Management of high-activity sealed sources in the European Union:
HASS Directive implementation status and legal developments
27-31 October 2013
Abu Dhabi, United Arab Emirates
International Conference on the Safety and Security of Radioactive Sources: Maintaining Continuous Global Control of Sources throughout Their Life Cycle
Grégory Delécaut & Vesa Tanner
European Union Council Directive 2003/122/EURATOM
Objectives
To prevent exposure of workers and the public from inadequate control of high-activity sealed sources, including orphan sources
To harmonise controls in place in the Member States
Definition of specific requirements ensuring that each HASS is kept under control, also when they become disused
HASS Directive transposition period ended 31.12.2005
High-activity sealed sources Directive entered into force on 31.12.2003
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About 50% of inventory represented by only 2 MS
70% of inventory represented by 4 MS
9 MS with inventory less than 100 HASS
~3,200 HASS holders in 24 MS
63% of HASS holders represented by only 4 MS
Between 1 and 40 HASS per holder in MS
But different way of counting
e.g. high activity irradiators: 1 source or several 100?
Need for uniform accountancy system?
About 30,700 HASS in 25 Members States (MS)
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Replies to questionnaire and reports by MS are main basis of analyses
Information was completed as far as possible through visits with Regulatory Authority
Real implementation in the field was not verified (no audits)
3 different types of results
OK: implemented according to HASS Directive requirements
Point of attention: implementation in general OK, but some particular point(s) of attention exist(s)
NOK: requirement of HASS Directive not implemented as such
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A review of the HASS Directive implementation was performed under the EU CBRN Action Plan
0 5 10 15 20 25
Regulatory authority
Legislative framework
Authorization for practice with HASS
Records keeping
National inventory
Inspections and penalties
Control of HASS by the holder
Sources holders’ training
Identification and marking of HASS
Transfers of HASS
Long-term management of disused HASS
Security measures
Detection of orphan sources
Campaigns for orphan sources recovery
International cooperation
Emergency plans & procedures
Training related to orphan sources
# OK # PoA # NOK
A good compliance is generally observed
Recovery campaigns for orphan sources (50% of MS)
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Only 1 requirement is poorly implemented
Art 9.4. MS shall ensure that campaigns are organised as appropriate, to recover orphan sources left behind from past activities”
Arguments forwarded by MS:
HASS under control
Inventory complete and up-to-date
Detection means at borders
No orphan sources yet discovered
No recognised storage facility available
Recovery campaign organised before HASS Directive transposition
Legislative framework (45% of MS)
Full Directive transposition still in preparation
Different activity levels used for HASS (category 3)
Implementation not according to HASS definition
Current activity versus activity at manufacturing time
Control of HASS by the holder (35% of MS)
No systematic leak tests by the source holders
Limited test programme by the source holders
only visual verification - no dose rate measurements - no leak tests
Identification and marking of HASS (35% of MS)
Documentation accompanying HASS not fully compliant with requirements
Existence of historical sources without ID number
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Several requirements show points of attention (1/2)
Long-term management of disused HASS (35% of MS)
HASS holders are not obliged to make adequate arrangements for long-term management of disused HASS during licensing
No maximal timeframe defined for storage of disused HASS at holder’s premise
Financial guarantee for long-term management of disused sources uncertain
Training and information of workers related to orphan sources (45% of MS)
No training of personnel potentially confronted with orphan sources
Not required by regulations
Not for all types of workers / installations
Training not documented nor repeated
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Several requirements show points of attention (2/2)
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Even if some requirements present points of attention on the European level , some Members States have implemented very
good practices regarding the different provisions of the HASS Directive
Several best practices were also identified (1/3)
Notification of records to authority
Maximal delay defined in regulation
Inspections
Safety and security issues inspected together
Security
Establishment of specific regulation
HASS holder’s training
Frequency: yearly training/ reminder for exposed workers
Programme defined / approved by the authority
Check of training records by authority/TSO during inspections
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Long-term management
A reasonable maximal period for storing disused sources at holder’s premises after which transfer becomes mandatory is set in regulation
Access to centralised storage facility with sufficient capacity
Financial arrangements such as monetary deposits by the holders / suppliers are made
Take-back provisions alone do not guarantee effective removal of disused sources from users’ premises
Detection means
Monitoring equipment regulatory imposed at strategic locations
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Several best practices were also identified (2/3)
Orphan sources
Organisation of campaign to recover legacy sources
Financial guarantee paid by the holders to cover intervention costs relating to the recovery of orphan sources
Training of persons potentially confronted to orphan sources
Obligatory according to regulations
For all categories of workers (management and workers)
For all types of installation at risk
Training regularly repeated, documented
Practical exercises
Response and alarming procedures where orphan sources are likely to be found
Procedures approved by the authority
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Several best practices were also identified (3/3)
Very limited information provided by Europol, Interpol and IAEA
Confidential information
Very few incidents (below 10) involving harmful exposure
Even fewer cases involving malicious intent
Criminal incidents less than 8% of all reported incidents in 2007-2009 (Interpol)
Discovery of radioactive sources or contaminated items in scrap metal is by far the most frequent incident
At scrap metal facilities but also at national borders
Discovery of orphan sources is second most frequent incident
Children playgrounds, public places, municipal dumps, take-over of facilities or in nearly bankrupt companies
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Loss of control incidents in Europe
European legislation is at least as well developed as US/Canadian legislation
Strong & weak points exist in each situation
Some good practices identified in US and Canada could advantageously be transposed at the European level Training assessed at the time of license application (USA/Canada)
Sealed Source Tracking System (USA/Canada)
Reports of inspection available for public review (USA)
Inspection priority code (USA)
Record of the most recent leak test results for transferee (Canada)
Regulatory document/guide related to security measures (Canada)
Security assessment performed by public institution (USA)
Some HASS Directive provisions could be implemented in USA and Canada to improve the control over high-risk sources
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Comparison of HASS requirements with the situation in USA and Canada
The new BSS was approved by the Council Atomic Questions Group on 29 May 2013 Directive contains six old directives
Full revision of the EU radiation protection law
Adoption of the new BSS will repeal the HASS Directive Date of adoption still unknown
Transposition period most likely three years from adoption
HASS Directive is one of the directives included in the new EU Basic Safety Standards (BSS)
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HASS activity limits are harmonised with the IAEA D-values
Current source activity is used in the HASS definition (not the activity at the time of manufacture)
Sources can be removed from the registers when they have decayed under the HASS activity limit
New (improved) HASS record sheet
New provisions concerning orphan source melting accidents
The new EU BSS include changes to the HASS regulations
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HASS source is defined as a source with activity equal or above a nuclide-specific activity level at the time of manufacture (placing on the market)
Activity level = IAEA A1-value / 100 A-value is a content limit to ensure that consequences of severe
damage to type A package are not unacceptable
Activity levels in the HASS Directive Annex 1 are based on the IAEA A1-values
HASS source is a source with minimum activity equal to one hundredth of the maximum activity allowed in type A transport package at the time of manufacture or placing on the market
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In the IAEA Code of Conduct for high-activity sealed sources the new D-values are used for defining a high-activity (dangerous) source
Basically the D-value is the smallest activity of all accident scenarios causing deterministic health effects, all exposure pathways and tissue types considered
The new EU BSS values correspond to the IAEA source category 3.
The new EU BSS harmonises the HASS definition by using the D-values
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The harmonisation in the new EU BSS has advantages
Having two different HASS definitions is a problematic situation Similar aims for HASS Directive and the IAEA CoC
Application to the same group of sources
Non-EU countries apply the D-values Current HASS activity levels are low, not all HASS sources truly
“imply considerable potential risks for human health or environment”.
In principle the IAEA and EU should seek harmonisation of international standards
Scientific basis for D-values is sound and supported by actual doses in real source accidents, whereas the current HASS level science is weaker (division factor 100 apparently is based on expert insight)
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… but raises some remarks
Some MS authorities have indicated that changing their current national limits would be problematic.
Since D-values are mostly higher than the A1/100 values the change means relaxing the requirements for most nuclides (voluntary removal of some sources from the HASS registers)
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Conclusions and recommendations
In general HASS Directive well implemented in MS
Practical implementation strongly variable among MS
Several MS do not organise recovery campaigns for orphan sources as they feel sources are under control
Re-evaluate the need for systematic recovery campaigns
Current definition of HASS seems to result in practical problems:
Use of activity at production results in some cases in significant efforts spent to lower risk sources, not in line with the graded approach principle
Current activity limits for HASS are not coherent with the IAEA source categorisation, resulting in difficulties with e.g. implementing CoC and international transport
The definition of HASS in new EU BSS is based on actual activity levels and activity limits are in line with the IAEA source classification
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The concept of “undue delay” for removal of disused sources from users’ premises is implemented in MS in very different ways
Define more precisely the term “undue delay”, e.g. max. 2 years
Financial guarantees for HASS & management of orphan sources is widely interpreted by MS
From pure contractual arrangements, over State guarantees to monetary deposits
Precise what are acceptable financial guarantees and to what extent “the money” has to be physically available
Training and information of personnel potentially confronted with orphan sources is currently imposed and verified by only a limited number of MS
Consider making the training obligatory and define the minimal content and frequency
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Conclusions and recommendations
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Thank you for your attention
- Gregory Delécaut: [email protected] - Vesa Tanner: [email protected]
Contacts: