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: gregory.delecaut@ire-elit.eu - Vesa Tanner: vesa.tanner@ec.europa.eu

Contacts: