions
are not foreseen: import of a new source is now conditioned on its re-export.
The same rule also applies for non HASS: the authorization is granted only if
the source is sent out of Malta once disused. To summarise, the long-term
management of HASS and other sealed sources is today ensured through take-back
provisions incorporated in the supply contracts. 
A centralized
storage facility still does not exist in Malta. The solution implemented is the
storage at the holder’s premises awaiting the establishment of the
centralised storage facility. 

4.18.2.10.               
Security measures

The minimum
compulsory security requirements for HASS are locked premises and security
staff during use and storage at the holder’s premises. 
However, the RPB
requires for issuing high activity source authorisation to be provided with
measures to determine, as appropriate, the trustworthiness of individuals
involved in the management of radioactive sources and the confidentiality of
information relating to the security of sources and a security plan or
assessment including measures to detect and delay the unauthorised access to,
or the theft, loss or unauthorised use or removal of radioactive sources during
all stages of management. The security plan or assessment shall be periodically
reviewed and records of such reviews kept.
Moreover the
holder must ensure that each fixed and mobile source is subject to adequate
documented measures, aimed at preventing unauthorised access to or loss or
theft of the source or its damage by fire and must promptly notify the Board of
any loss, theft or unauthorised use of a source, arrange for a check on the
integrity of each source after any event, and inform the Board thereof and of
the measures taken

4.18.3.                         
Detection
4.18.3.1.                   
Detection of orphan sources

A general threat
assessment for any radiological incident has been performed at national level
by the authority but not specifically for HASS. The strategic locations
identified to detect orphan sources are borders/customs, transit hubs and
airports. These entities have been encouraged by the PRB to use detection
equipment on a voluntary basis. Indeed, the RPB shall encourage the
establishment of systems aimed at detecting orphan sources in places such as
large metal scrap yards and major metal scrap recycling installations where
orphan sources may generally be encountered, or at significant nodal transit
points, wherever appropriate, such as customs posts.
The
borders/customs, transit hubs and harbours are today equipped with both portal
monitors and portable radiation detectors whilst airports are monitored only
with portals. The Freeport of Malta where large number of containers arrives is
equipped with a set of 7 portal monitors. There are procedures for that portal
monitor system in place which involve Customs, RPB and the Port Operator. 
The metal scrap
yards are not equipped with detection means although the article 14.3 of the
Legal Notice 13 mentions that scrap metal dealers shall have access to an
appropriate radiation monitor in order to ascertain that no orphan sources are
present within the scrap metal. There is no metal melting facility in Malta.
The conventional waste management facilities or waste dump are not equipped
with portal monitor.

4.18.3.2.                   
Campaign for orphan sources recovery

Even if article
14.5 of the Legal Notice 13 specifies that the RPB shall organise, as
appropriate, the recovery of orphan sources left behind from past activities,
no recovery campaigns have taken place in Malta mainly because a centralised
storage facility is not available. Other reasons are the lack of budget and of
staff. In Malta, there is no financial strategy covering intervention costs
related to the recovery of orphan sources. According to the RPB, the best
method to recover orphan sources is the targeting of specific holders and
former holders.

4.18.3.3.                   
International cooperation and information
exchanges

As member of the
IAEA Incident and Trafficking Database (ITDB), Malta receives international
information and notifications.

4.18.4.                         
Preparedness and Response
4.18.4.1.                   
Emergency plans and procedures

Malta has a
national general radiological emergency plan based on a threat assessment,
including possible incident with HASS and orphan sources. Operating procedures
are established by the RPB.
The Civil
Protection Department shall be responsible for preparing for and managing
radiological emergencies which may occur in connection with practices or work
activities on or outside Maltese territory and which may affect Malta. The
response and management responsibilities of the Civil Protection Department
shall not be limited to off-site emergencies but shall extend to any on-site
emergencies which in the opinion of the Civil Protection Department, cannot be
managed by the radiation user. The Civil Protection Department is the agency
responsible to recover orphan sources and to deal with radiological emergencies
due to orphan sources and the department shall draw up appropriate response
plans and measures.
A compulsory
emergency preparedness and response plan has also to be developed by the HASS
holder. This one does need to be approved by the authority. The institutions
where orphan sources are more likely to be found are not submitted to this
obligation. 
In case of
emergency with an orphan source or HASS, the emergency services of the civil
protection department are available to intervene 24/7 with adequate
radiological intervention equipment (communication and measurement devices,
individual protection equipment, shielded containers and decontamination
material). The Civil Protection Department makes suitable provision for the
appropriate training of personnel who may be involved in technical, medical and
health intervention.
Up to now, the
emergency plan has never been initiated because of incidents with HASS or
orphan source detection.

4.18.4.2.                   
Training and information of persons potentially
confronted with an orphan source

The Legal Notice
13 of 2006 declares that the RPB will give specialised technical advice and
assistance to persons, not normally involved in operations subject to radiation
protection requirements, who suspect the presence of an orphan source. The
primary aim of advice and assistance shall be the protection of workers and
members of the public from radiation and the safety of the source.
A limited training
which is not requested by the regulations is organized for people who could be
confronted to orphan source. The training is addressed to emergency services
(police, fire fighters, and medical staff), customs office, transit hub, harbour
and airport personnel. The courses, never repeated, are documented but no
comprehension tests are organized. The training session includes practical
exercises with portal and hand-held instruments and a list of pictures of
typical sources and containers is presented.

4.19.                               
The Netherlands 
4.19.1.                         
Regulatory framework with respect to HASS
4.19.1.1.                   
Regulatory authority

The Nuclear
Installations and Safety Department of the Ministry of Economic Affairs is
competent in all topics of the HASS directive except the record keeping and the
inspections. The Radiation Protection Team of the Netherlands Enterprise Agency
(a division of the Ministry of Economic Affairs) issues the authorisation,
checks the availability of financial security for the long term management of
the source, and maintains the records of the sources and the HASS holders.
The Human
Environment and Transport Inspectorate, which is part of the Ministry of
Infrastructure and Environment but working under the responsibility of the
Ministry of Economic Affairs, is competent in the frame of inspections, orphan
sources management, international cooperation and penalties. Both the Human
Environment and Transport Inspectorate and the Labour Inspectorate monitor
compliance with the requirements regarding HASS. The Labour Inspectorate’s
inspections focus on measures for the protection of workers, while the Human
Environment and Transport Inspectorate focuses, in particular, on environmental
protection, compliance with the additional requirements, such as financial security,
and immediate transfer if the source is permanently withdrawn from use. The
Human Environment and Transport Inspectorate is also in charge when orphan
sources are found.
The responsibility
for nuclear activities is thus not centralised, but is shared by several
Ministers who consult each other and issue regulations jointly. There are some
recent developments on this subject. The Dutch Council of Ministers decided on
January 24, 2014 that the expertise in the area of nuclear safety and most of
the expertise on radiation protection will be brought together in a single
independent organisation in the Netherlands. The Authority for Nuclear Safety
and Radiation Protection (Autoriteit Nucleaire Veiligheid en
Stralingsbescherming, or ANVS) will be responsible for regulating the sector.
The new organisation will optimally utilise of the expertise and experience
available. As an Independent Administrative Authority (in Dutch a ZBO), the
ANVS will fall under the responsibility of the Minister of Infrastructure and
the Environment. Through the establishment of the ANVS, 150 staff members will
be part of a single independent organisation that meets international
standards, including those imposed by the International Atomic Energy Agency.
The new authority will draft legislation, develop safety requirements, issue
permits, carry out inspections, enforcement and provide information to the
public. The ANVS will also be jointly responsible (with the local authorities
and the ministry of Safety and Justice) for emergency preparedness in the event
of incidents which could result in the release of radiation.

4.19.1.2.                   
Legislative framework

In the
Netherlands, the basic legislation concerning nuclear activities is set out in
the 1963 Nuclear Energy Act ('Kernenergiewet’; Bulletin of Acts and
Decrees, 1963, No. 82), as last amended in 2014.
The requirements
of Directive 2003/122/Euratom have been implemented in Dutch regulatory regime
by both the Radiation Protection Decree ('Besluit stralingsbescherming'
Bulletin of Acts and Decrees No 260, 2006) and the Ministerial Order on HASS
(‘Regeling hoogactieve bronnen’, Government Gazette No 114,  2006)
which provides the HASS holders with technical instructions. Both regulations
were last amended on January 1, 2014, the requirements from the Ministerial
Order on HASS were transposed to the Regulation Implementing the Radiation
Protection Decree (‘Uitvoeringsregeling Stralingsbescherming EZ’;
Government Gazette 32478, 2013).
Until January 1,
2014, the regulation used the same definition for a high-active source as the
one from the HASS Directive. A HASS stayed covered by this regulation until
decay below the national clearance levels. Sources that would have been
considered as HASS but whose activity had fallen down below the high-activity
levels before the transposition of the Directive were covered by provisions for
non-HASS. On January 1, 2014 the definition of HASS was amended (Radiation
Protection Decree), "high-activity sealed source" means a sealed
source for which the activity of the contained radionuclide is equal to or
exceeds the relevant activity value, thus anticipating the definition of HASS
as stipulated in the 2013/59/EURATOM directive (but with the activity levels
from the 2003/122/EURATOM directive).
Most of the
requirements of the Directive were already applicable in the Netherlands
because, when Directive 96/29/Euratom was implemented, the situation at the
time was enforced by strict national rules on a number of points. The
requirements of the HASS Directive with respect to orphan sources were already
provided for in the 2002 Decree on the detection of radioactive contaminated
scrap (‘Besluit detective radioactief besmet schroot’; Bulletin of
Acts and Decrees No. 661, 2002, as last amended in 2011) and the 2003 Order on
the detection of radioactive contaminated scrap (‘Regeling detective radioactief
besmet schroot’; Government Gazette No. 81, 2003, as last amended in
2009). Main differences between regulations before and after the HASS Directive
transposition are found in the record keeping, the requirements for the
holders, the identification and marking of the sources, the training of
personnel, the financial security for orphan sources and the report on
experience.

4.19.2.                         
Prevention and Deterrence
4.19.2.1.                   
Authorization for practice with HASS

For any activities
involving a high-activity source, an operator must be authorised under the
Nuclear Energy Act. The Radiation Protection Team of the Netherlands Enterprise
Agency is otified as the competent authority for issuing, assessing and
implementing the authorisation. Before issuing an authorisation for the use of
a HASS, the authorities ensure that most of the arrangement and provisions of
Article 3 “Authorisation” of the HASS directive are met.
Furthermore, the operator must draw up written instructions aimed at preventing
unauthorised access to a HASS, its loss or theft, or damage by fire. Before the
acquisition of a new HASS, the holder must provide a financial security for the
costs associated with safe disposal of the HASS. Within two weeks after acquiring
the source, the operator must also notify the Netherlands Enterprise Agency by
submitting the relevant data using the standard form available. 
The license
stipulates that within a maximum of 2 years after termination of use, the
holder must get rid of the disused HASS. Once the HASS is removed, the holder
must notify the authority within 2 weeks. 
An authorisation
has never been refused for use of a HASS in the Netherlands.

4.19.2.2.                   
Records keeping and updating

HASS holders must
keep records of the ionising radiation sources held by them and provide the
recorded information to the Netherlands Enterprise Agency with the standard
form available within two weeks after acquisition, annually and within two
weeks when the holder no longer holds the source. Random checks are made during
inspections. According to inspection’s results, companies occasionally
fail to submit the compulsory ‘annual’ declaration giving an
overview of all HASS held. The information is considered as complete but the
tolerated delay of two weeks is generally exceeded. In 2014 the annual
declaration to the Netherlands Enterprise Agency has been complete (68
licensees with HASS sources).

4.19.2.3.                   
National inventory

The national
inventory is established from the information provided during the authorisation
request and the annual declaration. A centralised inventory of all HASS within
the Dutch territory will be established. This national inventory will depict
the situation on January 1, 2014 and will be broadened in the future. 
This inventory is
available for inspection by competent Authorities, and would be communicated on
request to Police and customs organization. The Authority checks the match of
recorded information and actual situation during inspections.

4.19.2.4.                   
Inspections and penalties 

Both the Inspectorate
of the Ministry of Social Affairs and Employment and the Human Environment and
Transport Inspectorate perform inspections on radiological aspects using a
systematic approach (risk based). In addition complementary unannounced
inspections of HASS holders are organised two to three times per year.
Inspections are also organized as follow-up action in case of incident or any
other suspicious situation. Inspections are funded by the State.
Their scope covers
safety aspects such as documentation, labelling, inventory, financial security,
visual inspection of the HASS and their environment, contamination and dose
rate measurements and security aspects. The inspectors verify the regular
performance of suitable leak tests by the holder by asking the corresponding
registration document.
The training of
the inspectors contains practical experience in nuclear metrology, information
concerning their potential confrontation with a source, the visual detection of
sources and containers and the specific requirements for their safe management,
possible consequences of loss, theft or inadequate use of sources and
procedures/responses to be followed in case of emergency situation. 
Penalties are
foreseen in case of breach of the national provisions pursuant to the HASS Directive.
Penalties depend on the kind of breaches and the seriousness of damage caused
by them. This is determined by the public prosecutor’s office.

4.19.2.5.                   
Control of HASS by the holder

Visual
verification, leak tests and dose rate measurements must be carried out by the
holder once a year and also systematically in case of possible damage of the
source. Leak tests must be understood as a contamination check of the device. 

4.19.2.6.                   
Sources holders’ training

HASS are used by
or under the responsibility of a radiation expert. HASS holder must prepare and
organise the prescribed training of the radiation protection officer and the
exposed workers once every two years. The scope of this training covers
radiation protection principles, specific requirements for safe management of
sources, possible consequences of loss, theft or inadequate use of sources,
prompt notification to the competent authorities and emergency responses in
case of an accident. Training sessions are recorded but there is no
comprehension test organised. The competent authority checks the training
records during inspection.
According to
inspection’s results, the level of compliance with the requirements for
training is not respected in all industries. Holders must draw up the
instructions themselves and conduct training that is specifically targeted to
the company’s own situation. In some industries, the expertise needed to
do this is often insufficient. 

4.19.2.7.                   
Identification and marking of HASS

The documentation
accompanying the HASS is generally complete including the source identification
(on the source and on the container) and all relevant information and
photographs concerning the source design, the source container, and the
associated device or equipment. Transport packaging is less described. 
In order to prevent
the occurrence of high-activity orphan sources (including those of Dutch
origin), a unique identification code on the source or the source holder has
been required since the HASS Directive entered into force. The Netherlands
Enterprise Agency has given ID-codes to ten licensees; one manufacturer, one
supplier and eight holders of old sources (that didn’t have a unique
identification code). The correct identification marking of HASS is controlled
during inspection. 

4.19.2.8.                   
Transfers of HASS

For national
transfer of HASS, Netherlands Enterprise Agency must be notified by both the
holder and the recipient. Moreover transfers are confirmed by the records of
the holders. In case of transfer between The Netherlands and another Member
State, the standard documents set in the 1493 Euratom Directive are also
exchanged. In case of international transfer, Netherlands Enterprise Agency
will be notified by the Dutch supplier or holder but will not request the prior
consent of the authority of the importing State.
There is no case
of source lost or out of control due to unrecorded transfer.

4.19.2.9.                   
Long-term management of disused HASS 

There is no
recommended working life for HASS in the national regulatory framework. The
long term management of the source is prepaid by the holder. Before receiving
its license, the HASS holder must provide a financial security for the costs
associated with safe disposal of the HASS. The financial security is required
to each HASS holder even if the take-back of the disused HASS is contractually
ensured by the supplier. All licensed holders that use HASS have provided a
financial security in the form of a bank guarantee, insurance agreement or
deposit.
In the past
several cases of holders which did not provide financial security at the
acquisition time have been encountered. These holders had to pay for the long
term management of the source after the use.
The options for
long-term management of the disused sources are return to supplier, re-use by
another authorized holder and finally transfer to the waste management
facility. 
The authorisation
of disused HASS storage at the user’s premise is limited. Indeed,
adequate arrangements should be made by the holder as soon as possible with a
maximum of two years after termination of the use of the HASS. According to the
Dutch regulation the take-back of the disused HASS by the supplier is
mandatory. However, the existence of contractual take-back provisions is not
formally verified by the authority. 
The Central
Organisation for Radioactive Waste (COVRA: Centrale Organisatie Voor
Radioactief Afval) was created by the Netherlands Government in 1982 to assume
responsibility for all aspects of the management of radioactive waste in the
Netherlands, including collection and transport, treatment and conditioning, temporary
and/or permanent storage and disposal, including the necessary research
activities in line with government policy. This facility is authorised and has
the capacity to accept disused HASS. 

4.19.2.10.               
Security measures

In the
Netherlands, the highest risk of loss of control exists with regard to the
mobile use of HASS. Security requirements for HASS storage are general: the
operator must draw up written instructions aimed at preventing unauthorised
access to a high-activity source, its loss or theft, or damage of the source by
fire. Locked premises are required for storage places; mobile sources must be
equipped with a lock at the place of their use. New specific regulation on the
security of radioactive material was enacted in the Regulation on the security
of radioactive materials on April 1, 2013 ’Regeling beveiliging
radioactieve stoffen’; Government Gazette 25427, 2012, and were
transposed to the Regulation Implementing the Radiation Protection Decree on
January 1, 2014 (‘Uitvoeringsregeling Stralingsbescherming EZ’;
Government Gazette 32478, 2013).
Requirements
include the measures to be taken by a licensee to reach a prescribed delay time
after an attempt of theft of the source, to allow enough time for response.
These measures can be organisational (e.g. screening of staff), constructional
(e.g. locks and fences) and electronic (e.g. detection systems). The measures
taken must be drawn up into the security plan, which has to be re-evaluated
periodically.

4.19.3.                         
Detection
4.19.3.1.                   
Detection of orphan sources

A threat assessment
concerning the orphan sources has been performed by the authority at the
national level. It includes strategic locations for finding orphan sources such
as metal scrap yards, metal scrap recycling facilities, metallurgical
industries but not the conventional waste management facilities. As required by
the Decree on the detection of radioactive contaminated scrap (‘Besluit
detectie radioactief besmet schroot’, as mentioned in section 1.19.1.2)
and the Order on the detection of radioactive contaminated scrap
(‘Regeling detectie radioactief besmet schroot’, also mentioned in
section 1.19.1.2), the larger metal scrap yard sites are subjected to legal
obligations to install their own detection gates and the use of detectors on
grabs for bulk loads to avoid the entrance of contaminated scrap or orphan
sources in the production chain. They are bound to handle their alarm
detections with the Human Environment and Transport Inspectorate directly. 
The customs
authorities also carry out large scale screening of containers for the presence
of radioactive materials. 
With respect to
goods submitted to the licensing requirements for import and export and related
transport a risk oriented approach is used to define the goods that are
effectively verified by the customs. This control is essentially based on
document verification with respect to the licensing obligations. Furthermore
the customs organization has realized completely integrated and centralized
networks of radiation detection gates covering all ways of access/exit by road
and rail to the port premises. Mobile detection systems on a car can be used to
monitor internal transfers and access/exit by inland navigation as the latter
terminals are only partially equipped with radiation detection gates. 
Non acceptable and
suspected loads are further handled under decision and surveillance of an
inspector of the Human Environment and Transport Inspectorate on a case by case
base, including for unloading of containers and isolation of radioactive
objects, temporary storage at the terminal, transfer to COVRA and/or return to
the country of origin.

4.19.3.2.                   
Campaign for orphan sources recovery

There is no
structural recovery campaign organized in the Netherlands. Orphan sources are
detected fairly regularly by the detection systems installed at the scrap yards
and at the national borders. Over the years, a limited number of high-activity
orphan sources have been found, always in scrap of foreign origin. The recovery
operations are normally paid by the scrap yard facility where the orphan source
is found. The facility can afterwards turn against the importing scrap company.
In addition each major metal company has set a financial security to ensure the
funding of the costs of the source recovery and disposal in case the scrap
facility is not capable of covering them (due to bankruptcy).
No high-activity
orphan sources of Dutch origin have ever been found either in the Netherlands
or, as far as known, abroad.

4.19.3.3.                   
International cooperation and information
exchanges

The Netherlands
participates in international cooperation and exchange of information, mainly
through the established IAEA-channels. The county contributes through
notifications to the IAEA Incident and Trafficking Data Base (IDTB), the IAEA
International Nuclear Events Scale (INES) and the ECURIE-system. 

4.19.4.                         
Preparedness and Response
4.19.4.1.                   
Emergency plans and procedures

HASS holders and
facility operators of institutions where orphan sources are more likely to be
found must prepare an emergency response plan. These plans are neither to be approved
nor to be reviewed by the Authority.
A national
response plan in relation with orphan sources is in place. A team is available
24/7, equipped with dedicated vehicles, communication devices, measurement
devices, shielded containers, individual protection equipment and
decontamination material. In case of detection of orphan sources, a single
point of contact is accessible by dedicated emergency call number broadcasted
to emergency services and institutions likely to be confronted with orphan
sources.

4.19.4.2.                   
Training and information of persons potentially
confronted with an orphan source

Training of
workers responsible for detection of radioactive material is mandatory for
metal companies. The training addresses the complete information needed to
detect and safely act in case of source detection. It includes practical
exercises with portal detectors and hand-held instruments. The training is
documented but there is no comprehensive test organised and it is not regularly
repeated.
HASS holders must
prepare and organise the prescribed training of the radiation protection
officer and the exposed workers once every two years. The scope covers
radiation protection principles, specific requirements for safe management of
sources, possible consequences of loss, theft or inadequate use of sources,
prompt notification to the competent authorities and emergency responses in
case of an accident. Training sessions are recorded but there is no
comprehension test organised. The competent authority checks the training records
during inspection.
Training is not
explicitly required for emergency services.

4.20.                               
Poland 
4.20.1.                         
Regulatory framework with respect to HASS
4.20.1.1.                   
Regulatory authority

The competent
Authority in accordance with the HASS Directive is the National Atomic Energy
Agency.

4.20.1.2.                   
Legislative framework

The HASS Directive
has been fully transposed in the national legislation by means of the Act of
Parliament of 11 April 2008 amending the Act of Parliament of 29 November 2000,
the Atomic Law. The Articles 5, 43 (4), 43a-c, 47, 77 of the Atomic Law contain
the provisions for radiation safety. Furthermore, §19 of the Regulation of the
Council of Ministers of 12 July 2006 include the detailed safety requirements
for work involving ionising radiation sources.
The alternative
HASS definition in the Polish legal framework is the following: "high-activity
source – sealed radioactive source containing a radioactive isotope whose
activity at the moment of source manufacture or, if that value is unknown, at
the moment when the source is introduced for sale, is equal to, or higher than,
the threshold activity for a high activity source, as specified in Annex No. 2
to the Act, however the source ceases to be a “high-activity
source” if its activity decreases below this threshold level."
The regulation in
force for the sources with activity levels below those defined in the
regulatory framework for HASS is the same law and the above-mentioned
regulation of 12 July 2006. There are minor differences between this regulation
and the requirements of the transposed HASS Directive concerning the
authorisation, transfers, records and identification and marking.

4.20.2.                         
Prevention and Deterrence
4.20.2.1.                   
Authorization for practice with HASS

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; 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 working life
of HASS is not considered as a requirement when giving the authorisation.

4.20.2.2.                   
Records keeping and updating

The HASS holder
keeps records for HASS under his responsibility, which is sent to the competent
authority, respecting a maximal time delay of 7 working days. The records have
to be sent yearly and when the holder no longer uses the source. The
information recorded by the HASS Holder is sent in written copy. This written
copy is required as evidence that has to be kept. In Poland there does not seem
to be a practical value for sending this data also in electronic form. This
would require appropriate data protection measures.

4.20.2.3.                   
National inventory

The recorded
information received through the standard record sheet is used to establish a
national inventory of the HASS and the authorised HASS holders. The data is
processed in an electronic database. The data on the sources not covered by the
HASS Directive are also kept in this register. Not all the information from the
standard record sheet (in Annex II of the Directive) is transferred to the
electronic database. The information that is not recorded concerns the type of
equipment/container, the manufacturer details, if the source is mobile or
fixed. Increasing the scope of data stored in the electronic database is
considered unnecessary.
Data in the
national inventory are available to police organisations and to customs after
official request. 

4.20.2.4.                   
Inspections and penalties 

During inspections
directly funded by the State, the Authority checks the match between the actual
situation of the HASS and the information recorded by the holder. The National
Atomic Energy Agency is in charge of the inspection of HASS holders for Safety
(Sf), Security (Sc) and Non Proliferation (NP). The planning is organised
periodically (announced) and randomly (unannounced) for the three fields. The frequency
of periodic inspections of authorised holders in the medical sector is yearly,
in other sectors 2 yearly.
The inspectors are
trained in the following fields: practical experience on nuclear metrology;
information concerning potential 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.
Penalties to
infringement are described in the Art. 123 of the Atomic Law. An administrative
penalty is imposed in an amount not exceeding the fivefold average monthly pay
in the national economy in the calendar year prior to the commitment of the
offence. The penalties have already been applied.

4.20.2.5.                   
Control of HASS by the holder

HASS are tested by
the holders every 2 years. These tests are limited to a visual inspection and a
verification of the dose rate. Leak tests are not performed. During the
inspections, the Regulatory authority verifies the performance of these tests.

4.20.2.6.                   
Sources holders’ training

The definition of
the training program of the HASS holders’ staff is done by the holder and
the training material is prepared by an organisation recognised by the
Authority. According to the legislation, the head of the organisation shall be
obliged to ensure, at least every 5 years, the preliminary and periodic
training of workers on nuclear safety and radiological protection issues,
according to the defined training program. Appropriate training shall be also
given to workers participating in the transport of nuclear materials,
radioactive sources, radioactive waste and spent nuclear fuel. All categories
of workers are subjected to training. The training sessions are recorded and
comprehension tests are organised. The performance and efficiency of the
training sessions is carried out by checking training records during
inspections

4.20.2.7.                   
Identification and marking of HASS

Verification of
the correct marking of the source is performed by the producer (one in Poland).
Documentation accompanying the HASS includes the source identification,
information and photographs of the source design type and information and
photographs of the typical source container. Information on the transport
package and photographs of the device and equipment are generally not present.

4.20.2.8.                   
Transfers of HASS

The Authority is
informed of individual transfers by issuing an authorisation/permit to the
holder for the transfer and to the recipient in case of a national transfer.
The holder ascertains that the Recipient holds an appropriate authorisation by
asking a copy of it.
Third country
recipient should fill out the declaration required by the Regulation on the
terms for import into, export from and transit through the territory of the
Republic of Poland, of nuclear materials, radioactive sources and equipment
containing such sources, and send it to the Holder after obtaining confirmation
from competent authority of the country of destination. According to the
Council Regulation No.1493/93/EURATOM, the standard declaration form is
required within the EU.

4.20.2.9.                   
Long-term management of disused HASS 

The national
regulatory system does not define a limited useful life for HASS. The preferred
strategy for the long-term management is the transfer for re-use to another
authorised holder and in second place, return to the supplier. Transfer to
storage facility would be the third option.
The solutions
actually implemented are the return to the supplier, then the transfer for
re-use, and finally the transfer to storage facility. There is a national
authorised storage facility for radioactive waste that accepts disused HASS.
Its capacity is adapted to the potential amount of disused sources.
After termination
of its use, the holder is not authorised to store the disused HASS at its
premises. The holder is forced to make adequate arrangements for the long-term
management of the HASS due to the fact that the authorisation is issued only if
the long-term management route is already specified and planned.
The long-term
management of disused HASS is funded by take-back provisions incorporated in
the supply contract and by funds set by the holder of the source and managed by
the Radioactive Waste Management Plant - State owned company (RWMP-SC).

4.20.2.10.               
Security measures

Adequate security
measures are implemented in all sites where HASS are used and/or stored.

4.20.3.                         
Detection
4.20.3.1.                   
Detection of orphan sources

The Authority has
performed a threat assessment concerning the orphan sources. All locations
considered strategic were considered with the exception of transit hubs. The
controls on radioactivity in all these strategic locations are compulsory. The
detection equipment consists of portals and portable systems.

4.20.3.2.                   
Campaign for orphan sources recovery

The regulatory
framework does not ensure that searching campaigns to recover orphan sources
are organised. No systematic recovery campaigns have been organised in the
country. However, a systematic training was conducted at the scrap recovery
points with regard to the identification of orphan radioactive sources. Those
responsible for the management of such businesses recognise that this is for
the benefit of their workers and cooperate fully. There is also appropriate
equipment available to identify radioactive material and sources.
There is a
financial strategy covering intervention costs supported by the State. The best
method to recover the greatest number of orphan sources is using or installing
radiation detection equipment in strategic locations.

4.20.3.3.                   
International cooperation and information
exchanges

Poland contributes
to the IAEA Incident and Trafficking Database since 1996.

4.20.4.                         
Preparedness and Response
4.20.4.1.                   
Emergency plans and procedures

Poland has a
national radiological emergency response plan in place with relation to HASS
and orphan sources. The national emergency plan is activated when the impact of
radiation emergency event extends, or may extend, over a large territory. Each
province has got its own crisis management centre (operated 24/7) collecting
information about any emergency situation, including radiation emergency
events. In the case of an orphan source discovery in a public place, the
regional emergency plan is activated. If needed, the regional services can be
supported by the survey team of the National Atomic Energy Agency (PAA),
available 24/7 with all necessary devices.
There are
compulsory emergency preparedness and response requirements for HASS holders
and for the operators of facilities and institutions where orphan sources are
more likely to be found. The Border Guard and Customs Service are obliged to
develop and maintain a response procedure in case of discovery of illicit
trafficking.
There is a unique
contact point in case of discovery of an orphan source: the National Warning
Point placed in the Radiation Emergency Centre. 

4.20.4.2.                   
Training and information of persons potentially
confronted with an orphan source

The head of an
entity, whose workers may come into contact with orphan sources during their
work, in particular the head of an organisation that stores, sells or processes
scrap metal, shall provide such workers with the training that includes
information on the possibility of contact with such source, visual detection of
orphan sources and their containers, basic information on ionising radiation
and its consequences, and information on actions which should be undertaken in
the event of detection or suspected presence of an orphan source.
The training is addressed to workers and
customs managers are trained as well. Training is provided in accordance with
the emergency preparedness plan to be submitted as part of the application for
the license given to the source holder. This plan is required to predict
potential accident scenarios that are then covered in the training, including
practical drills. The courses are documented, regularly repeated at a frequency
of 1-5 years. There are comprehension tests organised and the training sessions
include practical exercises.

4.21.                               
Portugal 
4.21.1.                         
Regulatory framework with respect to HASS
4.21.1.1.                   
Regulatory authority

Portugal has a
complex regulatory framework characterized by the existence of various entities
with competences in the areas of radiation protection and nuclear safety being
allocated to several institutions under different Ministries. According to
Decree-Law 165/2002, the licensing authorities in the different areas of
health, energy production and mining, industry and research are generally part
of or assigned to the respective Ministries, as follows:
·        
The
Lisbon Tech (Instituto Superior Técnico, IST), of the Ministry of Education and
Science, is responsible for authorizing all operations associated to the use of
sealed sources by issuing ownership, transfer, transport, selling and renting
licenses; 
·        
The
Directorate-General of Health (DGS), of the Ministry of Health, is responsible
for licensing all equipment and activities which produce ionising radiation,
excluding all activities related with nuclear fuel cycle;
·        
The
General-Directorate for Energy and Geology (DGEG) authorizes the transfer, transport
and return of fresh nuclear fuel;
·        
The
Regional Directorates of Economy (DRE) are responsible for licensing the
extraction and processing of radioactive ores.
Thus according to
Decree-Law 165/2002, Directorate-General of Health (DGS), of the Ministry of
Health is responsible for authorizing each practice (equipment and activities)
which produces ionising radiation, excluding all activities related with
nuclear fuel cycle. To implement Directive 2003/122/Euratom, the Instituto
Tecnológico e Nuclear, I.T.N., I.P. (Technological and Nuclear Institute) was
designated as the competent authority under Decree Law No 38/2007. 
However, recently,
pursuant to Article 1 of Decree Law No 29/2012 of 9 February 2012, the
Instituto Superior Técnico (IST) merged with the ITN, I.P., and therefore now
IST has the responsibility for ensuring the mission, functions and powers which
the Law conferred on the former Institute. Accordingly, IST of the Ministry of
Education and Science is responsible for authorizing all operations associated
to the use of sealed sources by issuing ownership, transfer, transport, selling
and renting licenses. 
The Decree-Law No
30/2012 of 9 February created the Regulatory authority for the Safety of
Nuclear Installations (COMRSIN) responsible for licensing nuclear fuel cycle
facilities.

4.21.1.2.                   
Legislative framework

There is no
nuclear power programme, neither source manufacturer in Portugal. The IST
(Instituto Superior Técnico) owns and operates, for research purpose, a
light-water research reactor (1 MWe).
The regulatory
framework governing the nuclear sector is complex including several laws,
regulations and decrees, frequently derogating each other.
The Council
Directive in occupational exposure to ionizing radiation 96/29/EURATOM (Basic
safety Standards) is transposed in the following:
·        
Decree-Law
165/2002: amended by Decree-Law 215/2008, setting out the competencies of the
bodies intervening in the field of protection against ionising radiation, as
well as general principles of such protection;
·        
Decree-Law
167/2002: amended by Decree-Law 215/2008, setting out the legal framework for
the licensing and functioning of entities protection against ionising
radiation, as well as general principles of such protection;
·        
Decree-Law
174/2002: set out the rules applicable to interventions in case of a
radiological emergency;
·        
Decree-Law
139/2005: creation of the CIPRSN Commission for Radiological Protection and
Nuclear Safety
·        
Decree-Law
140/2005: set out the exemption levels
·        
Decree-Law
222/2008: set out basic security rules concerning the sanitary protection of
the population and of workers against dangers arising from ionising radiation
·        
Decree-Law
227/2008 establishes the requirements for training in radiation protection
The Decree-Law
38/2007 of 19 February 2007 is setting out the legal framework for the control
of sealed radioactive sources, including orphan sources. It fully transposes
the HASS Directive and used the same definition for a high-active source as the
one from the HASS Directive. The Decree-Law is applicable for HASS, non-HASS
and for existing sources which would have been declared as HASS before the
transposition of the HASS Directive. A HASS falling below the defined
high-activity levels is still covered by this law until its activity falls
below exemption levels. No clearance levels are set.

4.21.2.                         
Prevention and Deterrence
4.21.2.1.                   
Authorization for practice with HASS

DGS authorizes the
use of sources in the context of a specific practice. IST authorizes ownership,
transfer, transport, selling and renting of the sources.
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, availability of documentation and procedures
for work and maintenance, emergency procedures and communication links,
adequate arrangements for long term management of disused sources, control
measures implemented to prevent inadequate use, unauthorized access, loss or
theft or fire flooding etc. are considered.
In addition, an
emergency plan is requested whenever the source exceeds 1 TBq and the design of
parts of the equipment is requested if the end-use of the source justifies
this.
Like Article 3(3)
of Directive 2003/122/Euratom, Article 4(9) of Decree Law No 38/2007 lays down
that the licence must include the following references:
a)    legal
responsibilities of the holder of the authorisation;
b)    minimum skills required of those responsible for the source,
including information and training;
c)    minimum
source, source container and additional equipment performance criteria;
d)    requirements
for emergency procedures and communication links;
e)    work
procedures to be followed;
f)     maintenance
of equipment, sources and containers;
g)                instructions on the proper handling of disused
sources, including agreements regarding the transfer, if appropriate, of
disused sources to a supplier, another authorized holder or a recognized
installation.
Regarding the
system of authorization of a HASS, the IST is the competent authority to issue
the licence for the use and the possession of a HASS. The DGS is the national
competent authority to grant a licence to all activities that involves ionizing
radiation. Therefore, all HASS holders shall own two different licences, which
are the following: i) the licence to develop activities which involves ionizing
radiation, ii) the authorization for the use and possession of a HASS. The
licence to develop activities which involves ionizing radiation is granted by
DGS in accordance with the Decree-Law 165/2002, which partially transposes the
Directive 96/29/Euratom.
The IST has
already refused an authorisation for use and possession of a HASS because the
holder had no license of activity issued by DGS.

4.21.2.2.                   
Records keeping and updating

In accordance with
the legislation, the HASS holder keeps records of the sources under its
responsibility and their location. He provides the recorded information to IST,
at the acquisition time, annually, when requested and when the holder no longer
holds the source. The Holder must record all the sources. These records are
subject to inspection by the competent authority. The tolerated delay to
provide the information is 30 days, 15 days after acquisition of the source.
The information is transferred electronically or through written copy. 

4.21.2.3.                   
National inventory

The information
for sealed sources is recorded in the national inventory which is processed by
electronic database since 2009. HASS and non HASS are gathered in the same
database, the recorded information are mainly holder’s details,
radiological characterization of the source (radionuclide, activity at the time
of manufacture or, if this activity is not known, the activity at the time of
the first placing on the market or at the time the holder acquired the source),
type of source and equipment (mobile or not), location of the source, the
manufacturer’s details are not recorded.
The
Directorate-General for Health must be informed on a quarterly basis of the
record made by the competent authority (IST). IST shall send to DGS a quarterly
report covering the record of HASS.
The national
inventory is not considered complete as some HASS were not recorded in the
past.This inventory is available to customs and police organizations.

4.21.2.4.                   
Inspections and penalties 

There is neither
periodic inspection nor unannounced inspection on HASS. Inspections for safety
and security aspects are realized by IST only as follow-up action in case of
incident or in any other suspicious situation. No information is available
about the training of the inspectors and their standard equipment, about the
scope of the inspections and how these inspections are funded.
Decree Law 38/2007
(Article 17) foresees penalties ranged from 250 to 44 890 € depending on
the importance of the breaches. 
These penalties
have never been applied.

4.21.2.5.                   
Control of HASS by the holder

As well as it is
established in the Annex II of the Directive 2003/122/Euratom  - Standard
Record Sheet for High Activity Sealed Sources (HASS) -, the Decree-Law nr.
38/2007 foresees in its Annex IV some data information to provide by the HASS
holder. The paragraph 6 of the Annex IV of the Portuguese Decree-Law corresponds
to the operational control HASS. The fulfilment of the paragraph 6 by the HASS
holders allows the competent authority to verify the regular performance of
suitable tests to control good conditions of the HASS.
Tests carried out
by the holder are only dose rate measurements. The competent authority is
informed on the control measures to prevent any incident involving the HASS
during the authorization process. No further control is organized.

4.21.2.6.                   
Sources holders’ training

The training
program of the HASS holder’s staff is defined by the DGS
(Directorate-General of Health). IST (recognized organization) is giving the
training sessions. Frequency is not set: training is given at request of the
HASS holders.
Training covers
all the relevant items and is given to all the categories of workers.
Participation to the training session is recorded and comprehension tests are
organized, the authority does not check the performance and the efficiency of
the training session.

4.21.2.7.                   
Identification and marking of HASS

There is no more
HASS manufacturer in Portugal. The documentation accompanying a HASS is
generally limited to the source identification on the source or on the
container. It is the duty of the source holder to have documented information
with photographs of the source, the source container, transport packaging, and
the device or equipment as appropriate.
The correct
identification and marking of the HASS is not currently verified. 

4.21.2.8.                   
Transfers of HASS

National competent
authority authorizes transfer of HASS by issuing licenses to the holder, to the
recipient (if national) and to the transport company. Before transferring a
HASS, the holder asks a copy of the recipient’s authorization.

4.21.2.9.                   
Long-term management of disused HASS 

There is no
recommended working life in the national regulatory framework. The holder is
forced to make adequate arrangements for long-term management after termination
of use by the following manner. The licensee must pay a deposit for each sealed
source. Once the licensee considers that the source is no longer used for the
practice for which the authorization has been granted, it should be either
returned to the manufacturer or collected by the IST. Article 10 (4) of the
Decree-Law No. 38/2007 establishes that the IST will then refund the deposit made
by the licensee after proof that the spent and/or disused source was returned
to the manufacturer or collected by the IST. Licensees also have to deliver the
annual declaration of the sources in use. However, this deposit does not cover
the cost of long term management of disused sealed source. Whenever the disused
sealed source is collected by IST, it is considered as radioactive waste. In
this case, the cost of the long term management is supported by the state
budget.
There is no
information about the maximum storage time at user’s premises after
termination of use. The options for long-term management of the disused sources
are, by order of preference, return to supplier, re-use by another authorized
holder and finally collection by IST for long-term management. In facts, re-use
is the least implemented option.
The national
interim storage facility (PAIRR) is also authorized for HASS interim storage
but its capacity is limited. It is only an interim storage and it is not
adapted for disposal of HASS. The Portuguese government must find a solution
for the long-term management of the sources.
There is no plan
for final disposal facility in Portugal.

4.21.2.10.               
Security measures

Security measures
at the holder’s premises during use of HASS are locked premises and fire
detection system. No measures are defined for other places.

4.21.3.                         
Detection
4.21.3.1.                   
Detection of orphan sources

A threat
assessment concerning the orphan sources has been performed by the authority at
national level. It includes strategic locations for finding orphan sources such
as metal scrap yards, metal scrap recycling facilities, metallurgical
industries, conventional waste management facilities, borders, harbours,
airports and transit hubs. All these strategic locations are currently equipped
with portable and/or portal detection means. However, as these kind of
equipment’s is subject to a voluntary basis, therefore some metal scrap
yards, metal scrap recycling facilities, conventional waste management
facilities, or borders are not equipped with portable and/or portal detection.
The equipment are not authorized by the authority.
There is no other
strategy implemented to detect orphan sources.

4.21.3.2.                   
Campaign for orphan sources recovery

There has been no
recovery campaign organized in Portugal. There is no dedicated budget for this.
Recovery campaigns are considered, with the use of detection equipment in the
strategic locations, like the best methods for orphan sources recovery. It is
the responsibility of the competent authority (IST) to organise annual
campaigns for the collection of orphan sources. However, it has been difficult
in practice to implement these campaigns.
Intervention cost
related to intervention in case of source detection is supported by source
holder or by the state in case of orphan source. The collected source(s) would
be returned to the supplier if possible or transferred to the storage facility.

4.21.3.3.                   
International cooperation and information
exchanges

Portugal
doesn’t contribute to the IAEA Incident and Trafficking Database, but
provides information when requested by other Members States or third countries.

4.21.4.                         
Preparedness and Response
4.21.4.1.                   
Emergency plans and procedures

A national
radiological emergency plan is in force. It covers HASS incidents and orphan
source detection. The emergency services give the first instructions to the
public, ensure the security of the site and mobilize the responders. The unique
contact point is IST.
There is no
structure for 24/7 service, but it is the responsibility of the competent
authority (IST) to give advice and technical assistance whenever an orphan
source is detected. Available equipment is measurement devices, shielded
containers, decontamination material and individual protection equipment. A
team of 4 persons is responsible of the radiological assessment, the transport
of the source, the contamination control of the site after the source removal
and the treatment of the source. 
Holders of HASS
which activity is higher than 1TBq are required to organize a local emergency
preparedness and response plan, but it has not to be approved by the authority.
No such requirement applies to institutions where orphan sources are more
likely to be found.
The emergency plan
has never been activated neither for orphan source detection nor for incident
involving a HASS.

4.21.4.2.                   
Training and information of persons potentially
confronted with an orphan source

According to the
legislation, the training sessions are obligatory and address the complete
information needed to detect sources and safely act in such case. Training and
information are addressed to persons potentially confronted with an orphan
source such as first responder services, scrap yards and metal recycling
plants, waste management facilities and metallurgical industries. Customs
officers are trained but the staffs from transit hubs, harbours and airports
are not trained. 
The training
includes practical exercises with portable measurement device and material. It
is documented and comprehension test is organized, but there is no periodic
review. They are repeated at the request of the holder.

4.22.                               
Romania 
4.22.1.                         
Regulatory framework with respect to HASS
4.22.1.1.                   
Regulatory authority

The national
authority in relation with HASS management is the National Commission for
Nuclear Control Activities (CNCAN) having responsibilities of regulation,
authorization and control in nuclear field in Romania. Other organisations are
the Nuclear Agency and for Radioactive Waste, the National Emergency Situations
Inspectorate and the National Customs Authority.

4.22.1.2.                   
Legislative framework

The law 111/1996
is in force and gives CNCAN competence in the areas of nuclear activities. The
HASS Directive has been fully transposed in the national regulatory framework
in 2008. The reference is the High Activities and Orphan Sources Norm. In
Romania, a new regulation on the radiological monitoring of scrap metal is in
force (regulation NIN-03).

4.22.2.                         
Prevention and Deterrence
4.22.2.1.                   
Authorization for practice with HASS

All topics are
being taken under consideration for giving the authorisation: 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 that have been implemented to prevent damage of HASS by fire,
flooding, etc.

4.22.2.2.                   
Records keeping and updating

HASS holders are
required to keep records of all HASS under their responsibility. This fact is
indicated in an annex to the license and it is mandatory to keep records and
inventories. The HASS holder provides the Authority with the recorded
information periodically (each 6 months). Inspections are performed with the
same frequency. The maximum tolerated delay to provide the information is 15
days. 

4.22.2.3.                   
National inventory

The recorded
information is used to establish a national inventory of authorised HASS
holders and the HASS they hold. For security reasons the information is
provided to the authority only in written copy. The data (all information
requested in the standard record sheet given in Annex II of the HASS Directive)
are processed into a national electronic database (national register). Sources
not covered by HASS directive are also included in the national register. There
are no HASS in Romania which are not covered by the database. 
The register of
authorized source holders is available to customs on request; the register of
HASS is available to police organizations on request.

4.22.2.4.                   
Inspections and penalties 

Inspectors of
CNCAN are in charge of the inspections of HASS holders. Controls concern Safety
(Sf), Security (Sc) and Non-proliferation (NP). The planning is organised
periodically (announced) each 6 months for Sf and Sc and once a year for NP.
Random (unannounced) inspections are foreseen for the three fields.
Follow-up training
in case of an incident or any other suspicious situation is given only for Sf
and Sc.
The inspectors are
trained in all Sc, Sf and NP fields. Their equipment consists of individual
dosimeters; contamination detectors; pictures of typical sources and
containers. The scope of an inspection related to HASS includes for all fields
(Sf, Sc and Np) documentation, inventory, visual inspection of HASS and their
environment, contamination measurements, dose rate measurements of leakage
radiation and security measures. 
The inspections
are directly funded by the State. Penalties in case of infringement are
foreseen. More details on penalties can be found in Chapter VI of the Law
No.111/1996.

4.22.2.5.                   
Control of HASS by the holder

The competent
authority verifies the regular performance of suitable tests by the holder of
each HASS and associated device during inspections. They concern visual
verification, leak test and dose rate measurement.

4.22.2.6.                   
Sources holders’ training

The definition of
the training program of the HASS holder staff is done both by the holder itself
and by an external organisation – recognised by the authority. The
preparation of the training material is developed by both of them. The
frequency of the training sessions varies between 3 to 5 years.
The training
sessions are recorded and a comprehension test is organized. The performance
and efficiency of the training sessions are carried out 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 prompt notification of the authorities in case
of accidents is part of the training and also included as a condition in any
license issued by CNCAN. Non-exposed workers are not included in any kind of
training.

4.22.2.7.                   
Identification and marking of HASS

There is no HASS
manufacturer in Romania. The documentation accompanying an imported HASS
systematically includes the source identification, information and photographs
of source design, source container and transport packaging, information and
photographs of the device and equipment.
The verification
of the correct identification and marking of the HASS is performed during
inspection on site and recorded.

4.22.2.8.                   
Transfers of HASS

The holder
ascertains that the recipient holds the appropriate authorisation by asking a
copy of it. The authority is informed by issuing an authorisation/permit for
the transfer, for the transport and to the recipient in case of a national
transfer. The international transfer is covered by the norms on authorisation
procedures (NSR-03); the transfer, import and export of sources, as well as the
transport of sources has to be licensed by CNCAN. According to NSR-03, the
import and export of a source (not only HASS, but all the sources exceeding the
exclusion levels defined in the Romanian BSS) is not allowed if the recipient
of the source does not have a valid license to receive or possess that source.

4.22.2.9.                   
Long-term management of disused HASS 

According to the
producer prescriptions, the national regulatory framework defines a limited
useful life for HASS. Once this period is expired, the source must be sent back
to the supplier, must be considered either as disused and stored/disposed or
retested for a new working period.
Periodic testing
of the sources is asked by the regulations and performed by each user, the
results of the verification tests being used for revalidation of the license
and controlled during inspections. Disused sources can be stored on site,
provided that safe and secure conditions are ensured by the holder and that a
holding license is issued. In order to force the holders of disused sources to
return them or to send them to a RW storage/disposal, this holding license is
issued for maximum two years.
The preferred
strategy for the long-term management is the return to the supplier of the
disused sources. This is the solution actually implemented.
There is a
national authorized storage facility for radioactive waste located in Baita
Bihor accepting disused HASS. The capacity is adapted to the potential amount
of disused sources. The long-term management of disused HASS is funded by a
fund pre-paid by the holder to the State or competent authority. 

4.22.2.10.               
Security measures

The security
measures that are compulsory should foresee video-surveillance at the place of
use of mobile sources; sources should be locked (not only at the authorised radwaste
storage facility); recorded control access should be done also at the
holder’s premises during storage. Fire detection systems and security
staff should be ensured everywhere.

4.22.3.                         
Detection
4.22.3.1.                   
Detection of orphan sources

Threat assessment
concerning orphan sources at national level has been performed by the competent
authority. The strategic locations have been identified to detect orphan
sources with exception of conventional waste management facilities.
Conventional waste management facilities are not considered to be a strategic
location, since all metal scrap usually goes to metal scrap collecting points.
The detection
equipment available is of portable type and/or portals. The equipment is
imposed and authorised by the competent Authority. The controls are mandatory
in all locations considered strategic. 

4.22.3.2.                   
Campaign for orphan sources recovery

Orphan sources
recovery campaigns have not been organized up to now in Romania. But in the
past, several actions have been performed in order to prevent events involving
orphan sources. These actions have been performed by CNCAN resident inspectors,
as part of their annual inspection plan.

4.22.3.3.                   
International cooperation and information
exchanges

Romania
contributes to the IAEA Incident and Trafficking Database.

4.22.4.                         
Preparedness and Response
4.22.4.1.                   
Emergency plans and procedures

A radiological
emergency response plan is in place in Romania in relation with orphan sources
or HASS. Emergency team is available to intervene 24/7 in case of emergency
with an orphan source or HASS; permanent services are provided by the National
Emergency Situations Inspectorate (IGSU). A unique contact point is designated
in case of detection of an orphan source, with a general emergency call number.
Its coordinates are broadcasted to potentially involved people by information
campaign to general public.
The equipment
available in case of emergency is dedicated vehicles (mobile laboratories),
communication devices, measurement devices and individual protection equipment.

Romanian emergency
response plan has been initiated in 2011 due to orphan source recovery.
There are
compulsory emergency preparedness and response requirements for HASS holders in
place; these emergency response plans and/or procedures have to be approved by
the authority. 
There are also compulsory
emergency preparedness and response requirements for the facility operators of
institutions where orphan sources are more likely to be found, they generally
have the obligation to notify an incident. These emergency response plans
and/or procedures have to be approved by the authority. 

4.22.4.2.                   
Training and information of persons potentially
confronted with an orphan source

A quite extensive
and adequate training and information plan is mandatory for all people who
could potentially be confronted by orphan sources. The training includes
information concerning the potential confrontation with a source, radiation
protection principles, specific requirements for safe management of sources,
possible consequences of loss, theft or inadequate use or damage of sources,
procedures for prompt notification to the competent authority(ies) and
emergency responses in case of (potential) detection/accident, actions to be
taken on site in the event of the detection or suspected detection of a source.
The training courses are obligatory, the training courses have to be approved
by CNCAN, together with the training program and the lecturers and are
documented. They are regularly repeated. Comprehension tests are organized at
the end of the training session. The training sessions do not include practical
exercises. Practical exercises are extensively performed under the
responsibility of the employers.

4.23.                               
Slovakia 
4.23.1.                         
Regulatory framework with respect to HASS
4.23.1.1.                   
Regulatory authority

The Ministry of
Health is responsible for radiation protection and for the related legislation.
The Public Health Authority of the Slovak Republic (PHASR) is the central
authority responsible for all nuclear matters. Besides the central authority,
there are also local authorities. These authorities are issuing licences and
controlling medical sources, industrial sources, workplaces with unsealed
sources and workplaces with high activity sealed sources.
The responsibility
for nuclear safety is by the Nuclear Regulatory Authority of the Slovak
Republic.

4.23.1.2.                   
Legislative framework

Slovakia has fully
implemented the HASS Directive into the national legal framework with reference
Gov. Dec. No. 348/2006.Coll, issued 1st June 2006. The activity levels in the
Slovakian legislation for HASS follow Annex 1 of the HASS Directive. All
sources with activity levels below the high-activity levels are regulated by
Law no. 355/2007 Coll; Gov. Dec. No. 345/2006 Coll. & Decree No. 545/2007
Coll. Before the transposition of the HASS-Directive, sources were covered by
an older legislation.
The main
differences in the requirements regarding the HASS between old legislation and
HASS directive are identification and marking, financial security for orphan
sources and the report on experience.
A HASS stays
covered by the HASS regulation until the activity level falls below the
exemption levels. This is valid also for existing sources at time before the
transposition of the HASS Directive came into force. These provisions are
resulting directly from definition of HASS, which is exactly transposed in
national legislation. Sources are excluded from regulatory control when their
activity is below exemption levels.

4.23.2.                         
Prevention and Deterrence
4.23.2.1.                   
Authorization for practice with HASS

Before issuing an
authorisation for the use of HASS, all relevant issues are considered by the
regulatory authority, including external accidents, emergency procedures and
the long-term management of the disused source. Authorisation is only granted
after all relevant information is received and has been judged by the regulatory
authority as being adequate. An authorisation for HASS has never been refused
in Slovakia.

4.23.2.2.                   
Records keeping and updating

All HASS holders
are required to maintain records of the HASS under their responsibility. A
written or electronic copy of these records is sent to the regulatory
authority. Regulations do not foresee an allowable delay for providing the
records to the regulatory authority.

4.23.2.3.                   
National inventory

There is no
national inventory of sources available in Slovakia. At a regional level,
inventories of HASS are established and maintained by the regional authorities,
based on the licenses granted by them. It is to be noted that only one regional
authority has a complete inventory. In the regions, not all holders have sent
the required records. The holders’ records sent to the regional
authorities are in general not used to compose or complete an inventory of
sources. At present the register of doses is under construction and afterwards
the national register of sources will also be established. 

4.23.2.4.                   
Inspections and penalties 

Inspections are
performed by the local regulatory authorities taking care of only safety
measures. Systematic verification between the records in possession of the
Regulatory authority and the actual situation at the licensee can be performed
for all HASS. Both announced and unannounced inspections exist. In addition
there are inspections as a follow-up in case of an incident or any other
suspicious situation. Inspections cover all relevant items related to safety
only. Regular testing by the licensee on safety performances is part of the
inspection. Inspections are funded directly by the State. Inspectors receive no
special training. The necessary equipment is limited to individual dosimeters
and contamination monitors.
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
€100.000. The system of penalties has not been used up to now.

4.23.2.5.                   
Control of HASS by the holder

The regulatory
authority verifies regular performance of suitable tests by the holder during
inspection. The legislation prescribes acceptance tests, constancy tests (every
three years) and routine tests (every year) for all sources. These are
performed by a national testing company. The intervals and content of tests are
fixed by the testing company (usually according to the recommendations of the
manufacturer) at the acceptance test. The testing company provides once a year
complete information on acceptance, constancy and routine tests with copies of
protocols and copies of certificates to the public health authorities and to
PHASR.

4.23.2.6.                   
Sources holders’ training

The content of the
training program of HASS holder’s staff is defined by the holder. This
training is given at the start of the engagement and repeated yearly. The
training sessions are recorded and there is no comprehensive test organised.
Non-exposed workers and management staff are not trained.
Radiation
protection officer and exposed workers 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. 

4.23.2.7.                   
Identification and marking of HASS

There is no HASS
manufacturer in Slovakia. There is no HASS in Slovakia without ID. Most of the
HASS is come with all necessary signs and with a complete documentation
exceeding the requirements of HASS directive. Identification number can be seen
from documentation that accompanies each HASS. Recommended limited working life
is stated in the certificate accompanying the source.

4.23.2.8.                   
Transfers of HASS

Before the
transfer of a HASS, the holder has to ascertain that the recipient holds
appropriate authorization by requesting a copy of the authorization. The
competent authority would be informed of individual transfers of HASS from the
holder’s records.
Before use of
HASS, the holder must obtain the license (authorization) for use of HASS. Only
a licensed user can obtain, store and use a HASS. The license is issued for
certain number of sources. Individual transfers of HASS between users are
allowed. Usually if any user will purchase a HASS, he will use it and finally
will return it to the supplier or producer. Initial control is done also by the
supplier, who has a duty to control, if the receiver has a license (at least
for the storage until he will receive a license for use).
There is no
evidence of loss or out of control because of unrecorded transfer.

4.23.2.9.                   
Long-term management of disused HASS 

The working life
of a HASS is recommended by the supplier and defined in the source
documentation. The national legal framework does not define a limited useful
life for HASS. An authorisation 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 the transfer to another authorised 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.
The actual situation of disused HASS corresponds to this policy, but it has to
be taken into account that radioactive source storage is not functional at this
time. A storage facility is foreseen. As the national storage facility is not
functional, usually all sources are returned to the manufacturer or supplier.
Storage of disused sources at the holder’s premises is possible for
maximum 12 month.
The long-term
management of disused HASS is solved by “take back” provisions
usually incorporated into the supply contract, by a fund set by nuclear
industry for orphan sources and by a fund prepaid by the holders to the
competent authority.

4.23.2.10.               
Security measures

The competent
authority is informed on the control measures implemented to prevent inadequate
use etc. only during the authorisation process. There is no further information
available regarding security measures.

4.23.3.                         
Detection
4.23.3.1.                   
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 and the metallurgic industry. At these
strategic locations portal and portable detection equipment is available on a
compulsory basis. At borders this detection equipment is also available.
Detection equipment at borders is under responsibility of the Customs Authority
and the Border Police. For detection of orphan sources a portal monitor is
installed at the border to Ukraine to screen railway wagons, as scrap metal is
transported mainly by railway. An additional portal monitor is installed at the
road border checkpoint at the border with Ukraine.

4.23.3.2.                   
Campaign for orphan sources recovery

The regulatory
framework does not ensure that campaigns are organised to recover orphan
sources left behind from past activities. No such campaigns have taken place
and there is a lack of budget, of competent staff and of equipment to do so.
However, it is evident that organising recovery campaigns and using radiation
detection equipment in strategic locations are the best methods to recover the
greatest number of orphan sources. Nevertheless orphan sources have been
recovered and transferred to the authorised interim storage/disposal facility.
There is also a financial strategy for funding the storage of recovered sources
e.g. sources in scrap metal. This is supported by the State.
Additionally an
information campaign was carried out by the Regulatory Bodies at the scrap
metal yards. In this campaign, information about sources, shielding containers
that can be found in scrap, information about risks, methods of protection,
actions how the found orphan sources are recovered and financed were provided
to the employees of the scrap yards. 

4.23.3.3.                   
International cooperation and information
exchanges

Slovakia is
contributing to the IAEA Incident and Trafficking Database (ITDB).

4.23.4.                         
Preparedness and Response
4.23.4.1.                   
Emergency plans and procedures

Slovakia has no
general emergency response plan in operation and there is no emergency team
available as a result of missing human resources and budget. There are
compulsory preparedness and response requirements for HASS holders and these
have to be approved by the authority. There are no compulsory emergency
preparedness and response requirements for institutions where orphan sources
are more likely to be found. There is no unique contact point designed in case
of detection of an orphan source.

4.23.4.2.                   
Training and information of persons potentially
confronted with an orphan source

There is no
training and no information available for personnel potentially confronted with
an orphan source.

4.24.                               
Slovenia 
4.24.1.                         
Regulatory framework with respect to HASS
4.24.1.1.                   
Regulatory authority

There are two
regulatory bodies responsible for HASS in Slovenia: the Slovenian Nuclear
Safety Administration (SNSA) and the Slovenian Radiation Protection
Administration (SRPA). SRPA is responsible for sources and practices in
medicine and veterinary care while SNSA is responsible for sources and
radiation practices other than medicine and veterinary. SNSA also carries out actions and protection measures related to
orphan sources.

4.24.1.2.                   
Legislative framework

Slovenia has fully
implemented the HASS Directive into the national legal framework in beginning
of 2006. The legal and regulatory regime in the country is based on the
Ionising Radiation Protection and Nuclear Safety Act, as amended (Official
Gazette RS, No. 102/2004, and 60/2011). Based on the Act the following decrees
and rules were adopted and transpose the provisions of the HASS Directive:
·        
Decree
UV1 on activities involving radiation, (Official Gazette RS, No. 48/2004 and
9/2006)
·        
Rules
JV2/SV2 on the use of radiation sources and on activities involving radiation,
(Official Gazette RS, No.27/2006),
·        
Decree
UV11 on checking the radioactivity of shipments of metal scrap (Official
Gazette RS, No. 84/2007)
The high-activity
levels defined in the Slovenian regulations for HASS are those of the Annex 1
of the HASS Directive. A HASS stays covered by the HASS provisions until the
activity level falls below the exemption levels. However, existing sources
which would have been declared as HASS before the transposition of the HASS
Directive are covered by the provisions for non-HASS.
All sources with
activity levels below the high-activity levels but above the exemption levels
are also regulated by the above mentioned documents. Due to relatively strict
Slovenian regulatory requirements related to the use of radioactive sources,
only minor amendments of existing legislation were needed for the implementation
of the HASS Directive. The main differences in the requirements regarding the
HASS are records, requirements for the holder and financial security for
sources.

4.24.2.                         
Prevention and Deterrence
4.24.2.1.                   
Authorization for practice with HASS

All HASS are
subject to authorisation. The compliance with transposed provisions of the HASS
Directive is verified through review of prescribed documentation in the
licensing process for the radiation practice and use of sources by the
competent authorities. Before issuing an authorization for the use of HASS, all
relevant issues are considered by the regulatory authority, including external
accidents (fire, flooding, etc.), emergency procedures, long term management
and financial security 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.
An authorization
of a HASS has never been refused in Slovenia.

4.24.2.2.                   
Records keeping and updating

All HASS holders
are required to maintain records of the HASS under their responsibility. A
written copy of these records is to be sent to the regulatory authority at the
time of acquisition of the source through the licensing process. From then on a
yearly update of these records needs to be sent through an annual report of the
licensee. The regulatory authority is furthermore informed of all important
modifications related to HASS (modification of the use or storage, end of use,
transfer, etc.). In practice the periodical records are provided by technical
support organisations, which also perform annual technical checks. Regulations
do not foresee an allowable delay for providing the records to the regulatory
authority. The recorded information supplied by the HASS holder is complete and
is used to establish a national inventory of authorized HASS holders and the
HASS they hold.

4.24.2.3.                   
National inventory

The information
received through these records is used to maintain an electronic national
inventory which is covering all radiation sources. There are no HASS in the
country which are not recorded in the national database or identified in the
holder’s records.
The register of
authorized source holders is available to customs and police organizations on
request. 
During
inspections, a systematic verification between the records in possession of the
regulatory authorities and the actual situation at the licensee is performed
for all HASS.
The original
documentation is kept by the holder of HASS and is presented during inspection.

4.24.2.4.                   
Inspections and penalties

Inspections are
funded directly by the State and are performed by inspectors of the SNSA and
SRPA at the HASS holders in respective area of their competence. The
inspections deal with both safety and security aspects. There are inspections
as a follow-up action in case of an incident or any other suspicious situation
such as the report by TSO of incompliance. Inspectors receive training in all
relevant fields, including practical experience in metrology and the necessary
equipment for performing an inspection is available. 
As a legal
requirement, the HASS and their containers/equipment are controlled by two
authorised technical support organisations (TSO) every year at the cost of
holder in addition to inspection. The scope of inspections carried out by the
inspectors or the TSO covers documentation, inventory, visual inspection and
measurements.
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 € 250.000. The system of penalties has been used once up to now. 

4.24.2.5.                   
Control of HASS by the holder

Regular tests of
HASS carried out by the holder include visual verification and dose rate
measurements. The measurements are necessary for the evaluation of the
radiation protection of exposed workers. The performance of the control is
checked during inspection. Moreover, supervision and leak tests (contamination
measurements) are performed once a year by the recognized TSO which
systematically informed the regulatory authorities by sending a report.
The competent
authority is informed on the control measures to prevent inadequate use, loss
or theft or damage of the sources during authorization process, by regular
reporting by both the holder and the recognized TSOs as well as during
inspections.

4.24.2.6.                   
Sources holder's training

The content of the
training program for exposed workers and RPO is defined by the rules on the
obligations of the person carrying out a radiation practice and person
possessing an ionizing radiation source (SV8 - Official Gazette RS, No.
13/2004). The training is carried out by organizations recognized by the
regulatory authority. Only radiation protection officers and the exposed
workers are trained, not the managerial staff nor the non-exposed workers.
The training
material is prepared by a recognized organization and the lecturers and the
training sessions are recorded. The training is repeated every 2 or 5 years and
trainees have to pass a written test. Radiation protection officer and exposed
workers 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.

4.24.2.7.                   
Identification and marking of HASS

Usually the
documentation accompanying the HASS is complete and includes source
identification, information and photographs of source design type, of typical
source container, of transport packing and of device and equipment. To the
knowledge of the regulatory authorities, there is no HASS without
identification number in Slovenia. The identification number of the HASS is
found in the documentation that accompanies each HASS and of which a copy is transferred
to the regulatory authorities during the licensing process. The original
documentation is kept by the holder of HASS but must be shown during
inspection.

4.24.2.8.                   
Transfers of HASS

The HASS can be
transferred to another licensed Slovenian radiation practitioner. All transfers
are notified to the competent authority. In case of transfer of HASS to the
country outside of the EU, the competent authority of country of destination is
notified in advance about such transfer. Before the transfer of a HASS, the holder
ascertains that the recipient holds appropriate authorization by direct contact
with the national authority of the recipient’s country.
No situation with
a HASS lost or out of control due to unrecorded transfer has been encountered
in Slovenia. The only exception is the loss of two old lightning rods (in 2010;
the SNSA reported into IAEA ITDB).

4.24.2.9.                   
Long-term management of disused HASS

The Slovenian
regulatory framework defines a limited use for HASS which depends on the
application and license. The holder is forced to make long term management
arrangements after termination of HASS use because authorization is issued only
if the long-term management route is already specified and planned and also
because routine re-authorizations for the re-use of HASS are obligatory. The
country’s policy on disused sources gives first priority to returning the
disused source to the supplier. In the case of the disused source cannot be
returned to the supplier, it shall be transferred to the Central Storage
Facility for Radioactive Waste. A HASS can be also transferred to another
licensed user.
Short-term storage
of disused sources at the holder’s premises is authorised but for a
limited period of three months.
The national
centralised waste storage facility accepts disused sources and its capacity is
adapted to the potential amount of disused sources.
The long term
management of disused HASS is funded by the holder, via a bank guarantee or
insurance policy issued during the licensing process. The state shall assure
financial resources for the management of orphan sources.
Up to now no
situation dealing with disused sources without any long-term management
solution has occurred.

4.24.2.10.               
Security measures

For the HASS it is
explicitly requested to provide evidence in the licensing process that security
measures are assured. However, security measures are not specified in detail in
the Slovenian regulations or in the licenses. 

4.24.3.                         
Detection
4.24.3.1.                   
Detection of orphan sources

Slovenia has a
good overview of all radioactive sources on its territory. In recent years
efforts were made to bring sources at museums, universities and institutes
under regulatory control. An overview regarding orphan sources was performed by
the SNSA and its stakeholders, yielding at the identification of the strategic
locations for finding orphan sources: metal scrap yards, metal recycling
facilities, metallurgic industry, conventional waste management facilities,
borders/customs, harbours, transit hubs, military sites and museums.
Most of these
locations are equipped with portal or portable detectors. The main concern
being the orphan sources in imported scrap metal shipments, all imported scrap
metal shipments are subject to radiometric survey. All main smelters and scrap
dealers are equipped with portal monitors and hand-held detectors. The
requirements for compulsory detection equipment are laid down in the
legislation. In case of discovery, orphan sources are returned to the country
of origin. If the evidence about the origin is insufficient it is stored in the
Central Storage Facility for Radioactive Waste. 
At the other
strategic locations identified, the installation of detection equipment is made
on a voluntary basis. 

4.24.3.2.                   
Campaign for orphan sources recovery

The regulatory
framework ensures that campaigns are organized. Such campaigns have taken place
in Slovenia even if no special budget or staff is dedicated for this purpose.
Organizing specific and focused actions was the most effective type of recovery
campaign.
The following
actions have been realized or are planned: systematic analysis of the
historical records at the regulatory authority, investigation in the
manufacturer's records, investigation in the former holder's records,
systematic inspection of facilities, specific campaigns in universities,
research centres, material testing facilities, scrap yards, metal recycling
facilities, metallurgic industries and former military sites. 
The state shall
assure financial resources to cover the costs related to further management of
source and for mitigation of eventual radiological impact caused with such
source if the owner is not known. 

4.24.3.3.                   
International cooperation and information
exchanges

Slovenia 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) since 1999. 

4.24.4.                         
Preparedness and Response
4.24.4.1.                   
Emergency plans and procedures

Slovenia has a
general emergency response plan in operation, also applicable to orphan sources
and HASS. Procedures aimed at taking measures in case of discovery of an orphan
source (elevated radiation) or mitigation of eventual emergency, are in place.
The responsibilities of participating parties are clearly assigned. 
An emergency team
of Civil Defence with adequate equipment is available 24/7. There is a unique
contact point designed in case of detection of an orphan source with a
dedicated emergency call number. Its coordinates are broadcasted through SNSA
website to emergency services and people of organisations likely to be
confronted with orphan sources. The Slovenian emergency plan has not been
initiated so far due to orphan sources or an incident with HASS. 
HASS holders have
to implement on-site emergency procedures which need to be approved through
licensing process. On the holder's level, emergency requirements are obligatory
for its own employees. However, there are no compulsory requirements for the
facility operators of institutions where orphans sources are more likely to be
found. 

4.24.4.2.                   
Training and information of persons potentially
confronted with an orphan source

A quite extensive
and adequate training is mandatory for all workers who could potentially be
confronted by orphan sources. However, there is no obligatory training for the
management. The training is also not mandatory for police and customs although
the training is provided to them on a voluntary basis. The training sessions
are documented and repeated periodically. A comprehension test is organised for
the obligatory training courses, but not for stakeholders being involved
voluntarily. The emergency trainings include also practical exercises using
pictures of typical sources and containers, hand-held instruments and portal
detectors if available at the place where the session is organised.

4.25.                               
Spain 
4.25.1.                         
Regulatory framework with respect to HASS
4.25.1.1.                   
Regulatory authority

The primary
regulatory authority in the field of safety and security of ionising radiation
sources in the country is the Consejo de Seguridad Nuclear (CSN). Its main
functions related to HASS include safety assessment in the licensing process,
supervision and control. These functions are not limited to HASS, but cover all
ionising radiation sources. Other functions of CSN include training and
information, recording, reporting and international cooperation. 
Enforcement and
financial aspects of orphan sources are however covered by the two other
organizations involved with HASS safety and security, i.e. the Ministry of
Industry, Energy & Tourism (MIET) and the regional Authorities in charge of
industry. These regional authorities have activities in the fields of
transferring of HASS, records keeping and enforcement (penalties). The MIET
however is also involved in all regulatory activities, especially in the field
of non-proliferation. The management of radioactive waste is the responsibility
of ENRESA. 

4.25.1.2.                   
Legislative framework

The legislative
framework in the country is based upon the Law on Nuclear Energy (Law 25/1964
of 29th April 1964) with its subsequent modifications. The legislative
framework is further completed by two other laws:
·        
Law
creating the Nuclear Safety Council (Law 18/1980 of 22nd April, amended by Law
33/2007 of 7th November 2007) and the corresponding Royal Decree approving the
Statute of the Nuclear Safety Council (Royal Decree 1440/2010 of 5th November
2010);
·        
Law
governing Public Prices and Fees for Services Rendered by the Nuclear Safety
Council (Law 14/1999, of 4th May 1999).
The HASS Directive
is fully implemented into the Spanish regulations. The same definition and
related radiological criteria are being used for defining HASS. However, it
seems that for practical implementation, the actual activity of the source is
used instead of the activity at the moment of production of the source.
The main
differences between HASS and non-HASS at the level of the records are the
periodic testing by the holder, the identification and the labelling and at the
level of the financial guarantees. 
As the main
difficulties encountered during the implementation of the HASS Directive, Spain
reports the discrepancy that exists between the EC and IAEA source
classification and the construction of the HASS inventory. However a web-based
system for filling out the information is available, allowing users to upload
the information into the database.

4.25.2.                         
Prevention and Deterrence
4.25.2.1.                   
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, etc.),
emergency procedures and the long term management of the disused source.
Authorizations for HASS have already been refused due to failure to comply with
regulatory requirements. 

4.25.2.2.                   
Records keeping and updating

All HASS holders
are required to maintain records of the HASS under their responsibility. A
written and an electronic copy of these records are to be sent to the
regulatory authority at the time of acquisition of the source. Further-on a
yearly transfer of these records to the regulatory authority is required. Finally,
once the holder transfers in any way the HASS, the regulatory authority is
again sent a copy of the corresponding records. In general the information
transferred to the authority in this way is considered to be complete. There is
however no maximal delay defined in the regulations for sending the updated
records.

4.25.2.3.                   
National inventory

The information
received through these records is used to maintain an electronic national
inventory which is covering only HASS. Information on the other radiation
sources can be found in the separate non-electronic database on licensed
facilities. The national register is currently not available to law enforcement
authorities (police and customs).

4.25.2.4.                   
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. These verifications are carried out annually for all HASS.
Inspections are performed by the regulatory authority (CSN) in the fields of
safety and security of radiation sources, whereas the MIET is responsible for
the inspections in the field of non-proliferation. As a general rule,
inspections are announced to the licensee and are performed yearly. In general
there are no unannounced inspections or inspections organized as part of
follow-up actions after incidents or accidents. Inspections cover all relevant
items for safety and security of the HASS. The inspections are funded through
an annual tax linked to the authorization. Inspectors receive training in all
relevant fields, including practical experience in metrology. The necessary
equipment for performing an inspection is available.
In case of
non-respect of regulations, a system of administrative penalties is in place.
These administrative penalties depend on a very detailed system of different
types of infractions and can range from €1200 to €600,000. The
system of penalties has reportedly already been used. 

4.25.2.5.                   
Control of HASS by the holder

Regular testing by
the licensee of safety and security performances are required by the regulatory
authority: monthly visual verification and yearly leak testing. The correct
performance of these tests is verified during the inspections. The precise
content of these tests for different types of sources is described in a
technical guidance published by CSN.

4.25.2.6.                   
Sources holders’ training

HASS holder’s
staff requires a comprehensive training, of which the detailed content is
defined by the holder himself. These trainings, without comprehension test, are
given yearly to the radiation workers. The training records are checked by the
regulatory authority during the inspections. 

4.25.2.7.                   
Identification and marking of HASS

HASS need to be
systematically accompanied by the necessary documentation. This documentation
contains all relevant information. As there are no HASS manufacturers in Spain,
all HASS are imported. HASS arrive without a recommended working lifetime for
the source.

4.25.2.8.                   
Transfers of HASS

In case of
transfer of HASS, the regulatory authority is informed of the transfer either
through the request of an authorisation by the recipient of the source, either
through the records of the sender and the recipient that have to be sent to CSN
immediately after the transfer. If this system would fail, the transfer of the
source will be discovered during the yearly inspections. In case of an
international transfer, the holder transferring a HASS needs to verify that the
recipient holds a valid authorization for the possession of the source. This
can be done either by requesting the license from the recipient, either through
direct contact with the national competent authority of the country of the
recipient (compliance with EURATOM Regulation 1493/1993 and/or Guidance for the
import and export of radioactive sources attached to IAEA Code of Conduct is
required).
No cases where
HASS got out of control during transfer are known to the regulatory authority.

4.25.2.9.                   
Long-term management of disused HASS 

With respect to
the long-term management of HASS, the national regulatory framework in Spain
does not define a recommended working life. The authorization process for HASS
takes also into account the adequacy of the long term management of the disused
sources. An authorization will only be issued if the long term management route
is already specified and planned. This long term management option also needs
to be covered by a financial guarantee. A list of financial instruments that
can be used for setting this financial guarantee was published by CSN on its
website. However, the precise amount of this financial guarantee is not
precisely fixed and the physical availability of the amount is not absolutely
required. 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 for re-use in another application.
Transfer to an authorized waste treatment or storage facility is only
considered as last possibility. The actual situation of disused HASS shows
however that a more important number of sources are transferred to the waste
facility than are being reused in other applications.
Today, the
long-term management of HASS is organised through take-back provisions
incorporated in the supply contracts and funded through the above-mentioned
financial guarantees to be foreseen by the holders of sources. Additionally,
ENRESA manages a fund for waste management which can be used in very specific
situations for the management of licensed sources or for orphan sources. 

4.25.2.10.               
Security measures

A technical
regulation on minimal compulsory security requirements for radioactive sources
has been drafted and published in June 2013.

4.25.3.                         
Detection
4.25.3.1.                   
Detection of orphan sources

A threat
assessment regarding orphan sources is currently being organized. Strategic
locations for finding orphan sources currently considered are: metal scrap
yards, metal scrap recycling facilities, metallurgical industries and harbours
and airports. All of these, and additionally the conventional waste management
facilities, currently have available, on a voluntary basis, portal monitors for
detecting radioactive sources. Portable radiation detectors are not considered.
Also at border crossings no portal monitors are available to the customs (no
land borders outside of EU). The regulatory authority is not authorizing this
equipment, but a national co-operation protocol between de authorities and the
metal sector companies has been implemented.

4.25.3.2.                   
Campaign for orphan sources recovery

The regulatory
framework foresees the organization of recovery campaigns for orphan sources as
appropriate and such campaigns have been organized. Financial resources are
considered appropriate for this type of campaigns. Recovery actions so far have
been based on the historic records available at the authorities, the former
source manufacturers, the suppliers and the (former) licensees, and using the
results of the site inspections. Specific campaigns have been organized in
hospitals, medical practitioners’ offices, schools and universities,
research centres, material testing facilities, mines and at former military
sites. Recovery campaigns are considered to be an efficient method for
recovering important numbers of orphan sources. The most recent recovery
campaign was organised from 2008 and lasted for 3 years. 

4.25.3.3.                   
International cooperation and information
exchanges

Spain is
contributing to the IAEA Incident and Trafficking Database (ITDB) since its
creation. 

4.25.4.                         
Preparedness and Response
4.25.4.1.                   
Emergency plans and procedures

Spain has an
emergency response plan applicable to HASS in place. It has not been necessary
to activate this plan as a result of problems with HASS or orphan sources. HASS
holders also require an on-site emergency response plan, which needs to be
approved by the authority. Installations in which orphan sources are more
likely to be found do not require an internal emergency plan. 
In case of
emergencies involving HASS or orphan sources, the regulatory authority has an
emergency team available to intervene 24/7. This team has full radiological
intervention equipment available, except for decontamination material. This
team is reached through the general emergency phone number. Emergency services
and institutions likely to be confronted with orphan sources have the emergency
phone number of the regulatory authority available. Up to now the national
emergency plan has not been initiated in Spain in relation to situations
involving HASS or orphan sources. 

4.25.4.2.                   
Training and information of persons potentially
confronted with an orphan source

A quite extensive
and adequate training and information plan, including practical exercises,
exists for all people who could potentially be confronted to orphan sources and
this for most of the cases both at the level of the workers as at the level of
the management. These training sessions however do not seem to exist at the
level of customs and transport personnel. These training sessions are not
mandatory and are not regularly repeated. There is no comprehension test
organized. 

4.26.                               
Sweden 
4.26.1.                         
Regulatory framework with respect to HASS
4.26.1.1.                   
Regulatory authority

Regulatory control
of radioactive sources is stipulated by the Radiation Protection Act
(1988:220). According to this Act, the competent nuclear authority is the
Swedish Radiation Safety Authority (SSM). The SSM is responsible for all the
requirements of the HASS Directive except for the juridical and transposition
matters which are made through SSM: the State is responsible and SSM as the
competent authority has the right to issue regulations based on the Swedish
Radiation Protection Act (1988:220) and ordinance (1988:293). Penalties are
given in the law that is issued by the parliament. The government issues the
ordinance.

4.26.1.2.                   
Legislative framework

The HASS Directive
has been transposed into the Swedish regulatory framework primarily through
SSMFS 2008:9 as well as SSMFS 2008:10 and SFS 2007:193 and also through minor
legislative adjustments of the Radiation Protection Act (SFS 1988:220).
Additional security regulation is in progress but is closer to IAEA CoC
security and safety of radioactive sources. 
The definition for
a high-active source (and activity levels) used in the Swedish regulatory
framework is the same as the one from the HASS Directive. A HASS falling below
the defined high-activity levels is still covered by the law for HASS in
accordance with the Directive, until exemption. A source is released from
regulatory control when its activity level is below the national clearance
levels.
The fundamental
regulations for any radioactive sources are in the Radiation Protection Act
(1988:220) and Ordinance (1988:293) and in addition in SSMFS regulations (and
sometimes also in licence specific requirements). For non-HASS, licences are
issued for holding an activity above the exemption level of EU-BSS.
Before the
transposition of the HASS Directive, all sources were regulated but with
lower/other requirements. The main differences between the old version and
amended one are to be found in records keeping, requirements for holders,
identification and marking, training and information, orphan sources, financial
security for orphan sources and international cooperation and information exchange.

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 law for non-HASS.

4.26.2.                         
Prevention and Deterrence
4.26.2.1.                   
Authorization for practice with HASS

Before issuing an
authorisation for the use of a HASS, all relevant items are considered by the
Regulatory Authority. Until now, the SSM has never refused an authorisation for
use of a HASS.

4.26.2.2.                   
Records keeping and updating

Each HASS Holder
has the obligation to keep records of all HASS (and all radioactive material)
under its responsibility. According to the legislation, the holder has to
provide the SSM with the recorded information at the acquisition time,
annually, when the holder no longer holds or uses the source and when
conditions specified in a record sheet have changed, within one week. However
the practical handling routine delay is about 1 month. 
The information is
transferred both electronically and through hard copy.
SSM 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. Thus the
information of all sources is gathered in one database.

4.26.2.3.                   
National inventory

According to SSM
all HASS are required to be registered in the national database. Due to other
reasons however some HASS may unintentionally escape registration.
The register of
authorized sources holders and of HASS is available to customs organisations
and to police only on request. 

4.26.2.4.                   
Inspections and penalties 

During
inspections, the authority (SSM) has access to the holder’s records. The
match between these records and the actual situation of the HASS is checked.
During an inspection, the HASS records vs. actual situation are thus either
comprehensively (for each HASS) or partially (on a certain number of sources)
verified according to the inspection planning of the authority. 
Inspection looks
at safety (and security) fields. Non-proliferation is restricted to fissile
material/nuclide in accordance with regulations for non-proliferation.
Inspections are announced to the licensee and realized according to annual
inspections planning but due to limited resources without a regular frequency.
Inspections are also held as follow-up action in case of incident or any other
suspicious situation. Inspection scope covers documentation, inventory,
organization, competence check and visual inspection of HASS and their
environment. No measurements are realized and the security measures are not
considered. There is an annual fee for all licensees that should cover all the
costs for the competent authority.
Safety inspectors
are trained for visual detection of sources and containers, safe management of
sources and procedures for prompt notification and emergency response. Actual
training is on-the-job led by experienced inspectors, but formal training
should be available soon. The focus of inspections is to check the conformance
with applicable regulations. No measurements are made by the inspectors.
Penalties are
foreseen in case of violation of the regulations. It is up to a court to decide
about the type and range of penalties based on the interpretation of the law. 

4.26.2.5.                   
Control of HASS by the holder

Tests carried out
by the holder to ensure the good conditions of each HASS are visual
verification and leak tests (no dose rate measurement) carried out annually.
Leak tests may be carried out by competent contractors. The results of the tests
are communicated to the competent authority. The licensee must report to the
authority in accordance with regulations (i.e. through the standard record
sheet).
The security
measures required in regulations are examined during inspections and through
regular reporting by the holder. 

4.26.2.6.                   
Sources holders’ training

The legislation
stipulates that the holder shall conduct regular training of the personnel
involved in the practice using the source. Such training shall in particular
encompass locally established rules for safe handling of the source and
potential consequences should the source be lost or damaged. Completed training
shall be documented. 
The content of
training is the responsibility of and defined by the holder. The authority sets
the regulations but no detailed instructions are given within. It is up to the
holder to follow the regulations and ask for guidance if needed. The holder may
engage a third party to prepare and give the training. Only exposed workers are
trained on radiation protection principles, specific requirement for safe
management of sources, prompt notification to competent authorities and
emergency procedures and rules for potential consequences in case of loss or
damage. 
The frequency is
decided by the holder and usually depends on personnel turnover and
holder’s judgment. The trainings are not recorded and no requirement is
made for a comprehension test. 

4.26.2.7.                   
Identification and marking of HASS

According to the
legislation, HASS should be systematically accompanied by the relevant documentation.
When new sources are taken into the country by a licensed trading company all
the documentation are actually present. A significant number of HASS holders
have sources manufactured before the HASS regulations that may be less complete
in documentation. 
There is no more
HASS manufacturer in the country. For imported HASS some producers recommended
a working life (usually about 10 years with possible repeated extensions). 
There are cases of
HASS without identification or information on its nature in the country. These
are older sources which may not have ID numbers. 

4.26.2.8.                   
Transfers of HASS

In accordance with
regulations and Euratom 1493/93, the regulatory authority is informed of the
transfer because a license needs to be requested by the recipient of the source
and because the holder needs to have a permit for the transfer and transport.
The records of the holder also show indication of the transfer. 
The holder
transferring a HASS has to check that the recipient holds a valid authorization
for the possession of the source. 
No cases where
HASS go out of control during transfer are known to the regulatory authority.

4.26.2.9.                   
Long-term management of disused HASS 

Concerning the
long-term management of HASS, no limited working life is defined in the
national regulatory framework. If the producer sets a working limit, it can be
used as an indirect limit during the licensing process. 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. The next preferred option is the transfer of
the source for re-use. If this would not be possible, the source should be
considered as radioactive waste and be transferred to an authorized waste
treatment or storage facility. Disused sources can also be stored at the
holder’s premises for a period of maximum 6 months. Individual
prolongation set by the authority is also an option (e.g. for universities that
cannot find any receiver for their sources).
Cases of disused
sources (not only HASS) without long-term management solution are known to the
authority. Also cases without any financial solution have been solved by
transfer to another user. 
A national
authorized storage facility for radioactive waste is available in the country
and is managed by a private company. It doesn’t accept all type of
sources/HASS. Its capacity is considered adapted to the potential amount of
disused sources on a commercial national basis. 
Currently the
long-term management of disused HASS is funded through a fund set by the holder
(bank guarantee or equivalent).

4.26.2.10.               
Security measures

Currently, the
security requirement for installations where HASS are present is locked
premises and lock on the source (also at the working site temporary storage in
case of mobile use such as industrial radiography). Security regulations are in
progress. 

4.26.3.                         
Detection
4.26.3.1.                   
Detection of orphan sources

No comprehensive
risk/threat assessment regarding orphan sources has been performed by the regulatory
authority but this issue is currently in discussion. Strategic locations
identified on indication or information are: metal scrap yards, metal scrap
recycling facilities, conventional waste management facilities,
borders/customs, harbours, transit hubs and airports. 
Detection
equipment at some strategic location for finding sources is present on
voluntary basis encouraged through information to scrap dealers, smelter
industry, customs and first responders on the possibility of such sources and
through promoting the importance of detection and actions to take if detected.
The producer’s responsibility for orphan sources is described in
Ordinance SFS 2007:193. The used equipment has not to be authorized by the
competent authority. In that context, portals are present in metal scrap yards
and metal recycling plants, the last place being also equipped with portable
equipment. Portable equipment is also present in conventional waste management
facilities and harbours. There is no monitoring equipment at the borders.

4.26.3.2.                   
Campaign for orphan sources recovery

No recovery
campaign has been organized in the country but discussions are ongoing. The
private sector will probably become involved through technical contribution. No
specific budget is dedicated for this topic but there is some money available
to pay for discovered sources handled by the authority.

4.26.3.3.                   
International cooperation and information
exchanges

Sweden 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).

4.26.4.                         
Preparedness and Response
4.26.4.1.                   
Emergency plans and procedures

Sweden has a
national radiological emergency response plan dedicated to orphan sources or
HASS. The emergency organisation for nuclear accident also handles other
radiological events that falls outside the ordinary authority organisation. The
nuclear emergency team has all adequate material except shielded containers and
decontamination material. The team can be reached through the general emergency
call number (112) or directly by phoning to SSM.
The HASS holders
are required to report events with HASS but are not required to have emergency
preparedness and response plans in any more explicit meaning. Similarly there
is no requirement for institutions where orphan sources are likely to be found.

4.26.4.2.                   
Training and information of persons potentially
confronted with an orphan source

Training of
personnel at the licensee is required but not for other persons potentially
confronted with an orphan source. Rescue services and similar personnel may
have training through other channels but not based on Radiation Safety
Authority regulations. 

4.27.                               
United Kingdom 
4.27.1.                         
Regulatory framework with respect to HASS
4.27.1.1.                   
Regulatory authority

The controls over
HASS are principally the concern of the environmental regulators in the UK, who
also maintain the UK’s national inventory of HASS. Permits are issued and
enforced by the relevant environmental regulator within the UK:
·        
Environment
Agency (EA) for undertakings in England and Wales; 
·        
Scottish
Environment Protection Agency (SEPA) in Scotland;
·        
Northern
Ireland Environment Agency (NIEA) in Northern Ireland.
The HASS Directive
requirements were transposed through environmental legislation in the UK. The
Health and Safety Executive (HSE), which is responsible for safety in the
workplace throughout UK, also has an interest in the control of HASS, as
undertakings using HASS also need to comply with requirements set out in the
Ionising Radiations Regulations 1999 (mainly relating to worker safety and the
prevention of accidents). On nuclear sites, the holding of sealed sources/waste
sealed sources is regulated under the Nuclear Installations Act 1965, and
enforced by the Office for Nuclear Regulation (ONR). The ONR is the nuclear
safety regulator for the civil nuclear industry in the UK, and is an agency of
the HSE. 

4.27.1.2.                   
Legislative framework

In the UK,
legislation has been in place to regulate the use of radioactive substances and
the disposal of radioactive waste since 1948, with major revisions in 1960,
1993 and 2011. The principal piece of legislation dealing with nuclear
installations (licensing, controlling the nuclear plants, liability for nuclear
damage) is the Nuclear Installations Act 1965, and amendment.
Council Directive
2003/122/Euratom was fully transposed into UK legislation through the
High-activity Sealed Radioactive Sources and Orphan Sources Regulations 2005
(Statutory Instrument 2005 N°2686), which came into force on the 20th October
2005. These regulations remain in force in Scotland and Northern Ireland.
England and Wales incorporated the control of HASS provisions in the
Environmental Permitting Regulations (EPR) 2010, which were subsequently
amended by the Environmental Permitting Regulations 2011, which came into force
on 1st October 2011. The authorisations issued for HASS in the UK include
conditions to cover the requirements of the HASS Directive, in addition to
those of the Basic Safety Standards Directive (BSSD).
The main Laws and
Regulations related to the protection of people and the environment in relation
to radioactive sources are:
·        
Radioactive
Substances Act 1993 in Scotland and Northern Ireland, 
·        
High-activity
Sealed Radioactive Sources and Orphan Sources Regulations 2005, now included in
(1) and (3),
·        
Environmental
Permitting Regulations 2010, and
·        
Ionising
Radiations Regulations 1999.
The regulatory
framework uses the definition of the HASS Directive for High Activity Sealed
Source. A HASS stays covered by this law until decay to the European BSSD
exemption values (Directive 96/29/Euratom). Sources purchased with activity
levels below the HASS threshold are controlled by the general requirements of
the Environmental Permitting Regulations 2010 in England and Wales and the
Radioactive Substance Act 1993 in Scotland and Northern Ireland. The main
additional controls applied to HASS are the requirements related to
authorisation (article 3§2 adequate arrangements and financial provision for
management of disused source), transfers (article 4), orphan sources (article
9), financial security of orphan sources (article 10), international
cooperation and information exchanges (article 11) and report on experience
(article 14).

4.27.2.                         
Prevention and Deterrence
4.27.2.1.                   
Authorization for a practice involving HASS

Before issuing an
authorisation (permit) for the use of a HASS, the authorities ensure that all
arrangement and provisions of Article 3 “Authorisation” of the
Directive are met. In broad terms the conditions are based on suitable
arrangements in the management system for: resources (including sufficient
competent and trained persons); sources which become disused or are
transferred; the maintenance of the security and integrity of sealed sources
(checked by suitable tests) and finally record-keeping.
Permits have been
refused for use of a HASS because the holder had no ability to provide
financial provision for the disused source.

4.27.2.2.                   
Records keeping and updating

The
authorisation/permit requires HASS holders to keep records of the sources, and
provide the recorded information to the authority, at        the time of
acquisition, annually (by the end of January), when the holder transfers the
source and at the disposal of the source. 
The regulator must
be informed within 14 days, and this is generally respected. The information is
transferred through written copy. Checks are made during annual inspections.

4.27.2.3.                   
National inventory

The complete
information of the standard record sheet is recorded in a secure electronic
database. This national inventory is considered as complete. The database was
established specifically to meet the HASS Directive requirement, and tracks the
transfers of all HASS from acquisition to disposal, but it was not designed to
produce a total inventory or summary reports by sector. The total number of
HASS changes daily and the total number of HASS at any given time is not
calculated or reported.
This inventory is
available, by country, for inspection by competent authorities, and would be
communicated on request to Police and customs organization. Authorities check
the match of recorded information and actual situation during inspection for
each HASS site at least every 12 months.

4.27.2.4.                   
Inspections and penalties 

Environment Agency
SEPA and NIEA inspectors carry out annual inspections on each HASS site, and as
follow-up action in case of incident or in any other suspicious situation.
Inspections are funded by annual charges linked to the authorisation. 
The scope of these
inspections includes safety and security aspects such as documentation,
inventory, visual inspection of the HASS and their environment and security
measures. Inspectors verify the regular performance of suitable leak tests by
the holder. They do not control the potential contamination or dose rate of the
equipment. 
The training of
the inspectors carrying out such inspections includes practical experience in
radiation protection, safety precautions, the visual recognition of sources and
containers and the specific requirements for their safe management, possible
consequences of loss, theft or inappropriate use of sources and
procedures/responses to be followed in case of emergency situation. 
Enforcement and
prosecution policies are published by the environmental regulators, and
national legislation identifies offences and maximum penalties ranging from
fines to two to five year imprisonment). 
There have so far
not been any prosecutions in the UK in relation to HASS offences.

4.27.2.5.                   
Control of HASS by the holder

Leak tests are
carried out by, or on behalf of, the holder at a frequency no longer than two
years. Frequency of visual inspection is not defined. It depends on the use and
the location of the source, but some verification of whereabouts will be
expected during the annual inspection. The competent authority is informed on
the control measures to prevent any incident involving the HASS during the
authorisation process, and these measures are checked during inspections.

4.27.2.6.                   
Sources holders’ training

The training of
the HASS holder’s staff is defined by the holder (programme, categories
of trained workers, material, frequency, organization, records and tests) in
consultation with qualified expert approved by the authority. The competent
authority checks the training records during inspection.
The UK has
established a system of recognised “Radioactive Waste Advisers”
(RWAs) who are approved against a set level of experience and training. RWAs
are appointed by the holders.

4.27.2.7.                   
Identification and marking of HASS

The documentation
accompanying the HASS is generally complete including the source identification
(on the source and on the container) and all relevant information concerning
the source design, the container, the transport packaging and the associated
device or equipment.
The correct
identification and marking of the HASS is not currently directly verified by
the regulators, reliance is placed on the manufacturer's QA system and the
documentation provided. However, the Environment Agency has published guidance
entitled “How to comply with your EPR RSR environmental permit –
sealed sources”, which states: “No HASS manufactured after 31
December 2005 shall be brought onto the premises unless all the information
concerning identification and marking of the source and container are
provided”.

4.27.2.8.                   
Transfers of HASS

Before the
transfer of any HASS the holder shall prepare and provide to the recipient
written information indicating identification number, how it is marked, details
of its radioactive content, and, where appropriate, the identification number
of the source container. The holder transferring a HASS must ask for a copy of
the recipient’s authorisation before transfer, this is to ensure that the
recipient is entitled to receive HASS sources. The recipient must have an
authorisation from the competent authority. It is an offence to receive HASS without
the appropriate permit.
The regulator is
informed of individual transfers of HASS from the records of the holder. Where
a source is transferred to a nuclear site licensee for long-term storage or
final disposal, a receipt shall be obtained from the recipient and a copy
provided to the authority as soon as reasonably practicable.
There has been no
case of a source lost or out of control due to unrecorded transfer; however,
there has recently been a case of theft of a HASS from an authorised
courier’s vehicle.

4.27.2.9.                   
Long-term management of disused HASS 

Some suppliers
provide Recommended Working Live (RWL) but this information is not an element
of the national regulatory framework.  
Where suppliers
specify Recommended Working Life, a review of continued use of the source is
carried out at the end of the RWL. The holder should take appropriate steps to
confirm the integrity of the source capsule and plan for the replacement and
disposal of the source. This RWL information is used by regulators as part of
the “leverage” to get sources disposed of promptly. It is for the
user to justify the continued use of a source beyond its RWL.
The disposal
arrangements for each category of HASS must be specified and planned before the
authorization or delivery of a HASS. The HASS holder must have either a
“take-back” agreement incorporated into the supply contract, or
make financial provision for the long-term management/disposal of the source.
The UK has accepted take-back agreements in source supply contracts as a suitable
mechanism for end of life management of certain categories of sources. 
For HASS, the UK
has established a panel of experts so called the HASS Financial Provision Panel
to approve proposed mechanisms for financial provision for HASS disposal. This
HASS Financial Provision Panel checks that arrangements are robust to
insolvency of the applicant. If the financial provision is needed due to
insolvency, the funds are managed by the regulator. 
The options for
long-term management of a disused source are, by order of preference: re-use by
another authorized holder; return to supplier; and finally collection as waste.
In practise, re-use is not always attainable.
HASS of
significant half-life that are not re-used or returned to the supplier are
eventually transferred after packaging/conditioning/intermediate-storage to the
UK's principal store for intermediate level waste at Sellafield. Waste HASS are
a very minor addition to the waste from the nuclear sector, no special adaption
is required. Though storage capacity is not an issue, access to shielded
facilities to unload sources can be a restriction at time. Eventually waste
HASS in long-term storage at Sellafield will be disposed of in the proposed
national repository.

4.27.2.10.               
Security measures

Security
requirements are based on IAEA source categories. Additional security measures
are also required including a security plan, ability to upgrade security for
increased threat, information security plan and personnel background checks.

4.27.3.                         
Detection
4.27.3.1.                   
Detection of orphan sources

In the UK the
threat is principally related to national security and counter-terrorism, and
the strategic locations for this are ports, airports and other access points.
This is a Government funded program. Detection equipment at UK borders is
managed by an agency of government. 
A secondary threat
relates to orphan sources in the metals recycling industry, here the threat is
managed by the companies involved and is a matter of commercial risk management
rather than national strategy. Metal industries are equipped with detection
equipment on a voluntary basis.

4.27.3.2.                   
Campaign for orphan sources recovery

There is no
regulatory framework for orphan source collection campaigns. Nevertheless, a
Government funded programme of subsidized disposal "Surplus Source
Disposal Programme" dealt with most of the UK's legacy of disused sources,
including a small number of orphan sources. The first campaign largely targeted
public sector organizations more than 11,000 surplus sources were collected and
disposed of at a cost of £7.14 million. The main difficulty during the campaign
was the availability of shielded facilities for sorting, conditioning and
packaging sources for long-term storage. Recycling/re-use would be the
preferred option, but it is seldom applicable to genuine orphan sources. 
Collection,
packaging, transport, recycling/disposal was achieved through specialist
private sector companies paid for by government funded subsidies and holder
contributions.
As sources held in
universities, hospitals and industries are considered under management and
regulatory control, a second recovery campaign is planned which will target
scrap yards. The objective is to retrieve orphan sources in use before the
transposition of the HASS Directive. 

4.27.3.3.                   
International cooperation and information
exchanges

UK participates in
the Incident and Trafficking Database of IAEA.

4.27.4.                         
Preparedness and Response
4.27.4.1.                   
Emergency plans and procedures

HASS holders must
prepare an emergency response plan which is reviewed at periodic inspections,
improvements may be required but there is no formal approval process. Such
emergency plan is not required for the facility where orphan sources are more
likely to be found.
For more than 30
years, the “National Arrangements for Incidents involving
Radioactivity” (NAIR) is invoked in relation to genuine orphan sources
found in public places or unauthorized premises. NAIR relies on nuclear site
and hospital radiation specialists to respond at the scene of an orphan source.
The NAIR has been triggered many times over the last 30 years for orphan
sources but there is no record of recent NAIR response to an incident involving
HASS. The NAIR scheme does not apply to Northern Ireland, but equivalent
arrangements are in place there.
The emergency
services often contact the relevant environment agency’s duty specialist
for advice which operates a 24/7 on call roster for such cases. 

4.27.4.2.                   
Training and information of persons potentially
confronted with an orphan source

Training and
information of personnel potentially confronted with an orphan source is not required
under UK environmental law, but may be considered necessary under the Health
& Safety at Work Act 1974, if a risk assessment identifies this to be a
foreseeable occupational risk. Scope of training, periodical review, categories
of personnel trained and organization of the training is specified by the
employer. Requirements vary.

5.                                         
Loss of HASS control incidents in Europe

Despite the control measures implemented under the Directive there have
been a few incidents in the European Union where control of a registered HASS
has been lost or an unregistered HASS has been found. Very few of these
(perhaps below ten) have involved harmful exposure and even fewer cases have
involved malicious intent. It is estimated that criminal incidents made up only
a minor percentage - less than 8 per cent - of all reported source incidents in
2007-2009.
From the data provided by the Member States, it can be concluded that
the 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. The second most frequent event reported by the
responding EU States is the discovery of orphan sources. Orphan sources have
been discovered at public places, municipal dumps and during the take-over of
facilities or on the premises of bankrupt companies. 

6.                                         
Development of HASS regulations in the EU
6.1.                                   
Directive
2003/122/EURATOM requirements as a part of the new EU Basic Safety Standards Directive 2013/59/EURATOM

The new EU Basic
Safety Standards Directive (BSS) [6] was adopted at the end of 2013. In
addition to updating the current BSS Directive [1] the new Directive
incorporates and updates requirements of five other existing Directives,
including the HASS Directive. It also takes into account the latest ICRP[2] guidance and the new International Basic
Safety Standards drafted by the IAEA. The old Directives have been repealed and
the EU Member States have four years to enact the new Directive in their
national legislations, i.e. until 6 February 2018.
There are
separate chapters on the control of sealed sources and on orphan sources in the
new Directive. These chapters include the current HASS Directive provisions,
with only a few significant modifications, outlined below.  

6.2.                                   
Regulatory
harmonisation with the IAEA

When the HASS
Directive was written the activity values defined for the IAEA regulations for the safe
transport of radioactive materials (A-values/100) [7] were selected as the
basis for the HASS definition. Later on the IAEA developed the D-values
(dangerous quantity of radioactive material) [4] and used them as a basis for
its source categorization system, which led to differing source definitions in
the HASS Directive and the IAEA Code of Conduct on the safety and security of
radioactive sources (CoC) [8]. The new EU BSS removes this discrepancy by
adopting the IAEA D-values as a basis for the HASS definition. This means that
Category 1, 2 and 3 sources are required to be controlled as HASS in the EU. 
The revision was
undertaken because several EU Member State authorities indicated that having
two different definitions at international level is a problematic situation.
The HASS Directive and the IAEA CoC on sources have similar aims, so they
should be applied on the same group of sources. Also in principle the IAEA and
the EU should seek harmonisation of international standards.
It was also felt
that, for many nuclides, the HASS Directive activity levels are quite low, so
not all HASS sources truly “imply considerable potential risks for
human health or environment”, as is stated in the Directive recitals,
whereas the scientific basis for D-values is sound and to a certain degree
supported by actual doses in real source accidents.
The
harmonisation means that the Member State authorities will have to adapt their
national limits accordingly. Moreover, since the D-values are mostly higher
than the HASS Directive (A1/100) values, the change means relaxing
the requirements for most nuclides (voluntary removal of some sources from the
HASS registers).
Table I presents
a comparison of the old and new HASS activity limits. For most nuclides the new
definition is indeed a relaxation of requirements, since the D-values are
higher than the HASS Directive values (ratio (A1/100)/D < 1).
However, in practice, most of the registered HASS sources have activities much
higher than the D-value so the group of sources falling between the old and new
definition (i.e. the sources which can be removed from the HASS registers after
transposition of the new BSS) is actually quite small.
For a few
nuclides the D-value is lower that the HASS Directive value (Am-241, Cm-244,
Pu-238 and Po-201). For these nuclides the activity level harmonisation means
stricter control requirements, although the differences between the old and new
values are hardly significant in practical operation of the HASS registers.   
 Nuclide || HASS-Directive || New BSS ||
 (A1-value/100) || (D-value) ||
 TBq || TBq || Ratio (A1/100)/D 
 Am-241 || 1.0E-01 || 6.0E-02 || 1.667 
 Cf-252 || 5.0E-04[3] || 2.0E-02 || 0.025 
 Cm-244 || 2.0E-01 || 5.0E-02 || 4.000 
 Co-60 || 4.0E-03 || 3.0E-02 || 0.133 
 Cs-137 || 2.0E-02 || 1.0E-01 || 0.200 
 Gd-153 || 1.0E-01 || 1.0E+00 || 0.100 
 I-125 || 2.0E-01 || 2.0E-01 || 1.000 
 Ir-192 || 1.0E-02 || 8.0E-02 || 0.125 
 Kr-85 || 1.0E-01 || 3.0E+01 || 0.003 
 Pm-147 || 4.0E-01 || 4.0E+01 || 0.010 
 Pu-238 || 1.0E-01 || 6.0E-02 || 1.667 
 Ra-226 || 2.0E-03 || 4.0E-02 || 0.050 
 Se-75 || 3.0E-02 || 2.0E-01 || 0.150 
 Sr-90 (Y-90) || 3.0E-03 || 1.0E+00 || 0.003 
 Tm-170 || 3.0E-02 || 2.0E+01 || 0.002 
 Yb-169 || 4.0E-02 || 3.0E-01 || 0.133 
 Au-198 || 1.0E-02 || 2.0E-01 || 0.050 
 Cd-109 || 3.0E-01 || 2.0E+01 || 0.015 
 Co-57 || 1.0E-01 || 7.0E-01 || 0.143 
 Fe-55 || 4.0E-01 || 8.0E+02 || 0.001 
 Ge-68 || 5.0E-03 || 7.0E-01 || 0.007 
 Ni-63 || 4.0E-01 || 6.0E+01 || 0.007 
 Pd-103 || 4.0E-01 || 9.0E+01 || 0.004 
 Po-210 || 4.0E-01 || 6.0E-02 || 6.667 
 Ru-106 || 2.0E-03 || 3.0E-01 || 0.007 
 Tl-204 || 1.0E-01 || 2.0E+01 || 0.005 

Table I. Numerical comparison of the activity limits of the HASS Directive and
the proposed new EU Basic Safety Standards
Another important change in the HASS definition is
that the definition now refers to current activity, not to the activity at the
time of manufacture or placing on the market. This means that when the source
activity has decayed below the D-value it can be removed from the HASS register
and no longer has to be controlled as HASS. 
It should be
noted that the Directive sets the minimum standard; EU Member States are free
to use more restrictive requirements in their national regulations.

6.3.                                   
Other changes

Other source
related changes introduced by the new EU BSS reflect the experience gained from
the application of the HASS Directive and the feedback from recent radioactive
source and contamination events. The most significant changes are the
following:   
·        
Definitions for sealed
sources and source containers have been slightly modified.
·        
There are new
requirements for metal contamination situations. A metal scrap recycling
installation is required to notify the competent authority if it suspects or
has knowledge of any melting or metallurgical processing of an orphan source.
It shall require that the contaminated materials are not used, placed on the
market or disposed of without the involvement of the competent authority. The
Member States shall encourage the establishment of systems to detect the
presence of radioactive contamination in metal products imported from third
countries, in places such as major metal importing installations and significant
nodal transit points.
·        
Member States are
required to ensure that the management of installations where orphan sources
are most likely to be found or processed, including large metal scrap yards and
major metal scrap recycling installations, and in significant nodal transit
points, are informed of the possibility that they may be confronted with a
source. If workers may be confronted with a source, they must be advised and
trained in the visual detection of sources and their containers, informed of
basic facts about ionising radiation and informed of and trained in the actions
to be taken on-site in the event of the detection or suspected detection of a
source.
·        
The HASS record sheet
included in the Directive Annex XIV has been improved by updating layout and terminology[4],[5]. This sheet
provides the information required for each HASS in the national register.
Optional information is marked with Italics.
·        
There are new general
requirements for unsealed sources. Member States shall ensure that arrangements
are made for keeping control of unsealed sources with regard to their location,
use and recycling or disposal. In addition the Member States shall require the
undertaking, as appropriate and to the extent possible, to keep records of
unsealed sources under its responsibility. Member States shall require each
undertaking holding an unsealed radioactive source to notify the competent
authority promptly of any loss, theft, significant spill or
unauthorised use or release.

7.                                         
Conclusions

HASS Directive
principles have been implemented well in the EU, although there are significant
differences in implementation practices among the EU Member States. The low
number of HASS-related inquiries to the Commission over the years indicates
that the Directive requirements are well understood and accepted. 
The authorities of the EU Member States recommend the following in
order to keep radioactive sources under control and to safely manage incidents: 
·        
systems for ensuring
traceability of radioactive sources throughout their life cycle,
·        
regular inspections,
·        
requirements of
physical protection in high-risk facilities,
·        
compulsory training of
the personnel,
·        
controls to detect
radioactive materials in strategic locations,
·        
exchange of information
among the national and international competent authorities,
·        
public information,
·        
testing of
pre-established plans for prevention of and response to incidents involving
HASS.
Directive
2003/122/Euratom is repealed, with effect from 6 February 2018, by the
Directive 2013/59/Euratom (the new Basic Safety Standards Directive), which
incorporates the main provisions of the Directive and harmonises them with the
IAEA guidance on radioactive sources. The new EU BSS Directive represents a
major revision of the whole EU radiation protection legal framework. Chapters
concerning HASS fit well in this framework, since the HASS Directive has been
well accepted by the EU Member States and there was no need for major
modifications in the HASS control, although the new BSS Directive corrects
several deficiencies of the HASS Directive. In particular, the achieved
harmonisation with the IAEA regulations places the EU Member States in a good
position to fulfil both EU and IAEA requirements on the control of high
activity sealed sources and orphan sources.
The EU Member
States have until 6 February 2018 to transpose the new BSS Directive into their
national legislation. The Commission encourages each Member State to take into
account the content of this review when redrafting the national regulations and
guidance on safety and security of radioactive sources.    
References
[1]        Council Directive 96/29/EURATOM
of 13 May 1996 laying down basic safety standards for the protection of the
health of workers and the general public against the dangers arising from
ionising radiation [EU Official Journal L 159 of 29.6.1996].
[2]        Council Directive
2003/122/EURATOM of 22 December 2003 on the control of high-activity sealed
radioactive sources and orphan sources [EU Official Journal L 346 of
31.12.2003].
[3]        Competent authorities referred
to in Council Directive 2003/122/EURATOM on the control of high-activity sealed
radioactive sources and orphan sources [EU Official Journal C 122/2 of
27.4.2013].
[4]        Dangerous quantities of
radioactive material (D values) (EPR-D-VALUES 2006), International Atomic
Energy Agency, 2006.
[5]        Communication from the
Commission to the European Parliament and the Council of 24 June 2009 on
Strengthening Chemical, Biological, Radiological and Nuclear Security in the
European Union – an EU CBRN Action Plan, 2009.
[6]        Council Directive
2013/59/Euratom of 5 December 2013 laying down basic safety standards for
protection against the dangers arising from exposure to ionising radiation, and
repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom
and 2003/122/Euratom [EU Official Journal L13/1 of 17.1.2014].
[7]        Regulations for the Safe
Transport of Radioactive Material, Safety Standards Series, Safety Requirements
No.TS-R-1, International Atomic Energy Agency, Vienna, 2009         
[8]        Code of Conduct on the Safety
and Security of Radioactive Sources, International Atomic Energy Agency,
Vienna, 2004
[1] Croatia was not a member of the EU during the review process and it
is not included in this report.
[2] International Commission on Radiological Protection
[3]       According to the 2009 revision of the Regulations for the
Safe Transport of Radioactive Material, No.TS-R-1, the A1- value of
Cf-252 is 1.0E-01 TBq, so the HASS Directive value should be 1.0E-03 TBq. 
[4]
      In accordance with Article 5 of the HASS Directive, the Commission has
made the standard record sheet available in electronic format (Excel and Pdf)
at
http://ec.europa.eu/energy/nuclear/radiation_protection/radioactive_sources_en.htm.
[5]       Section 'Special form certificate' has been replaced
with 'IAEA source category' and a new section on neutron sources has
been added.