Augustin Janssens EC DG ENER D4 1 Revision and consolidation of Euratom Basic Safety Standards European Commission DG Energy D4: Radiation Protection Augustin.

1Augustin Janssens EC DG ENER D4

Revision and consolidation of Euratom Basic Safety Standards

European Commission

DG Energy

D4: Radiation ProtectionAugustin Janssens


Overview• Revision and consolidation of BSS• Exposure situations• System of Protection• Existing exposure situations

– Radon (workplace, dwellings)– Building materials– Living in contaminated territory

• Planned exposure situations– Justification and regulatory control– Graded approach– Categories of exposure

• Emergency exposure situations– Emergency workers– Emergency planning and response

• public information

• Institutional infrastructure• Recast Directives• Transposition in national law


Revision and consolidationBSS DIRECTIVE

• Article 31 Group of Experts since 2005• Topical issues

– natural radiation sources– exemption, clearance, graded approach

• WP “Recast”– First consolidated draft text: meeting in June 2009 – Final text for Article 31 Experts in November 2009

• Approval of draft text and related Opinion – on 23-24.2. 2010

• Impact Assessment Report• Inter-Service consultation• Translation• Commission proposal to be adopted in September 2011

http://ec.europa.eu/energy/nuclear/radiation_protection/doc/art31/2010_02_24_draft_euratom_basic_safety_standards_directive.pdfhttp://ec.europa.eu/energy/nuclear/radiation_protection/doc/art31/2010_02_24_opinion_on_bss.pdf


Preparing revised and consolidated EU-BSS

• Commission Radiation Protection Unit in Luxembourg

• Article 31 Expert Group– WP BSS– WP Exemption and Clearance– WP Natural Sources– WP Graded Approach– WP MED– WP Recast

http://ec.europa.eu/energy/nuclear/radiation_protection/article_31_en.htm


RECASTBetter legislation - simplification

• Directives: – Basic Safety Standards (workers, general public): 1996– Patients/Medical Exposure Directive: 1997– Informing the public on measures in the event of a radiological

emergency: 1989– Outside Workers: 1990– High Activity Sealed Sources (HASS): 2003– (Radon Recommendation 90/143/Euratom)

• Recast:– In principle no discussion of unmodified text– In practice: too many changes with cross-cutting impact– Hence: “consolidation”


Revision of EU-BSS

• Consolidation of current Directives

• Allow for ICRP/IAEA– Exposure situations

• rather than processes: practices/interventions

– Incorporate natural radiation sources

• strengthen the requirements

– Protection of the environment


ICRP Publication 103Scope:

(176) … applied to all sources and all exposed individuals, in the following three exposure situations:

– planned: … involving the planned operation of sources (practices in operation)– existing: … that already exists when a decision on control has to be taken, including natural

background radiation …– emergency exposure situations

Principle of Justification:(206) … introduction of new activities where radiological protection is planned in advance and the necessary actions can be taken on the source(207) … where exposures can be controlled mainly by action to modify the pathways of exposure and not by action on the source

Problems:• “planned” associated with the applicable regime of regulatory control

– notification, registration and licensing of practices– any (industrial) activity for which an undertaking has legal responsibility for its conduct and

for the resulting exposure should be managed in the same way as practices• “existing” has been confounded with “practices that already exist”


Exposure situationsEuratom approach

• Planned: new source or new pathway of exposure resulting from the activity

• industries processing naturally occurring radioactive materials (NORM)

• operation of aircraft

• Existing: resulting from features of the location (not the type of activity)

• indoor Radon (ingress from soil) • commodities managed together with the exposure situation:

– building materials (gamma exposure, radon exhalation)– foodstuffs (post-accidental situation)

• Emergency: urgent situation• which can be planned or prepared for


Definitions

• Practice: any type of activity that involves the operation or introduction of radiation sources or which alters exposure pathways and is managed as a planned exposure situation

• Undertaking: a natural or legal person which has legal responsibility for carrying out a practice or who has legal responsibility for a radiation source– including the owner or holder of a source who does not conduct

related activities

• Occupational exposure: exposure of workers incurred in the course of their work – responsibility of the employer for (outside) workers and for

exposure to radon at work


Radiation Sources

Radioactive Material including

Radioactive Substances

Radiation Generators

Radioactive Waste Naturally occurring radioactive material

Radioactive Sources

Sealed Sources

High activity Sealed Sources

Orphan SourcesManagement of ra

diation sources

depends on the type of

exposure situatio

n


Options for structure:PLANNED EXPOSURE

SITUATIONSEMERGENCY EXPOSURE

SITUATIONSEXISTING EXPOSURE

SITUATIONS

Occupational exposure Occupational exposure Occupational exposure

Public exposure Public exposure Public exposure

Medical exposure

OCCUPATIONAL EXPOSURE

PUBLIC EXPOSURE MEDICAL EXPOSURE

Planned exposure situations Planned exposure situations Planned exposure situations

Emergency exposure situations


Existing exposure situations Existing exposure situations


Table of contents of revised EU-BSS

PreambleChapter I Subject Matter and ScopeChapter II DefinitionsChapter III System of ProtectionChapter IV Requirements for Education, Training and InformationChapter V Justification and Regulatory Control of practicesChapter VI Protection of Workers, Apprentices and StudentsChapter VII Protection of Patients and other Individuals

submitted to Medical ExposureChapter VIII Protection of Members of the PublicChapter IX Protection of the EnvironmentChapter X Requirements for Regulatory ControlChapter XI Final provisions


System of Protection Principles

• Justification of practices• Optimisation of protection

– constraints in planned exposure situations– reference levels in existing or emergency

situations– For medical exposure of patients: DRL’s

• Dose limits– effective dose (stochastic effects)– organ dose (tissue effects)


Reference levels• Bands of reference levels for public exposure and

corresponding societal criteria• RL in the range 20 mSv – 100 mSv for emergency

exposure situations– below 20 mSv if no disproportionate detriment or

excessive cost of countermeasures

• RL in the range 1 to 20 mSv per year for existing exposure situations– indoor radon exposure– long-term post-accidental management

• RL below 1 mSv for specific pathways of exposure


• Dose constraint– Prospective upper bound on individual dose– As an operational tool in cooperation between

employer (Outside Worker) and undertaking– For public exposure, to ensure compliance

with the dose limit

System of protection Optimisation

... where appropriate dose constraints may apply to organ doses (in terms of equivalent doses), as a precautionary measure to allow for uncertainties on health detriment below the threshold for deterministic effects


System of protectionDose limits

• Age limit for exposed workers (>18 y)

• Effective dose limit– 20 mSv in any single year– 5-years averaging may be authorised for certain

situations specified in national legislation

• Equivalent dose limit for the lens of the eye– Same as effective dose limit

Occupational exposure


• Effective dose limit– 1 mSv in any single year

• Equivalent dose limit for the lens of the eye– 15 mSv in any single year– 31-Expert Group June 2011: Keep provisionally

mainly for reasons of consistency with the Int.-BSS

Public exposure

System of protectionDose limits


Effective dose

• Sum of external and internal exposures– Committed effective dose

• Reference to definitions of ICRU and ICRP– Hp(d) (personal dose equivalent at depth d)

– wR and wT (organ and tissue weighting factors)

• Dose coefficients per unit intake– Inhalation, ingestion, workers, public (diff. ages)– Forthcoming consolidated publication by ICRP

• Under contract with EC: free public web access• IAEA: tables to be appended in CD Rom to printed version


Existing exposure situations

• Radon (workplace, dwellings)

• Building materials

• Living in contaminated territory


EC Recommendation on indoor exposure to radon (90/143/Euratom)

• Establish a system for reducing any exposure to indoor radon concentrations.

• Apply principle of optimisation.• Decisions should be made on annually-averaged

radon measurements • Develop criteria for identifying regions, sites and

building characteristics likely to cause high indoor radon levels

• Reference level for existing buildings– 400 Bq/m3

• Design level for construction of new buildings– 200 Bq/m3


Natural Radiation Sources in present BSS Directive 96/29/Euratom

• Exposure to radon in dwellings is not included in the scope

• Radon in workplaces– Addressed in Title VII (Natural Radiation Sources)

• Identification of “work activities” of concern

– Large flexibility for Member States on measures taken

• No specific requirements on building materials


New BSS: Radon action plan

• ”Member States shall establish an action plan to manage long term risks from radon exposures in dwellings, buildings with public access and workplaces for any source of radon ingress, whether from soil, building materials and water.”– Take into account issues specified in Annex XVI


• Assign responsibilities, allocate resources for measurements and remedial actions

• Criteria for delineation of radon prone areas• Criteria for identification of buildings of concern• Criteria for accreditation of measurement and

remediation services• Strategy for increasing public awareness in relation to

smoking• Long term goals for reducing lung cancer

Radon Action Planindicative list of issues in Annex XVI


Chapter VI Protection of workers Radon in workplaces

• Establishment of national reference level, – not exceeding 1000 Bq/m3

• Measurements necessary in – workplaces located at ground floor or at basement

level in radon prone areas – specific types of workplaces identified in action

plan• Principle of optimisation

– Reduce radon concentrations or exposures• If levels stay above reference level despite actions

– Manage as a planned exposure situation– Dose limit and requirements for occupational

exposure apply


Member States shall establish national reference levels for indoor annual average radon concentrations, not exceeding: – 200 Bq/m3 for new dwellings and new buildings

with public access– 300 Bq/m3 for existing dwellings– 300 Bq/m3 for existing buildings with public access

• In specific cases, allowing for occupancy time, a higher reference level with a maximum of 1000 Bq/m3

Chapter VIII Protection of the public Radon in dwellings


Chapter VIII Protection of the public Radon in dwellings

Member States shall:• identify dwellings above reference level and

encourage remedial action• ensure measurements in buildings with public

access in radon prone areas• establish building codes to prevent radon

ingress from soil and building materials• provide information (local and national) on

radon situation, risks and means for reducing radon concentrations


Building materials

• Reference level of 1 mSv per year– for indoor external exposure from building materials

• in excess of the background outdoor external exposure

• Below 1 mSv/y the material is exempted and free on the market in EU– above 1 mSv/y the national authority may consider appropriate

control measures• Information about the materials relevant for compliance

with building codes should be available before their placing on the market– activity concentration index– two categories (reflecting whether the material is used in bulk or

superficial quantities)– CEN/TC standards (construction products)


Building MaterialsIndustries processing residues and by-

products

Determine concentrations in listed types of building materials

Determine activity index I

Types of building materials identified by Regulatory Authority

Compliance with building codes

Classification of the materials

A BExempted

Types of building materials authorised by Regulatory

Authority

Architects

> Reference Level (1 mSv)


• VII: gives definition and use of the activity concentration index for the gamma radiation emitted by building materials

• IX: indicative list of types of building materials considered for control measures with regard to their emitted gamma radiation

• XVI: indicative list of items to be covered in the national action plans for radon in dwellings and workplaces

AnnexesExisting exposure situations


Contaminated areas• Delineation of affected regions• Consideration of the

– need and extent of protective measures– need to prevent or control access

• or impose restrictions on living conditions

• Assessment of exposures– means available to individuals for controlling their exposure

• In consultation with stakeholders:– Allow habitation and resumption of social and economic activities– Ongoing control of exposures– Establish living conditions that can be considered as normal,

including:• Reference level consistent with day-to-day life• Infrastructure to support self-help protective measures

– Information, advice, monitoring


Planned exposure situations

• Justification and regulatory control

• Graded approach

• Categories of exposure


Justification and regulatory control of planned exposure situations

• Identification of practices (two types)

• Justification:– 3 levels (type A)– 2 levels (type B)

• Authorisation, optimisation, dose constraints

• Informed consent (except law enforcement)– Routine security screening: alternative methods

Non-medical exposure of humans

Type A(Medical staff and equipment)

- Employment purposes

- Immigration purposes

- Insurance purposes

- Physical development and age

- Concealed object within the body

Type B

- Concealed objects on or attached to the body

- Concealed humans as part ofcargo-screening

- Other legal or security purposes



• Relevant information to competent authorities (Annex)

• Justification (Annex)

– Type approval / Consumer products

• Information of the competent authorities of other Member States

• European and international standards (IAEA/EU/NEA working group)

New type of apparatus or products



• Proportionality

• Effectiveness of regulatory control

Graded approach

Member States shall require any notified practice to be subject to regulatory control commensurate with the magnitude and likelihood of exposures resulting from the practice,



• Proportionality

• Effectiveness of regulatory control

Graded approach

Member States shall require any notified practice to be subject to regulatory control commensurate with the magnitude and likelihood of exposures resulting from the practice,

and commensurate with the extent by which regulatory control may have an impact on reducing such exposures or improving the safety of the installations


Regulatory Control - Graded Approach

Outside Scope of EU-BSS

Generic (explicit) Exemption

Specific Exemption

Registration

Licensing

Noti

fica

tion Authorization

Licensing:

- Nuclear fuel cycle

- Production of consumer goods

- High-activity sealed sources

- Worker exposure liable to exceed 6 mSv/y

- Discharge of significant amounts of airborneor liquid effluent to the environment

- .....


Regulatory Control - Graded Approach

Outside Scope of EU-BSS

Generic (explicit) Exemption

Specific Exemption

Registration

Licensing

Noti

fica

tion Authorization

Registration (or licensing):

- Administration of radioactive substances topersons

- Industrial radiography, accelerators

- Radiations generators or radioactive sourcesfor medical exposures

- Worker exposure liable to exceed 1 mSv/y

- .....


Release from regulatory control

• No general clearance levels in 1996 EU-BSS(Recommendations in RP 122)

• IAEA RS-G-1.7• Comparative Study

– IAEA levels used as both exemption andclearance levels in revised EU-BSS

• However, RS-G-1.7 does not apply to naturaloccurring radionuclides in two cases:

– Residues into building materials– Specific risk of groundwater contamination

Exemption and clearance


NORM residuesClearance criteria

drinking water standardsTID : 0.1 mSv

lower activity concen-trations

NORM materials

Regulated NORM INDUSTRY

< 300 µSv

Exempted industry

<1 Bq/g

practices involving artificial radionuclides

Nuclear fuel cycle

< 10 µSv

specific clearance

levels


Categories of exposure

• Occupational

• Medical

• Public

• Environment


Protection of workersAir and space crew

• Exposure of air crew– Requirements maintained– Regarded as planned exposure situation

• Exposure of space-crew– Included in scope of EU-BSS– Special authorised exposure


Protection of patients (Chapter VII)

• MED requirements essentially all maintained• New emphasis on

– Justification, e.g. for asymptomatic individuals– Information provided for patients– Diagnostic reference levels for Interventional

radiology procedures– Dose recording and reporting

• Dose indicating devices or features• Radiation dose in the report on the examination


Protection of patients (Chapter VII)

• New features– Detailed consideration of accidental or unintended exposures– The role of the quality assurance programme, including risk

analysis in radiotherapy, to avoid incidents – Strengthened involvement of the Medical Physics Expert in

radiological imaging examinations


Protection of members of the public

• Consumer goods (Chapter V)• Radioactive airborne or liquid effluent (Chapter

VIII)– Discharge authorisations shall

• Take account of the results of optimisation• Reflect good practice• Allow margin for operational flexibility

– Realistic assessment of doses• Representative person• Environmental monitoring• Record keeping• Information available to stakeholders


Protection of the Environment

• This Directive applies to the protection of the environment as a pathway from radiation sources to the exposure of man, complemented where appropriate with specific consideration of the exposure of biota in the environment as a whole.

• ICRP Publication 103– change in the paradigm– Publication 108: the concept and use of

reference animals and plants– principles of protection (2012?)


Protection of the EnvironmentChapter IX

• National legal framework– provision for protection of non-human species– environmental criteria

• populations of vulnerable or representative species• significance as part of the ecosystem

– identify practices for which regulatory control is warranted

• Authorised limits of discharges– generic screening assessment

• Technical measures to mitigate the environmental consequences of accidents

• Specific environmental monitoring


ICRP Guidance on the Protection of the Environment

• Publication 103 (2007): need for a scientific framework• Publication 108 (2008): “The concept and use of Reference Animals and

Plants”– Including an assessment methodology and – Derived Concentration Reference Levels (DCRL)

• Publication 1xx (2012): “The approach to protection of the environment under different exposure situations”

– Environmental Reference Levels for planned exposure situations• ERL < lower bound of DCRL• Starting point of optimisation of environmental exposures• No dose limits, compliance based solely on concentrations of radionuclides in the

environment (or rate of discharge)– Emergency exposure situations

• Severe effects: one or more orders of magnitude > DCRL• Limited options for mitigation• Impact on siting

– Existing exposure situations• DCRL starting point of optimisation of environmental exposures



• Emergency workers

• Emergency planning and response– protection of the environment– public information


Chapter VI: Emergency workers• Responsibility:

– Article 30.1(b): the (emergency response) organisation responsible for the protection of emergency workers

• Article 52: Emergency occupational exposure– Ensure that no emergency worker undertakes actions resulting in

doses in excess of 50 mSv• except in specific cases identified in the national emergency plan

– appropriate reference level above 50 mSv• In exceptional circumstances, …, a reference level above 100 mSv

may be set– Emergency workers liable to exceed 50 mSv are

• volunteers• clearly and comprehensively informed, in advance, of the associated

health risks and protection measures– In the event of an emergency exposure:

• radiological monitoring and medical surveillance• individual dose assessment as appropriate to the circumstances


Emergency planning and response• More comprehensive system:

– threat analysis– overall emergency management system– emergency response plans for identified threats

• reference levels– pre-planned strategies for the management of

each postulated event

• Compulsory cooperation between Member States– Member States shall (instead of …shall seek to)


AnnexesEmergency exposure situations

• IX.A: Elements to be included in an emergency management system

• IX.B: Elements to be included in an emergency response plan

• X.A: Prior information to the population likely to be affected by a radiological emergency

• X.B: Information to be provided to the affected population in case of a radiological emergency


Institutional infrastructure• Competent authority

– Communication to the Commission– Publication by the Commission

• Recognition of services and experts– Occupational health services– Dosimetry services– Radiation protection experts– Medical physics experts

– Specify the recognition requirements and communicate these to the Commission

• Radiation protection officer– Tasks within undertakings, necessary means, reporting directly to the

undertaking


Education, training and information

• Information and training of exposed workers, apprentices and students

• Information and training of workers potentially exposed to orphan sources

• Information and training of emergency workers

• Education, information and training in the fieldof medical exposure


Enforcement and Inspection

• Systematic inspection programme

• Findings available to the public

• Information to relevant parties of lessons learned from inspection and from incidents and accidents



• Basic Safety Standards (workers, general public): 1996– Natural radiation sources– Emergency exposure situations– Non-medical imaging– Graded approach to regulatory control– Protection of the environment

• Patients/Medical Exposure Directive: 1997• Informing the public on measures in the event of

a radiological emergency: 1989• Outside Workers: 1990• High Activity Sealed Sources (HASS): 2003



• Basic Safety Standards (workers, general public): 1996• Patients/Medical Exposure Directive: 1997

– Strengthened requirements• Informing the public on measures in the event of a

radiological emergency: 1989– In Annex

• Outside Workers: 1990– Responsibility of employer– Radiation Passbook and Dose Registry

• High Activity Sealed Sources (HASS): 2003– Annexes– Definition in Code of Conduct– Orphan sources, metal scrap


Transposition

• This Directive establishes the basic safety standards for the protection of the health of workers, general public, patients and other individuals subject to medical exposure against the dangers arising from ionising radiation for the purpose of their uniform implementation by Member States.

• Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 00.00.0000 at the latest. (2y?)

– The provisions laid down in Chapter X with regard to the protection of the environment shall be transposed by 00.00.0000. (4 y?)

Augustin Janssens EC DG ENER D4 1 Revision and consolidation of Euratom Basic Safety Standards European Commission DG Energy D4: Radiation Protection Augustin.

Documents

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ener d4

consolidation slide

energy d4

icrpiaea exposure situations

environment slide

euratom recast

revision of eu