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1 THE REGULATION OF RADIATION PROTECTION

1 1 The regulatory basis1 1 1 The international reference framework (ICRP, IAEA, Euratom)1 1 2 The Public Health Code and the Labour Code

1 2 Protection of individuals against the risks of ionising radiation from nuclear activities1 2 1 General protection of workers1 2 2 General protection of the population1 2 3 The licensing and declaration procedures for sources of ionising radiation1 2 4 Radioactive source management rules1 2 5 Protection of individuals during a radiological emergency1 2 6 Protection of the population in a long-term exposure situation

1 3 Protection of individuals exposed for medical and forensic purposes1 3 1 Justification of procedures1 3 2 Optimisation of exposure1 3 3 Forensic applications of ionising radiation

1 4 Protection of individuals exposed to technologically enhanced naturally occurringradioactive materials (TENORM)

1 4 1 Protection of individuals exposed to radon1 4 2 Other sources of exposure to TENORM

1 5 Radiological quality of water intended for human consumption and foodstuffs

2 BNI REGULATORY PROVISIONS

2 1 Authorisations and licences2 1 1 Siting2 1 2 Safety options2 1 3 Plant authorisation decrees2 1 4 Operating licences2 1 5 Final shutdown and decommissioning licences

2 2 General technical regulations2 2 1 Ministerial and government orders2 2 2 Documents produced by ASN2 2 3 French nuclear industry codes and standards

3 REGULATIONS FOR THE TRANSPORT OF RADIOACTIVE MATERIALS

3 1 International regulations

3 2 National regulations

4 OUTLOOK

APPENDIX 1 – VALUES AND UNITS USED IN RADIATION PROTECTION

APPENDIX 2 – REGULATION LIMITS AND DOSE LEVELS

2007 was marked by important decrees implementing the 2006-686 Act of 13 June 2006 concerning transparency and secu-rity in the nuclear field, known as the “TSN Act”.

Of the 15 decrees implementing the TSN Act, 9 were published during the course of 2007.

The BNI regime, dating from 1963, was thus completely overhauled with the entry into force of decree 2007-1557 of2 November 2007 concerning basic nuclear installations and the regulation of the nuclear safety aspects of the radioactivematerial transports.

As a result of this decree, ASN now has the legal tools it needs to play its full role as a regulatory body.

Apart from the complete overhaul of the BNI regime, the Public Health Code and the Labour Code also underwent signifi-cant changes, to take account of the requirements of European Council Directive 96/29/Euratom of 13 May 1996 settingbasic standards for the health protection of the population and workers against the risks of ionising radiation.

Two important small-scale nuclear activity and radiation protection decrees were adopted in 2007:– decree 2007-1582 of 7 November 2007 concerning the protection of individuals against the risks of ionising radiation andmodifying the Public Health Code, extensively revised Part III of Book III of the first part of the Public Health Code;

– decree 2007-1570 of 5 November 2007 concerning worker protection against ionising radiation and modifying the LabourCode.

This legislation is based on internationally adopted rules, whether regulations or community directives such as Councildirective 96/29/Euratom dated 13 May 1996 and setting basic standards for health protection of the population and workersagainst the risks of ionising radiation. It is also based on a variety of norms, standards and recommendations, such as therecommendations from the International Commission on Radiation Protection (ICRP) or the standards issued by theInternational Atomic Energy Agency (IAEA), in particular the International Basic Safety Standards for Protection againstIonising Radiation and for the Safety of Radiation Sources (Safety Series n° 115).

This chapter presents the current regulations applicable to radiation protection, nuclear safety and the transport of radioac-tive materials.

1 1 The regulatory basis

1 1 1 The international reference framework (ICRP,IAEA, Euratom)

The specific regulations for radiation protection are basedon various norms, standards and recommendations issuedinternationally by various organisations. The following inparticular should be mentioned:

– the International Commission on Radiation Protection(ICRP), a non-governmental organisation comprisingexperts in various fields from around the world. It pub-lishes recommendations concerning the protection ofworkers, the population and patients against ionisingradiation, based on an analysis of the available scientific

and technical knowledge. The latest recommendationsfrom the ICRP are to be found in ICRP Publication 60,which came out in 1991. The ICRP has completed revi-sion of this work and this in 2007 led to a new publica-tion taking account of changing professional knowledgeand experience;

– the International Atomic Energy Agency (IAEA) whichregularly publishes and revises standards in the fields ofnuclear safety and radiation protection. TheInternational Basic Safety Standards for Protectionagainst Ionising Radiation and for the Safety of RadiationSources (Safety Series n° 115), based on the ICRP recom-mendations, were published in 1996, in partnershipwith the United Nations Food and AgricultureOrganisation (FAO), the International LabourOrganisation (ILO), the OECD Nuclear Energy Agency

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(NEA), the Pan-American Health Organisation (PAHO)

and the World Health Organisation (WHO). IAEA has

begun a process to revise the International Basic

Standards for Protection against Radiation, while a new

standard concerning the basic safety principles was pub-

lished at the end of 2006;

– the International Standards Organisation (ISO) which

publishes international technical standards. These are a

key element in the radiation protection of individuals

and are the cornerstone between the principles, concepts

and units, and the body of regulatory texts for which

they guarantee harmonised implementation.

At a European level, the Euratom Treaty, and more particu-

larly articles 30 to 33, specifies how the standards for pro-

tection against radiation are drafted and defines the pow-

ers and obligations of the European Commission with

respect to how they are applied. The corresponding direc-

tives are binding on the various countries, such as direc-

tive 96/29/Euratom of 13 May 1996 setting basic standards

for health protection of the population and workers

against the risks of ionising radiation, directive

97/43/Euratom of 30 June 1997 concerning the health

protection of individuals against the risks of ionising radia-

tion during exposure for medical purposes, and directive

2003/122/Euratom of 22 December 2003 concerning

supervision of high-level sources and orphan sources. The

European Commission has initiated a revision of these

directives in order to take account of the experience

acquired by the member States and the changes made to

international texts.

1 1 2 The Public Health Code and the Labour Code

Since publication of Council directive 96/29/Euratomdated 13 May 1996 laying down basic safety standards forthe protection of the health of workers and the generalpublic against the risks arising from ionising radiation andCouncil directive 97/43/Euratom dated 30 June of 1997on health protection of individuals against the risks ofionising radiation in relation to medical exposure, a com-plete update has been undertaken of the legislative andregulatory provisions concerning radiation protectioncontained in the Public Health Code and the Labour Code.

The update of the legislative part was completed withpublication of the above-mentioned ordinance of28 March 2001 and Act 2004-806 of 9 August 2004concerning public health policy, with the introduction ofnew articles concerning the radiation protection inspecto-rate and an update to take account of the creation of ASN(Act of 13 June 2006).

Updating of the regulatory part is currently being comple-ted. The following were published in turn:

– decree 2001-1154 of 5 December 2001 concerningmandatory maintenance and quality control of medicaldevices;

– decree 2002-460 of 4 April 2002 concerning the protec-tion of individuals against the risks arising from ionisingradiation;

– decree 2003-270 of 24 March 2003 concerning the pro-tection of individuals exposed to ionising radiation formedical and forensic purposes (including forensic

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Assessment of scientific studies (UNSCEAR)

Discussions (ICRU, IAEA,OECD/NEA, WHO, etc.) Recommandations (ICPR)

International StandardsIAEA/ILO/WHO/PAHO/FAO/NET

Regional standardsEuropean directives

National legislation

Drafting of radiation protection policy

science, screening technologies, insurance and otherrelated applications);

– decree 2003-295 of 31 March 2003 concerning interven-tion in a radiological emergency and in the event oflong-term exposure;

– decree 2003-296 of 31 March 2003 concerning workerprotection against the risks of ionising radiation.

– decree 2006-694 of 13 June 2006 setting the proceduresfor designating, approving and swearing-in radiationprotection inspectors and modifying the Public HealthCode.

The decrees of 4 April 2002, 24 March 2003, 2003-295 of31 March and 2006-294 of 13 June 2006, mentionedabove, are codified in chapter 3 “Ionising Radiation” ofpart III of book III of the new regulatory part of the PublicHealth Code (art. R.1333-1 to R.1333-92). Decree 2003-296 of 31 March 2003 is codified in section 8 “Preventionof the risk of exposure to ionising radiation” in chapter I ofpart III of book II of the second part of the Labour Code.

The following overall architecture was adopted for upda-ting of this legislative and regulatory framework.

An initial update of chapter 3 “Ionising Radiation” of thePublic Health Code, was carried out in 2005, with addi-tions to section 7 “Emergency situations and long-termexposure” by decree 2005-1179 of 13 September 2005concerning radiological emergencies, in order to complete

the transposition of Council directive 89/618/Euratom of27 November 1989 concerning public information aboutapplicable heath protection measures and what to do inthe event of a radiological emergency.

A second update was carried out in 2007 (decree 2007-1582 of 7 November 2007 concerning protection of indi-viduals against the risks arising from ionising radiationand modifying the Public Health Code and decree 2007-1570 of 5 November 2007 concerning worker protectionagainst the risks arising from ionising radiation and modi-fying the Labour Code) in order to meet the followingobjectives:– to transpose Council directive 2003/122/Euratom of22 December 2003 on the control of high-level sealedradioactive sources and orphan sources;

– to introduce administrative simplification measures, par-ticularly with regard to the ionising radiation sourcelicensing and notification procedures, incorporating theexperience acquired in application of the new regula-tions;

– to supplement requirements concerning regulation ofradiation protection;

– to take account of the prerogatives granted to ASN bythe Act of 13 June 2006.

The actual implementation of the new regulatory require-ments was dependent on the publication of a number oforders (27 were published between July 2003 and

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Legislative partof the Labour Code(Articles L.12-37-1 and 2)

Transposition of directives 96/29, 97/43 and 2003/122 Euratom

Legislative part of the PublicHealth Code

(Articles L.1333-1 to 20 and L.1336-5 to 9)

Regulatory part

- Scope and principles of radiationprotection- Technical rules for outfitting of workingpremises- Rules applicable to workers exposed toionising radiation- Medical supervision of exposed workers- Rules concerning abnormal workingsituations- Functional organisation of radiationprotections- Rules applicable to professionalexposure to NORM

Lab

ou

rC

od

e

Pu

blic

Hea

lth

Co

de

PublicH

ealth

CodeLabour Code

Section 1General mesures

to protect the population

Section 2Exposure to ionising

radiation

Section 3General licensing and

notification system

Section 5Patients protection

Section 6Emergency situations and long term exposure

Section 7Supervision

Section 4Management of radioactive

sources

Regulatory part, chapter III “Ionising radiation”of part III of book III of the first

part of the Public Health Code(new regulatory part)

Legislative and regulatory architecture of radiation protection

September 2006, 8 are still to be published) and a largenumber of ASN technical decisions (42 decisions are men-tioned in the Public Health Code and the Labour Code).However, transposition of the above-mentioned directives96/29/Euratom, 97/43/Euratom and 89/618/Euratom isconsidered to be complete.

The Public Health Code

The principles of radiation protectionChapter III “Ionising Radiation” of part III of book III ofthe legislative part of the Public Health Code aims to coverall “nuclear activities”, that is all activities involving a riskof human exposure to ionising radiation, emanating eitherfrom an artificial source, whether a material or a device, orfrom a natural source when the natural radionuclides areor have been treated owing to their fissile or fertileradioactive properties. It also includes “interventions”aimed at preventing or mitigating a radiological hazard fol-lowing an accident, due to environmental contamination.

The general principles of radiation protection (justifica-tion, optimisation, limitation), established internationally(ICRP) and incorporated in the above-mentioned directive96/29/Euratom, are enshrined in the Public Health Code(article L. 1333-1). They constitute guidelines for the regu-latory action for which ASN is responsible.

1. The principle of justification“A nuclear activity or intervention may only be undertakenor carried out if justified by the advantages it procures,particularly in health, social, economic or scientific terms,with respect to the risks inherent in the exposure toionising radiation to which the individuals are likely to besubjected.”

Depending on the type of activity, the justification decisionlies with various levels of authority: it lies with theGovernment for issues of general interest, as in the case ofwhether or not to resort to nuclear energy; it lies with ASNin the case of sources used for medical, industrial andresearch purposes; it lies with the AFSSAPS for release tothe market of a new irradiating medical device and withthe physicians for prescribing and carrying out a diagnos-tic or therapeutic procedure. Assessment of the expectedbenefit of a nuclear activity and the corresponding healthdrawbacks may lead to prohibition of an activity for whichthe benefit would not seem to outweigh the risk. This pro-hibition is either generic (for example: ban on the inten-tional addition of radioactive materials in consumergoods), or the licence required with regard to radiationprotection will be refused or will not be renewed. Forexisting activities, justification may be reassessed if currentknow-how and technology so warrants.

2. The principle of optimisation“Human exposure to ionising radiation as a result of anuclear activity or medical procedure must be kept as lowas reasonably achievable, given the current technological,economic and social factors and, as applicable, the medicalpurpose involved”.

This principle, referred to as the ALARA principle, forexample leads to a reduction in the discharge licences ofthe quantities of radionuclides present in the radioactiveeffluents from nuclear installations, to surveillance ofexposure at the workstation in order to reduce it to thestrict minimum, and to ensure that medical exposure as aresult of diagnostic procedures remains close to the pre-determined reference levels.

3. The principle of limitation“Exposure of a person to ionising radiation as a result ofa nuclear activity, cannot raise the sum of the dosesreceived beyond limits set by the regulations, unless thisperson is exposed for medical purposes or for biomedicalresearch.”

The exposure of the general population or of workers as aresult of nuclear activities is subject to strict limits. Theselimits comprise significant safety margins to prevent theappearance of deterministic effects. They are also far belowthe doses at which probabilistic effects (cancers) havebegun to be observed (100 to 200 mSv). Exceeding theselimits is considered to be unacceptable and in France, canlead to administrative or legal sanctions.

In the case of medical exposure, no strict dose limit isestablished in that this voluntary exposure is justified bythe anticipated health benefits to the person exposed.

The notification and licensing systemThe new legislative base introduced into the Public HealthCode means that decrees of the Conseil d’Etat* can be usedto lay down general rules concerning the conditions forprohibition, licensing and notification of uses of ionisingradiation (art. L. 1333-2 and 4), as well as rules for artifi-cial or natural radionuclides management (art. L. 1333-6to L. 1333-9). These licences and notifications concern allapplications of ionising radiation generated by radionu-clides or by electrical X-ray generators, whether for medi-cal, industrial or research purposes.

Exposure to Technologically Enhanced NaturallyOccurring Radioactive Materials (TENORM)The transposition of above-mentioned directive96/29/Euratom also led to new provisions being defined toassess and reduce exposure to naturally-occurring radioac-tive materials (NORM), in particular exposure to radon,

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*France’s highest administrative court.

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when human activities contribute to enhancing this expo-sure (article L. 1333- 10 of the Public Health Code).

Inspection of radiation protection

In 2004, new provisions were introduced, creating the newradiation protection inspectorate (art. L. 1333-17 toL. 1333-19), oversight of which is entrusted to ASN. Theimplementing decree of 13 June 2006 set the proceduresfor designating, approving and swearing-in the radiationprotection inspectors. The law of 13 June 2006 now givesthe ASN Chairman the powers to designate radiation pro-tection inspectors, chosen mainly from among ASN per-sonnel. The administrative and judicial police powers ofthe radiation protection inspectors were also defined (art.L. 1337-1-1).

Finally, a new system of legal sanctions accompanies theseprovisions (articles L. 1337-5 to L. 1337-9).

The Labour CodeThe new provisions of the Labour Code (articles L. 230-7-1 and L. 230-7-2) introduce a legislative base specific tothe protection of workers, whether or not salariedemployees, with a view to transposition of Council directi-ve 90/641/Euratom of 4 December 1990 on the operatio-nal protection of outside workers exposed to the risk ofionising radiation during their activities in controlled areasand the above-mentioned Council directive96/29/Euratom. They also bring French legislation intoline with directive 90/641/Euratom concerning non-sala-ried workers exposed to ionising radiation.

A link with the three radiation protection principles in thePublic Health Code is established in the Labour Code, andthe rules concerning worker protection are the subject of aspecific decree (decree 2003-296 of 31 March 2003).

1 2 Protection of individuals against the risks ofionising radiation from nuclear activities

1 2 1 General protection of workers

Articles R. 231-71 to R. 231-116 of the Labour Code, intro-duced by above-mentioned decree 2003-296 of 31 March2003, create a single radiation protection system for allworkers (whether or not salaried) likely to be exposed toionising radiation during their professional activities. Ofthese requirements, the following should be mentioned:– application of the optimisation principle to the equipment,processes and work organisation (art. R. 231-75), whichwill lead to clarification of where responsibilities lie andhow information is circulated between the head of thefacility, the employer, in particular when he or she is notthe head of the facility, and the person with competence forradiation protection;

– the dose limits (art. R. 231-76) were reduced to 20 mSv for12 consecutive months, barring waivers resulting fromexceptional exposure levels justified in advance, or emer-gency occupational exposure levels;

– the dose limits for pregnant women (art. R. 231-77) ormore accurately for the child to be born (1 mSv for theperiod from the declaration of pregnancy up until birth).

The publication of implementing orders offers the clarifica-tion necessary for these new measures to be put into place.

ZoningNew provisions concerning the boundaries of monitoredzones, controlled zones and specially regulated zones (sub-ject to special checks) were issued, regardless of the activitysector, by the order of 15 May 2006 (O.G. of 15 June 2006).This order also defines the health, safety and maintenance

Signs marking out areas in which work with ionising radiation is carried out

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rules to be observed in these zones. When marking out theregulated zones, three levels of protection are now taken intoaccount. They are the effective dose for external and, asapplicable, internal exposure of the whole organism, theequivalent doses for external exposure of the extremities and,as applicable, the dose rates for the whole organism. Theorder thus sets reference values that the head of the esta-blishment is required to compare with the external andinternal exposure levels encountered at the workstations,when determining the zones. A DGT/ASN circular of18 January 2008 specifies the implementation procedures.

The person with competence for radiation protection(PCR)

The duties of the person with competence for radiation pro-tection (PCR) were extended to marking out the areas inwhich radiation work is being carried out, to assessing theexposed workstations and to taking measures such as toreduce exposure (optimisation). For the performance ofthese duties, the PCR will have access to passive and activedosimetry data (art. R. 231-106). The PCR must receive theirtraining from instructors accredited by the COFRAC.

The 26 October 2005 order concerning training of the per-son with competence for radiation protection and certifica-tion of the instructor, distinguishes between three differentactivity sectors:

– the “medical” sector, comprising nuclear and radiologicalactivities intended for preventive and curative medicine -including forensic examinations - dentistry, medical biolo-gy and biomedical research, as well as veterinary medicine;

– the “BNI - ICPE” sector, covering establishments contai-ning one or more basic nuclear installations and thosewhich comprise an installation subject to licensing as aclassified facility, with the exception of the nuclear activi-ties in the medical sector defined above;

– the “industry and research” sector, covering the nuclearactivities defined in article R. 231-73 of the Labour Code,with the exception of the activities in the “medical” and“BNI - ICPE” sectors defined above.

Training comprises a theory module - common to all theoptions - and a practical module specific to each sector, com-prising two options (“sealed sources and electric generatorsof ionising radiation” and “unsealed sources”). The durationand content of the PCR training programme therefore differaccording to the activity sector in which the person is towork and the type of sources used.

Dosimetry

The new arrangements for accreditation of organisationsresponsible for worker dosimetry have also been published(order of 6 December 2003); the arrangements for workermedical surveillance and transmission of information onindividual dosimetry were published in the order of30 December 2004. ASN is now in charge of examining the

accreditation applications submitted by the dosimetry orga-nisations and laboratories.

Radiation protection supervision

Technical supervision of sources and devices emitting ioni-sing radiation, protection and alarm devices and measuringinstruments, as well as ambient environment checks, can beentrusted to the French Institute for Radiation Protectionand Radiation Safety (IRSN), to the department with compe-tence for radiation protection or to organisations approvedunder application of article R. 1333-44 62 of the PublicHealth Code. The supervision procedures were published inthe order of 26 October 2005.

In application of articles R. 231-84 of the Labour Code andR. 1333-44 of the Public Health Code, this order defines thetype and frequency of radiation protection technical supervi-sion inspections. These concern sources and devices emittingionising radiation, the ambient environment, measuringinstruments and protection and alarm devices, managementof sources and of any waste and effluents produced. Thissupervision is partly carried out as part of the licensee’s in-house inspection processes and partly by outside organisa-tions (the outside checks must be performed by IRSN or anorganisation approved under article R. 1333-44 of the PublicHealth Code). The approval procedures for these organisa-tions were defined in the order of 9 January 2004. ASN isnow responsible for examining accreditation applicationssubmitted by the organisations.

The list of accredited organisations is available from the ASNwebsite, www.asn.fr.

Radon in the workplace (see point 141).

1 2 2 General protection of the population

Apart from the special radiation protection measuresincluded in individual nuclear activity licences for thebenefit of the population as a whole and the workers, anumber of general measures included in the Public HealthCode help to protect the public against the risks of ioni-sing radiation.

The intentional addition of natural or artificial radionu-clides in all consumer goods and construction materials isprohibited (art. R. 1333-2 of the Public Health Code).Waivers may however be granted by the Minister forHealth after receiving the opinion of the French HighPublic Health Council, except with respect to foodstuffsand materials placed in contact with them, cosmetic pro-ducts, toys and personal ornaments. This new range ofprohibitions does not concern the radionuclides naturallypresent in the initial components or in the additives usedto prepare foodstuffs (for example potassium 40 in milk)

or to manufacture materials used in the production of con-sumer goods or construction materials.

Furthermore, the use of materials or waste from a nuclearactivity is also in principle prohibited, when they are con-taminated or likely to have been contaminated by radionu-clides as a result of this activity.

The annual effective dose limit (article R. 1333-8 of thePublic Health Code) received by a member of the public asa result of nuclear activities, is set at 1mSv; the equivalentdose limits for the lens of the eye and the skin are set at15 mSv/year and 50 mSv/year respectively (average valuefor any 1 cm surface of skin). The calculation method forthe effective and equivalent dose rates and the methodsused to estimate the dosimetric impact on a population aredefined by ministerial order of 1 September 2003.

A national network for collection of environmentalradioactivity measurements is currently being set up (art.R. 1333-11 of the Public Health Code) and the data col-lected will help estimate the doses received by the popula-tion. This network collates the results of the various envi-ronmental impact assessments required by the regulations,and those of analyses performed by the various govern-ment departments and its public institutions, by localauthorities and by associations who so request. Theseresults will be made available to the public. Managementof this monitoring network has been entrusted to IRSN,with guidelines being defined by ASN (order of 27 June2005 organising the national network for environmentalradioactivity measurements and setting the procedures forlaboratory accreditation).

So that the quality of the measurements taken can be gua-ranteed, the laboratories in this network must meetapproval criteria, which in particular include intercompa-rison benchmarking tests. The list of accredited organisa-tions is available from the ASN website, www.asn.fr.

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Old advertising poster for the now prohibited uses of radionuclides in consumer goods

Old advertising poster for agricultural fertiliser containing radium

Management of waste and effluents from BNIs and ICPEsis -subject to the provisions of the special arrangementsconcerning these installations (see point 2 of this chapter).For management of waste and effluents from other facili-ties, including hospitals (art R. 1333-12 of the PublicHealth Code), general rules will be specified by an ASNdecision. This waste and effluents must be disposed of induly authorised facilities, unless there are special provi-sions for on-site organisation and monitoring of theirradioactive decay (this concerns radionuclides with aradioactive half-life of less than 100 days).

Although above-mentioned directive 96/29/Euratom soallows, French regulations have not adopted the notion ofdischarge threshold, in other words the generic level ofradioactivity below which the effluents and waste from anuclear activity can be disposed of without supervision. Inpractice, waste and effluents disposal is monitored on acase by case basis when the activities which generate themare subject to licensing (as is the case of BNIs and installa-tions classified on environmental protection grounds). Theregulations also do not include the notion of “trivial dose”,in other words the dose below which no radiation protec-tion action is felt to be necessary. This notion appearshowever in above-mentioned directive 96/29/Euratom(10 microsievert/year).

1 2 3 The licensing and declaration procedures forsources of ionising radiation

The system of licensing or notification, which covers allsources of ionising radiation, is described in full in section3 of chapter III of part III of book III of the Public HealthCode. This section was updated in 2007 to take account ofthe experience acquired by ASN since 2002 and the newprerogatives granted to it by the 13 June 2006 Act.

All licences will from now on be issued by ASN and notifi-cations will be filed with ASN regional departments.

All medical, industrial and research applications are con-cerned by these measures. This more specifically concernsthe manufacture, possession, distribution - includingimport and export, and use of radionuclides or productsand devices containing them.

The licensing system applies irrespectively to companies orfacilities which have radionuclides on-site, as well as tothose which trade in them without directly possessingthem. This is in conformity with directive 96/29/Euratomwhich explicitly mentions both import and export. Fromthe public health and safety viewpoint, this obligation isessential to close monitoring of source movements and tothe prevention of accidents as a result of orphan sources.

In accordance with article L.1333-4 of the Public HealthCode, the licences concerning industries covered by theMining Code, BNIs and ICPEs, constitute radiation protec-tion authorisations. The list of installations classified onenvironmental protection grounds concerning certainnuclear installations was modified by decree 2006-1454 of24 November 2006. Facilities other than industrial andcommercial facilities (health institutions for example) areno longer included on this list and that for industrial acti-vities, the classification as an ICPE only becomes mandato-ry if the facility which uses the radioactive source issubject to licensing under one of the headings of the list.

The procedures for submitting licensing applications ornotifications, specified by the order of 14 May 2004, willneed to be updated by ASN in order to introduce the con-tent of the files enclosed with the licensing application andthe submission of notification, along with the content ofthe licences.

The medical, biomedical research and forensic fields

For medical and biomedical research applications, thelicensing system contains no exemptions:

– the licences required for the use manufacture of radionu-clides, or products and devices containing them, as wellas for their distribution, import or export, are issued byASN and no longer by the French Health Products SafetyAgency (AFSSAPS);

– the licences required for the use of radionuclides, pro-ducts or devices containing them, are issued at a nationallevel by ASN;

– ASN must be notified of X-ray generators if they are oflow-intensity (radiology or dental surgery). Larger scaleequipment (scanners) requires a licence issued by ASN.

X-ray installations used for forensic procedures are subjectto a system of licensing or notification applicable to medi-cal installations, whenever their operation involves expo-sing individuals to ionising radiation.

Furthermore, in order to be able to carry out biomedicalresearch, the “researcher” must have prior authorisationfrom the place of research (L.1121-13) in the followinghighly particular cases:

– when this is not a place of health care;

– when this is a place of health care but:

• the research involves the performance of proceduresnot usual in this place,

• the person being treated has a clinical condition otherthan that for which the department is competent.

Chapter III “Ionising radiation” (part III, book III) of thePublic Health Code was modified in order to transposeCouncil directive 2003/122/Euratom of 22 December2003 concerning the supervision of high-level sealed

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An ASN decision will define the procedures for implementation of the measures concerning the identification and markingof high-level sealed sources, as well as the type of information concerning these sources that the person in possession will berequired to provide.A new requirement is introduced for the control of orpphan radioactive sources: the préfet* is asked to determine how theyare to be dealt with as well as the steps to be taken in the event of such a source being discovered.*In a département, representative of the State appointed by the President.

radioactive sources and orphan sources, which are definedin appendix 13-7.

The industrial and non-medical research fieldsASN is also in charge of issuing licences for non-medicalindustrial and research applications, and for receiving thenotifications. For these areas, this concerns:– the import, export and distribution of radionuclides andproducts or devices containing them;

– the manufacture of radionuclides, products or devicescontaining them, the use of devices emitting X-rays or ofradioactive sources, the use of accelerators other thanelectron microscopes and the irradiation of products ofwhatsoever nature, including foodstuffs, with the excep-tion of activities which are licensed under the terms of theMining Code, the BNI system or that applicable to ICPEs.

The criteria for licensing exemption adopted by directive96/29/Euratom (Appendix 1, table A) have been intro-duced into and appended to the Public Health Code (tableA, appendix 13-8) and values for supplementary radionu-clides introduced by the order of 2 December 2003 havebeen added to it.

Exemption will be possible if one of the following condi-tions is met:– the total quantity of radionuclides possessed is less thanthe exemption values in Bq;

– the radionuclide concentrations are less than the exemp-tion values in Bq/kg.

For this latter criterion, a mass limitation was introduced(the mass of material used must be less than 1 ton), whichis the reference criterion used when preparing the scena-rios on which the exemption values were based. The trans-position into French law is thus stricter than Directive96/29/Euratom which does not introduce this mass limit.Introduction of this restrictive criterion should avoid therisk of the radioactive material being diluted in order tofall below the exemption threshold.

Transport of radioactive materialsWithout prejudice to the regulations concerning the trans-port of dangerous goods, companies that transportradioactive materials must now submit a notification to orrequest a licence from ASN for all transports within thenational territory.

Technical supervision of radiation protection

Technical supervision of the radiation protection organisa-tion, including supervision of the management of radioac-tive sources and any associated waste, is entrusted toapproved organisations (R. 1333-44 of the Public HealthCode). The list of approved organisations is available fromthe ASN website, www.asn.fr. The type and frequency ofthe inspections were defined by the order of 26 October2005, mentioned in point 121.

1 2 4 Radioactive source management rules

The general radioactive source management rules are con-tained in section 4 of chapter III of part III of book III ofthe Public Health Code. They were drafted on the basis ofrules laid down by the CIREA (Interministerial commis-sion on artificial radioelements) and their supervision isnow the responsibility of ASN. However, the CIREAradioactive source inventory duties have been transferredto IRSN (article L.1333-9 of the Public Health Code).These general rules are as follows:

– sources may only be transferred to or acquired fromsomeone in possession of a licence;

– prior registration with IRSN is mandatory for the acqui-sition, distribution, import and export of radionuclidesin the form of sealed or unsealed sources, or products ordevices containing them. This prior registration isnecessary so that monitoring of the sources and controlby the customs services can be organised;

– traceability of radionuclides in the form of sealed orunsealed sources, or products or devices containingthem, is required in each institution, and a quarterlyrecord of deliveries must be sent to IRSN by the suppli-ers;

– any loss or theft of radioactive sources must be notified;

– validity of the formalities required for the import andexport of radioactive sources, products or devices,defined by the CIREA and the customs services, isrenewed.

The system for disposal and recovery of sealed sourceswhich have either expired or reached the end of theiroperational life, is taken from the CIREA special licensingconditions (decision of the 150th CIREA meeting of23 October 1989):

96

– all users of sealed sources are required to recoversources that have expired, are damaged, or have reachedthe end of their operational life, at their own expense(except when a waiver is granted for decay in-situ);

– simply at the request of the user, the supplier isrequired unconditionally to recover any source nolonger needed or which has expired.

The conditions for the use of gamma radiography deviceswere updated by the order of 2 March 2004, therebyabrogating the special conditions which had been stipula-ted by CIREA.

The methods for calculating the financial guaranteesrequired from source suppliers will shortly be introducedinto the Public Health Code. The national table ofcharges, established for each family of sources, will bespecified by order of the ministers responsible for healthand finance, on recommendations from ASN, IRSN andANDRA, along with the procedures for implementaionand payment of this guarantee.

1 2 5 Protection of individuals during a radiologicalemergency

The population is protected against the risks of ionisingradiation in the event of an accident or of radiologicalemergency situations through the implementation ofspecific actions (or countermeasures) appropriate to thenature and scale of the exposure. In the particular caseof nuclear accidents, these actions were defined in thegovernment circular of 10 March 2000 which amendedthe off-site emergency plans applicable to basic nuclear

installations, by expressing response levels in terms ofdoses. These levels constitute reference points for thepublic authorities (préfets) who have to decide locally, ona case by case basis, on what action is to be taken. Theseactions are:

– sheltering, if the predicted effective dose exceeds10 mSv;

– evacuation, if the predicted effective dose exceeds50 mSv;

– administration of stable iodine, when the predictedthyroid dose is liable to exceed 100 mSv.

These response levels were included in the order of13 October 2003 concerning response levels in a radio-logical emergency situation, implementing articleR. 1333-80 of the Public Health Code. The referenceexposure levels for individuals intervening in a radiolog-ical emergency situation are also defined in the regula-tions (article R. 1333-86 of the Public Health Code) andtwo groups of response personnel are thus defined:

– the first group comprises the personnel making up thespecial technical or medical response teams set up todeal with a radiological emergency.

These personnel benefit from radiological surveillance,a medical aptitude check-up, special training andequipment appropriate to the nature of the radiologicalrisk;

– the second group comprises personnel who are notmembers of the special response teams but who arecalled in on the basis of their expertise. They are givenappropriate information.

The reference individual exposure levels for the partici-pants, expressed in terms of effective dose, should be setas follows:

Section 3 of chapter III (part III, book III) of the Public Health Code concerning the general system of licensing and notifi-cation has been completely reorganised and supplemented, in order to simplify the licensing and notification system set upin 2002 and include ASN’s new prerogatives with regard to individual decisions.

The main changes made involve many sources being transferred from the licensing to the notification category, cancellationof the 5-year licence validity period, it now being possible for ASN to set such a limit on a case by case basis if necessary, butwith a maximum of 10 years, and the possibility of issuing the individual licence to a corporate body rather than an indivi-dual person. For implementation of this section, several ASN decisions will be required, in particular to:– exempt certain electrical devices from licensing or notification, as their design confers effective protection;– draw up the list of installations subject to notification;– clarify the list of the information to be included with the notification and the licensing application;– indicate the elements which can be covered by the licence issued by ASN;– set the particular conditions for use of certain ionising radiation sources;– lay down minimum technical rules for the design, operation and maintenance of the installations.

– the effective dose which may be received by personnelin group 1 is 100 mSv. It is set at 300 millisievertswhen the intervention measure is aimed at protectingother people;

– the effective dose which may be received by personnelin group 2 is 10 millisieverts. In exceptional cir-cumstances, volunteers informed of the risks involvedin their acts may exceed the reference levels, in orderto save human life.

Public information in a radiological emergency

The ways in which the population is informed in a radi-ological emergency situation are covered by a specificdirective (directive 89/618/Euratom of 27 November1989 concerning public information about health pro-tection measures and how to act in the event of a radio-logical emergency). This directive was transposed intoFrench law by:

– decree 2001-470 of 28 May 2001 concerning publicinformation and modifying decree 88-622 of 6 May1988 dealing with emergency plans and two imple-menting orders (order of 30 November 2001 concer-ning the creation of an emergency alert system arounda basic nuclear installation with its own off-site emer-gency plan (PPI) and the order of 21 February 2002concerning information of the populations);

– decree 2005-1179 of 13 September 2005 concerningradiological emergency situations.

Two implementing orders were published:

– the order of 4 November 2005 concerning publicinformation in the event of a radiological emergencysituation;

– the order of 8 December 2005 concerning the medicalaptitude check-up, radiological surveillance and

training or information of the personnel involved inmanaging a radiological emergency situation.

1 2 6 Protection of the population in a long-termexposure situation

In recent years, and on a case by case basis, the GeneralDirectorate for Health (Ministry for Health) set clean-outthresholds for sites contaminated by radioactive materials.These were sites which had been contaminated by a nucle-ar activity in the recent or more distant past (use ofunsealed sources, radium industry, etc.) or an industrialactivity using raw materials containing significant quanti-ties of natural radioelements (uranium and thorium fami-lies). Most of these sites are listed in the inventory dis-tributed and periodically updated by ANDRA.

This approach has today been abandoned in favour of acomplete methodological approach defined in the IPSNguide (methodology guide for sites contaminated by radioac-tive materials, version 0, December 2000), produced at therequest of the ministries for Health and the Environment,and distributed to the préfets (DRIRE and DDASS/DRASS).

Based on the current and future uses of the land andpremises, this guide proposes a number of steps for localdefinition of rehabilitation targets expressed in terms ofdoses. The parties concerned (owners of the site, localelected representatives, local residents, associations) areinvolved in the process. Operational values for decontami-nation can then be set for each case.

This new approach now has a regulatory framework in arti-cle R. 1333-90 of the Public Health Code.

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Definition of a radiological emergency situation (article R. 1333-76 of the Public Health Code)

“There is a radiological emergency when an event is likely to lead to the emission of radioactive materials or to a level of ra-dioactivity such as to constitute a hazard for public health, in particular with reference to the limits and response levels setin articles R. 1333-8 and R. 1333-80 respectively. This event may be the result of:

1°) an incident or accident occurring during the performance of a nuclear activity defined in article L. 1333-1, including thetransport of radioactive materials;

2°) a malicious act;

3°) environmental contamination detected by the environmental radioactivity measurement network mentioned in articleR. 1333-11;

4°) environmental contamination made known to the competent authority as defined by international conventions oragreements, or decisions taken by the European Community on the subject of information in the event of a radiologicalemergency.”

1 3 Protection of individuals exposed for medicaland forensic purposes

The new regulations, implemented in March 2003, trans-posing above-mentioned directive 97/43/Euratom, werecompleted at the end of 2005. At the same time medicalpractitioners have engaged major initiatives to ease imple-mentation of this new device, promoting the establish-ment of good practices for procedures involving the use ofionising radiation.

Radiation protection for individuals exposed for medicalpurposes is now based on two regulatory principles: justifi-cation of the procedures and optimisation of exposure,which are under the responsibility of both the practitionersprescribing medical imaging examinations entailing expo-sure to ionising radiation and the practitioners carrying outthese procedures. They cover all the diagnostic and thera-peutic applications of ionising radiation, including radiolo-gical examinations requested for screening, occupationalhealth, sports medicine and in a forensic setting.

1 3 1 Justification of procedures

A written exchange of information between the prescri-bing practitioner and the practitioner carrying out theprocedure exposing the patient should justify the benefitof the exposure. This “individual” justification is requi-red for each procedure. However it will be based on ageneral justification of medical procedures using ionisingradiation, set out in good practices guides currentlybeing finalised by the various learned societies.

Prescription and performance guides for medical pro-cedures involving ionising radiation

Articles R. 1333-70 and R. 1333-71 of the Public HealthCode respectively refer to the publication of “prescrip-tion of routine procedures and examinations” guides(also called “indication guides”) and “performance ofprocedures involving exposure to ionising radiation”guides (called “procedure guides”). Under the impetus ofthe departments reporting to the Ministry for Health(DGSNR since 2002), the professionals represented bytheir learned societ ies , including the FrenchRadiotherapy and Oncology Society (SFRO), the FrenchRadiology Society (SFR), the French Nuclear Medicineand Molecular Imaging Society (SFMN), the Frenchmedical Radio-physics Society (SFPM), and variousorganisations representing dental practitioners, have setup the necessary working frameworks for drafting theseguides.

IRSN, the High Health Authority (HAS) and the NationalCancer Inst i tute (INCa) are also involved in this

approach. As applicable, ASN coordinates or supportsthis work, or is simply kept informed. The progress ofthe various guides is presented in the following table.

1 3 2 Optimisation of exposure

Optimisation in medical imaging (radiology and nuclearmedicine) consists in delivering the lowest possible dosecompatible with obtaining a quality image that providesthe diagnostic information sought for. Optimisation intherapy (external radiotherapy, brachytherapy andnuclear medicine) consists in delivering the prescribeddose to the tumour to destroy cancerous cells while limi-ting the dose to healthy tissues to the strict minimum.

The optimisation approach is thus a pledge of the qualityof the procedures conducted. Standardised guides forconducting procedures using ionising radiation have orare being prepared by health professionals to make opti-misation easier in practice (table 1).

Diagnostic reference levels

New statutory concepts specific to radiation protectionfor patients have been introduced for this very purposeand reference diagnostic levels were set in the order of12 February 2004. For radiology, this consists of dosevalues, while for nuclear medicine it consists of activitylevels administered in the course of the most common ormost heavily irradiating examinations. These referencelevels will be updated by conducting regular measure-ments or readings in line with the type of examination ineach radiology and nuclear medicine department andcentralising them at IRSN. Therefore, since June 2004,any new radiology appliances which enter service mustbe fitted with a device for estimating the dose deliveredduring an examination (article R. 5211-22 of the PublicHealth Code).

Dose constraints

In the field of biomedical research, where exposure toionising radiation is of no direct benefit to the indivi-duals exposed, dose constraints designed to limit thedoses delivered must be established by the physician.

Medical radiological physics

Special medical physics skills are called for in optimisingthe dose delivered to patients. The employment of a spe-cialised medical radiological physicist (PSRPM), formerlycalled a “radiophysicist”, has been extended to radiology,having already been compulsory in radiotherapy andnuclear medicine. Qualification of such specialistsinvolves obtaining a master’s degree (the list of suchdegrees was published in the order of 7 February 2005),followed by specialist training including clinical workplacements.

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The duties of this specialist have been specified andexpanded (order of 19 November 2004). Thus medicalradiological physics specialists must ensure the appro-priateness of the equipment, data and computing pro-cesses for determining and delivering the doses and acti-vity levels administered to the patient in any procedureinvolving ionising radiation. In the field of radiotherapythey guarantee that the radiation dose received by the tis-sues due to be irradiated matches that prescribed by theprescribing physician.

Furthermore, they estimate the dose received by thepatient during diagnostic procedures and play a part inquality assurance including inspecting the quality of themedical devices. Finally they contribute to teaching andtraining the medical and paramedical personnel in medi-cal radiological physics.

As part of the new measures, heads of establishments willhave to draw up plans for medical radiological physics asof the year 2005, defining the resources allocated, pri-marily in terms of staffing, in the light of the medicalpractices carried out in the establishment, the actual orprobable patient numbers, existing dosimetry skills andresources allocated to quality assurance and control.

Maintenance and quality control of medical devices

Maintenance and quality control, both internal and exter-nal, of medical devices using ionising radiation (articlesR. 5211-5 to R. 5211-35 of the Public Health Code) havebeen mandatory since publication of the order of3 March 2003. Outside quality control is entrusted to

organisations approved by the Director General ofAFSSAPS who is responsible for issuing a decision todefine the acceptability criteria, the monitoring parame-ters and the frequency of the inspections on the medicaldevices concerned.

The following decisions were published:

– decision of 2 March 2004 concerning external qualitycontrol of external radiotherapy installations, modifiedby a decision of 27 July 2007;

– decision of 20 April 2005 setting the quality controlprocedures for bone mineral density test devices usingionising radiation;

– decision of 7 October 2005 concerning quality controlprocedures for analogue mammography installations,amended by a decision of 16 December 2005;

– decision of 30 January 2006 concerning quality controlprocedures for digital mammography installations;

– decision of 27 July 2007 setting the external qualitycontrol procedures for external radiotherapy installa-tions;

– decision of 27 July 2007 setting the internal qualitycontrol procedures for external radiotherapy installa-tions abrogating the decision of 2 March 2004 concern-ing electron accelerators used for medical applicationsand tele-cobalt therapy devices;

– decision of 24 September 2007 setting the quality con-trol procedures for certain radiodiagnosis installations,abrogating the decision of 20 November 2006;

– decision of 22 November 2007 setting the quality con-trol procedures for computed tomography scanners.

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Speciality Medical radiology Nuclear medicine Radiotherapy Dentalradiology

Documents Procedure Indication Procedure External Indicationguide guide guide radiotherapy and procedure

procedure guideguide

Start 09.1999 06.2001 09.1999 04.2004 01.2004

Interim reports 07.2000 03.2004 06.2004 10.2006 08.2005

Finalisation 10.2001* 10.2004 11.2007 05.2006(JFR 2001) (JFR 2004)

Availability www.sfrnet.org www.sfrnet.org www.sfmn.org – www.adf.asso.frwww.irsn.org www.irsn.org www.has.sante.fr

*Currently being updated

Table 1: Progress in the production of prescription and performance guides for medical procedures involving exposure to ionising radiation

Training and information

Additional major factors in the optimisation approach arethe training of health professionals and informingpatients. Work is continuing on finalising the mechanismintroduced in March 2003, through statutory channels.

Thus the objectives and content of training programmesfor practitioners conducting procedures using ionisingradiation, or who assist in these procedures, were definedin the order of 18 May 2004. This patients radiation pro-tection training is already part of initial medical trainingprogrammes and extends to other medical professionsinvolved in these procedures; on-the-job training, cur-rently being devised by learned societies and professionalbodies, will also be offered to working practitioners.

As regards the traceability of the data on the applicationof the justification and optimisation principles, the reporton the procedure, written by the medical practitionercarrying out the examination, must provide informationjustifying the procedures and the operations carried outand the data used to estimate the dose received by thepatient (order of 22 September 2006).

Finally, before carrying out a diagnostic or therapeuticprocedure using radionuclides, the physician must givethe patient oral and written guidelines on radiation pro-tection that are of use to the patient him/herself, his/herrelations, the public and the environment. In the event ofa therapeutically-oriented nuclear medicine procedure,

this information, issued in a written document, provideslifestyle hints to enable potential contamination to beminimised and states, for example, for how many dayscontacts with the spouse and children should be reduced.Recommendations (French High Public Health Council,learned societies) were distributed by ASN (January2007) to enable the content of the information alreadysent out to be harmonised.

1 3 3 Forensic applications of ionising radiation

In the forensic field, ionising radiation is used in a widevariety of sectors such as occupational medicine, sportsmedicine or for investigative procedures required by thecourts or insurance companies. The principles of justifi-cation and optimisation apply both to the personrequesting the examinations and the person who carriesthem out.

In occupational medicine, ionising radiation is used formedical supervision of workers (whether or not profes-sionally exposed to ionising radiation, for exampleworkers exposed to asbestos). A working group set upby ASN is examining the justification and optimisationof various procedures currently conducted, some ofwhich are required by the regulations.

The conclusions of this work will be available duringthe first half of 2008.

Approval criteria for the practice of external radiotherapy activities

Decree 2007-388 of 21 March 2007 defines the layout conditions for “cancer treatment” health care activities. The licenceissued by the Regional Hospitalisation Agency is granted for one or more therapies: surgery, external radiotherapy and bra-chytherapy, therapeutic use of unsealed source radionuclides and chemotherapy.

In the field of external radiotherapy, this licence takes the place of the previous high-risk equipment licence. The conditionsfor issue of the licence include:– the presence of a technical area which on the same site comprises at least two particle accelerators, one of which has anenergy level in excess of 15 MeV;

– compliance with the approval criteria defined by the National Cancer Institute (deliberations of the board of the INCa of20 December 2007). These criteria were defined with the participation of ASN and representatives of professional orga-nisations as well as the regional hospitalisation agencies. The criteria defined in particular include:• the use of 3-dimensional imaging on a scanner dedicated to treatment preparation;• the recording and verification of the treatment parameters by means of a dedicated IT system;• the use of in-vivo dosimetry;• periodic verification of the position of the patients and the geometrical properties of the beams;• the presence of a radiation therapist and a radiological physicist for the duration of patient treatment.

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Radiotherapy quality assurance

After publication of the report from the inquiry carried out jointly by ASN and IGAS into the radiotherapy incident in Épi-nal, ASN was given responsibility for developing a radiotherapy quality assurance system designed to prevent patient expo-sure errors and significantly improve the safety of radiotherapy treatment.

The quality management system, based on ISO 9000, was prepared by ASN with the contribution of HAS, INCa, MeaH,SFRO, SFPM and AFSSAPS. It should become enforceable on the basis of a technical decision from ASN. ASN considersthat 4 main points of interest must be underlined:1. creation of a quality management system including a pertinent documentary system,2. management of human resources and, to a lesser extent, of material resources,3. management of performance of radiotherapy treatment, from the first patient consultation to post-treatment follow-up,4. finally, continuous quality improvement through supervision and the implementation of monitored corrective measures.

This quality management system is accompanied by a guide which aims to provide clarifications and recommendations tomake it easier to apply, along with technical data sheets offering examples or proposing practical support tools.

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*Administrative region headed by a préfet.

1 4 Protection of individuals exposed to technologi-cally enhanced naturally occurring radioactivematerials (TENORM)

1 4 1 Protection of individuals exposed to radon

The regulations applicable to management of the radon-related risk in premises open to the public (article R.1333-15 of the Public Health Code) introduce the fol-lowing clarifications:

– the radon monitoring obligation applies in geographi-cal areas in which radon of natural origin is likely tobe measured in high concentrations and in premises inwhich the public is likely to stay for extended periods;

– the measurements will be made by organisationsapproved by ASN, these measurements being repeatedevery 10 years and whenever work is carried out tomodify the ventilation or the radon tightness of thebuilding.

In addition to introducing action trigger levels of 400and 1000 Bq/m3, the implementing order of 22 July2004 concerning management of the radon risk in pre-mises open to the public defined geographical areas andpremises open to the public for which radon measure-ments are now mandatory: the geographical areas corres-pond to the 31 départements* classified as having priori-ty for radon measurement (see map enclosed); the

categories of premises open to the public cover teachinginstitutions, health and social institutions, spas andpenitentiaries.

The obligations of the owner of the facility are also spec-ified when the action trigger levels are found to havebeen exceeded.

The conditions for accreditation of the organisationsauthorised to carry out activity concentration measure-ments were defined in the order of 14 July 2006 con-cerning the accreditation of organisations responsible formeasuring radon. The list of approved organisations wasupdated in the order of 25 July 2006, after obtaining theopinion of the accreditation commission consisting ofrepresentatives of the Ministries concerned, technicalorganisations (IRSN, Scientific and Technical Centre forthe Building Industries, French High Public HealthCouncil), building professionals and professionalsinvolved in radon measurements. The list of approvedorganisat ions is avai lable on the ASN websi te ,www.asn.fr.

The order of 22 July 2004 was accompanied by thepublication in the Official Gazette of an opinion definingthe applicable standards for radon measurement (O.G. of12 August 2004) and an opinion concerning the defini-tion of the action and work to be done if the action trig-ger levels of 400 and 1000 Bq/m3 (O.G. of 22 February2005) were to be exceeded.

Map of the 31 priority départements for radon measurement

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In the residential field, the National health and environ-ment plan has defined a number of priorities whichinclude regulatory action to deal with the radon risk:

– setting up a radon diagnosis to improve informationmade available to future real estate buyers and tenants;

– definition of construction rules for newly built accom-modation located in the priority areas.

Finally, in the working environment, the new articleR. 231-115 of the Labour Code requires the head of thefacility to take radon activity measurements and take thesteps needed to reduce exposure when the measurementresults reveal an average radon concentration of morethan 400 Bq/m3. An order defining the workplaces inwhich these measurements are required should be publi-shed in 2008.

1 4 2 Other sources of exposure to TENORM

Professional activities which use materials which natural-ly contain radionuclides not used for their intrinsicradioactive properties but which are likely to create expo-sure such as to harm the health of workers and the public

(“enhanced” natural exposure) are subject to the provi-sions of the Labour Code (art. R. 231-114) and thePublic Health Code (art. R. 1333-13).

The order of 25 May 2005 defines the list of occupationsusing raw materials naturally containing radioelements,the handling of which can lead to significant exposure ofthe population or of workers. The following are thereforeconcerned:

– coal combustion in thermal power plants;

– processing of tin, aluminium, copper, titanium, nio-bium, bismuth and thorium ores;

– the production of refractory ceramics as well as glass-making, foundry, steelmaking and metallurgical activi-ties employing them;

– the production or use of compounds comprising tho-rium;

– the production of zircon and baddeleyite, and foundryand metallurgical activities employing them;

– the production of phosphated fertilisers and the manu-facture of phosphoric acid;

– processing of titanium dioxide;

– processing of rare earths and production of pigmentscontaining them;

– treatment of underground water by filtration intendedfor the production of:• water intended for human consumption• mineral waters;

– Spas.

For these activities, the Public Health Code now containsan obligation to proceed with a study to estimate thedoses to which the population is subjected. The Ministerfor Health may also implement measures to protect thepublic against ionising radiation, should this provenecessary in the light of the estimations made. Whenthese activities fall into the category of classified installa-tions, these measures will be defined by the correspon-ding applicable regulations.

In addition, and if protection of the public so warrants, itwill also be possible to set radioactivity limits for theconstruction materials and consumer goods produced bysome of these industries (art. R. 1333-14 of the PublicHealth Code). This measure complements the ban on theintentional addition of radioactive materials to consumergoods.

For professional exposure resulting from these activities,a dose evaluation process, under the responsibility of thehead of the facility, was introduced into the Labour Code.Should the dose limit of 1 mSv/year be exceeded, steps toreduce exposure should be taken. The above-mentionedorder of 25 May 2005 offers clarification of the technicalmeasurement procedures for evaluating the dosesreceived by the workers.

Finally, the Labour Code (art. R. 231-116) stipulates thatfor aircrews l ikely to be exposed to more than 1mSv/year, the head of the facility must evaluate the expo-sure, take steps to reduce the exposure (particularly inthe event of a declared pregnancy) and inform the per-

sonnel of the health risks. The order of 7 February 2004defines the procedures for implementing these measures.

1 5 Radiological quality of water intended forhuman consumption and foodstuffs

Council directive 98/83/CE of 3 November 1998 concer-ning the quality of water intended for human consump-tion, transposed into national law by decree 2001-1220of 20 December 2001 on water intended for humanconsumption, with the exception of natural mineralwaters, set radiological quality criteria for waters inten-ded for human consumption. Two quality indicatorsconcerning radioactivity were taken into account: tri-tium and the total indicative dose (TID). The referencelevel for tritium was set at 100 Bq/l, and that of the TIDat 0.1 mSv/year. Tritium is considered to be an indicatorcapable of revealing the presence of other artificial radio-nuclides, while the TID covers both natural radioactivityand radioactivity due to the presence of artificial radio-nuclides.

On this basis, the 12 May 2004 order setting out theprocedures for control of the radiological quality ofwater intended for human consumption, implementingthe above-mentioned decree of 20 December 2001,defined new radiological inspection programmes forpublic mains water and non-mineral bottled waters, aswell as two guideline values: the total alpha activity, setat 0.1 Bq/L and the total beta activity, set at 1 Bq/L.Since 1 January 2005, health checks on the radiologicalquality of water intended for human consumption havebeen mandatory and have been carried out by theDepartmental Health and Social Action Directorates(DDASS). A circular from the General Directorate forHealth (DGS) dated 13 June 2007, accompanied by

Implementation of the regulations to professional activities which use naturally occurring radioactive materials (NORM) notspecifically used for their radioactive properties, has led the industries concerned to submit the studies requested by the PublicHealth Code and the Labour Code. These studies, of which there are fifty to date, allow an assessment of the radiological riskto the workers and to the population, and can be broken down according to the sectors concerned in the following way:– coal combustion in thermal power plants: 10– the production of refractory ceramics as well as glassmaking, foundry, steelmaking and metallurgical activities employingthem: 25

– the production of zircon and baddeleyite, glassmaking and metallurgical activities employing them: 5– the production of phosphated fertilisers and the manufacture of phosphoric acid: 1– processing of titanium dioxide: 3– processing of rare earths and production of pigments containing them: 1– treatment of underground water by filtration: 1– spas: 1– others: 3

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The BNI regulations are to a large extent based on inter-national conventions and on standards issued by theInternational Atomic Energy Agency (IAEA), under theaegis of the United Nations.

The Nuclear Safety Convention, in force since 1996, con-cerns civil nuclear power generating reactors. It defines acertain number of safety objectives and appropriate mea-sures. Its counterpart in the field of spent fuel andradioactive waste management is the Joint Convention onthe Safety of Spent Fuel Management and the Safety ofRadioactive Waste Management, in force since 2001.

IAEA publishes reference texts, called “Basic SafetyStandards”, describing the safety principles and practicesthat can be used by States as the foundation for theirown national regulations. These documents are notbinding. They concern installation safety and radiationprotection, the safety of waste management and the safetransport of radioactive materials.

At a Community level, the only two texts dealing withnuclear safety are Council resolutions of 22 July 1975and 18 June 1992 concerning technological nuclear safe-ty problems and asking the member States and theCommission to reinforce cooperation through significantjoint actions to tackle fundamental safety issues. Fortheir part, the members of WENRA (association createdat the initiative of ASN in 1999), which brings togetherthe 17 heads of the regulatory bodies in the “nuclear”countries of the European Union plus Switzerland, havefor the past few years being working on a programme toharmonise technical rules in the two areas of nuclearinstallation safety and the management of spent fuel andradioactive waste.

At a national level, BNI regulations are now covered bythe “BNI procedures” decree (2007-1557 of 2 November2007), implementing article 36 of the TSN Act.

The “BNI procedures” decree abrogated decree 63-1228of 11 December 1963 concerning nuclear installationsand decree 95-540 of 4 May 1995 concerning BNI dis-charges of l iquid and gaseous effluents and waterintake. It defines the new framework henceforth appli-cable to BNI procedures and deals with the entire lifecy-cle of a BNI: from its authorisation decree to commis-sioning, to final shutdown and decommissioning.Finally, it explains the relations between the ministersresponsible for nuclear safety and ASN in the field ofBNI safety.

It creates the BNI Consultative Committee (CCINB), anew body for consultation concerning the regulatorytexts and the main individual decisions affecting BNIs. Itspecifies the applicable procedures for adoption of thegeneral regulations and for individual decisions concer-ning BNIs. It defines the procedures for implementationof the law concerning inspection and the administrativeor legal penalties. Finally, it defines the particular condi-tions for implementation of certain regimes within theperimeter of basic nuclear installations.

2 1 Authorisations and licences

Part IV of the “TSN Act” contains an authorisationdecree procedure followed by a series of licences issuedthroughout the life of a BNI: creation, commissioning,possible modification of the installation, final shutdownand decommissioning.

2 1 1 Siting

Construction of a BNI requires issue of a building permitby the préfet, according to procedures specified in arti-cles R. 421-1 and following of the Town Planning Code.

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recommendations from ASN, specifies the policy under-pinning this new regulation.

Several European regulations (Council Regulations n°3954/87 of 22 December 1987 laying down maximumpermitted levels of radioactive contamination of food-stuffs and of feedstuffs following a nuclear accident or inany other case of radiological emergency, CouncilRegulation n° 2219/89/EEC of 18 July 1989 on the spe-

cial conditions for exporting foodstuffs and feedingstuffsfollowing a nuclear accident or any other case of radio-logical emergency) were adopted subsequent to theChernobyl accident, to establish the maximum allowablelevels of radioactivity in contaminated foodstuffs.

These levels, along with the values of the Codex alimen-tarius for international trade, revised in 2007, areappended to this chapter.

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C H A P T E R

REGULATIONS3

LICENSEEapplication for an

authorisation decree

PRÉFETorganises thepublic inquiry

IRSNissues an opinion

Publicinquiry

GPEissues an opinion

Opinionof the licensee

Opinionof the CCINB*

Authorisationdecree

I

MINISTERS

in charge of nuclearsafety

(Environment + Industry)

ASNreviews

thedossier

ASNacknowledges

receipt

ASNproposes a draft

authorisation decreeapplication (DAC)

Opinionof ASN

ASNrequirements

Opinion

MINISTERS

submita draft DAC

*it to replace the Interministerial Commission for Basic Nuclear Installations (CIINB)

Basic nuclear installations authorisation decree procedure under the law of 13 June 2006

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Well before applying for a BNI authorisation decree, thelicensee informs the administration of the site(s) onwhich it plans to build this installation.

This analysis deals with socio-economic aspects and safe-ty. For its part, ASN analyses the safety-related characte-ristics of the sites: seismicity, hydrogeology, industrialenvironment, cold water sources, etc.

Furthermore, pursuant to articles L.121-1 and followingof the Environment Code, BNI creation entails the hol-ding of a public debate:

– systematically, in all cases when dealing with a newelectricity generating site or a new site not generatingelectricity and costing more than € 300 million;

– possibly, when dealing with a new site not generatingelectricity from nuclear power and costing between €

150 million and € 300 million.

Public debates were held in 2006 to discuss the buildingof an EPR type nuclear reactor at Flamanville and thelocation of the ITER research reactor in Cadarache.

2 1 2 Safety options

Anyone intending to operate a BNI may, even beforestarting the licensing procedure, ask ASN for an opinionon all or part of the safety options of its installation. Theapplicant is notified of the ASN opinion and will pro-duce any additional studies and justifications as neces-sary for a possible authorisation decree application.

The safety options will then be presented in the authori-sation application file, in the form of a preliminary safetycase.

ASN generally asks a competent Advisory Committee ofexperts (GPE) to review the project. Their report is thensent to the licensee so that it can familiarise itself withthe issues which will need to be addressed in its authori-sation decree application.

This preparatory procedure in no way exempts the appli-cant from the subsequent regulatory examinations butsimply facilitates them.

2 1 3 Plant authorisation decrees

A BNI authorisation decree application is submitted bythe person in charge of operating the installation, whothus acquires the status of licensee, to the ministers

responsible for nuclear safety. The application is accom-panied by a file comprising several items, including thedetailed drawing of the installation, the impact assess-ment, the preliminary safety case, the risk managementstudy and the decommissioning plan

ASN is responsible for reviewing the file, jointly with theministers responsible for nuclear safety. This is followedby a period of parallel consultation of the public andtechnical experts.

The public inquiryThe authorisation decree can only be issued after apublic inquiry as provided for in I of article 29 of theTSN Act.

The authorisation decree application and its correspon-ding file are submitted to a public inquiry by the préfet.

The public inquiry is opened at least in each of the com-munes* which is situated, at least in part, less than fivekilometres from the perimeter proposed by the licensee.The file submitted to the public inquiry must notablyinclude the authorisation application, specify the identi-ty of the applicant, the purpose of the inquiry, the natureand basic characteristics of the installation and comprisea plan of it, a map of the region, a hazard analysis andan environmental impact assessment.

A copy of the file submitted to the public inquiry is sentfor information to the mayor of each of those communesin the area in which the operation is to be carried out,but the town hall of which is not selected for holding theinquiry.

In addition to the préfecture concerned, a descriptive fileand an inquiry register are made available in all com-munes completely or partially within a 5 km radiusaround the planned installation. If this radius encom-passes the territory of several départements, a joint orderof the préfets concerned organises the inquiry in eachdépartement, with the préfet of the main site of the opera-tion co-ordinating the procedure.

In accordance with general provisions in this respect, thepublic inquiry shall proceed for a minimum period ofone month and a maximum period of two months, withthe possibility of a two week extension in the event of awell-founded decision in this matter on the part of theInquiry Commissioner.

The purpose of the inquiry is to inform the public andcollect opinions, suggestions and counter-proposals, insuch a way as to provide the competent authority with

*Smallest administrative subdivision administered by a mayor an a municipal council

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all the elements necessary for its own information. Soany interested person, whatever his nationality or placeof residence, is invited to express his opinion.

An Inquiry Commissioner (or an Inquiry Committee,depending on the nature or extent of the operations) isnominated by the Pres ident of the competentAdministrative Court. He may receive any document,visit the site, arrange to meet all people wishing to makestatements, organise public meetings and request exten-sion of the inquiry period.

When the inquiry is over, he examines the observationsof the public entered into the inquiry register or sent tohim directly. Within the month following the end of theinquiry, he sends a report containing his recommenda-tions to the préfet.

In each département concerned by the public enquiry, thepréfet also consults the General Council and the LocalCouncils in those communes where the public enquiry istaking place, as well as the State regional offices he feelsto be concerned by the application.

No later than fifteen days following receipt of the reportand the conclusions of the enquiry commissioner, thepréfet forwards them to the Ministers responsible fornuclear safety and to ASN, with his opinion, along withthe results of all the consultations carried out.

The creation of a local information committee (CLI)

By giving them a legislative basis, the TSN Act hasstrengthened the role of the CLIs (see chapter 6 point 3).

A CLI is set up for all sites comprising one or moreBNIs.

Its role is a general one of supervision, information andconsultation concerning nuclear safety, radiation protec-tion and the impact of nuclear activities on people and theenvironment. It comprises representatives from the gene-ral councils, local councils or joint council assemblies andthe regional councils concerned, elected members ofParliament from the region, representatives of environ-mental protection associations, economic interests andpertinent employee trade unions and the medical profes-sions, as well as qualified personalities. ASN representa-tives and other State departments concerned, as well asrepresentatives of the licensee, may attend the sessions ofthe local information committee on a consultative basis.

The CLI may forward to ASN and the ministers responsi-ble for nuclear safety or radiation protection all ques-tions concerning nuclear safety and radiation protectionas related to the site.

It can obtain from the licensee, ASN and other Statedepartments all documents and information it may needto perform its duties.

Consultation of technical organisationsThe preliminary safety case appended to the authorisa-tion decree application is transmitted to ASN, whichsubmits it for review to one of the Advisory Committeesof Experts reporting to it, following a report from IRSN.

Further to its investigation and the results of the consul-tations, ASN sends the Ministers responsible for nuclearsafety a proposal for drafting of a decree either authori-sing or rejecting creation of the installation.

Authorisation decreeThe Ministers responsible for nuclear safety send thelicensee a draft decree granting or rejecting authorisa-tion. The licensee has a period of two months in whichto present its observations.

After consulting the licensee, the ministers responsiblefor nuclear safety finalise the draft decree and forwardthis draft and the file submitted to the public inquiry tothe CCINB for its opinion.

The CCINB is required to submit its opinion within twomonths. The Ministers responsible for nuclear safety askASN for its opinion concerning the draft authorisation orrejection decree, possibly as amended to take account ofthe opinion of the CIINB.

ASN’s opinion is deemed to be favourable if not returnedwithin two months.

The authorisation decree for a BNI is issued by the PrimeMinister, countersigned by the ministers responsible fornuclear safety.

The authorisation decree sets the perimeter and charac-teristics of the installation and the particular rules bywhich the licensee is bound.

The authorisation decree also sets the duration of thelicence and the time by which the installation must becommissioned. It also specifies the essential elementsrequired to protect public health and safety and to pro-tect nature and the environment.

The requirements defined by ASN for application ofthe authorisation decreeFor application of the authorisation decree, the ASN usesits technical regulatory powers to define requirements con-cerning the design, construction and operation of the BNIthat it considers to be necessary to protect public healthand safety and to protect nature and the environment.

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These requirements may in particular concern the quali-ty of the design, construction and operation of theinstallation, its protection and security systems, emer-gency resources, the ventilation and discharge systems,protection against earthquakes, radiological protection ofthe environment and workers, transport of radioactivematerials, installation modifications, final shutdown anddecommissioning.

As and when necessary, ASN in particular specifies therequirements concerning BNI water intake and theradioactive materials discharged from the BNI. The spe-cific requirements setting limits on the discharges fromthe BNI into the environment must be approved by theMinisters responsible for nuclear safety.

Installation modificationsThe licensee advises ASN of any modifications to theinstallation entailing an updating of the general opera-ting rules or the on-site emergency plan.

A new authorisation decree, examined as previouslydescribed for the authorisation decree, must be obtainedif there is a change in licensee, a modification of theperimeter or a significant change to the installation.

A modification is considered to be significant if:

– there is a change in the nature of the installation or anincrease in its maximum capacity;

– there is a change in the key elements regarding protec-tion of the interests mentioned in I of article 28 of the13 June 2006 Act, mentioned in the authorisationdecree;

– a new BNI mentioned in III of article 28 of the above-mentioned law of 13 June 2006 is added within theperimeter of the installation and its operation is linkedto that of the installation in question.

The other installations located within a BNI perimeterTwo types of installation exist side by side within a BNIperimeter:

– equipment and installations which are part of a BNI:these are elements of this installation which are neces-sary for it to operate; depending on its type, thisequipment can in technical terms be compared to clas-sified installations but, as a part of the BNI, it is sub-ject to the procedure applicable to BNIs;

– classified equipment and installations which are notnecessarily linked to the BNI: this equipment andthese installations are subject to the legislation applica-ble to installations classified on environmental protec-tion grounds (ICPE) as specified in part I of Book V ofthe Environment Code.

The equipment necessary for BNI operation is fully cove-red by the BNI regime specified in the “BNI procedures”

decree. The other equipment subject to another regime(water or ICPE) but located within the perimeter of theBNI remains subject to this regime, but with a change incompetent party, as individual measures are no longertaken by the préfet, but by ASN.

2 1 4 Operating licences

Commissioning corresponds to first use of radioactivematerials in the installation or the first operation of aparticle beam.

Prior to commissioning, the licensee sends ASN a filecomprising the safety case, the general operating rules, awaste management study, the on-site emergency planand the decommissioning plan.

After checking that the installation complies with theobjectives and rules defined by the TSN Act and itsimplementing texts, ASN authorises commissioning ofthe installation.

ASN’s authorisation decision is mentioned in its OfficialBulletin. ASN notifies the licensee of its decision andcommunicates it to the ministers responsible for nuclearsafety and to the préfet. It may also forward it to thelocal information committee.

Prior to or on completion of the authorisation proce-dure, partial commissioning may however be authorisedby decision of ASN, published in its Official Bulletin, fora limited period and with regard to one of the followingcategories:

– performance of particular installation operating testsrequiring that radioactive materials be brought into it;

– arrival of nuclear fuel within the perimeter of a reactor,prior to first loading of fuel into this reactor.

2 1 5 Final shutdown and decommissioning licences

The final shutdown and decommissioning licensingprocedureAt least one year before the date scheduled for finalshutdown, the licensee submits the authorisation requestto the ministers responsible for nuclear safety.

The licensee sends ASN a copy of its application alongwith the file necessary for its examination.

The final shutdown and decommissioning authorisationapplication is in the same way subject to the consulta-tions and inquiries applicable to the BNI authorisationdecree applications.

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Importance of the modification--- +

Modificationof requirements

at initiativeof ASN

Reviewby ASN

ASNdecision

OR

ASN decisionapproved bythe Ministersresponsiblefor nuclear

safety(if the decision

concernsdischarge limits)

Application submittedto Ministers responsible

for nuclear safetyand ASN

ASNreview

Modificationof authorisationdecree by theGovernment

Applicationsubmitted to

Ministersresponsible fornuclear safety

and ASN

ASN reviewand

publicinquiry

Modificationof authorisation

decreeby the

Government

Changein licensee

Changein BNI

perimeter

Significant*modificationof the BNI

* Definition of significant modification of a BNI: a change in its nature or rise in its capacity, a change in the key aspects regarding the protection ofpublic health and safety, nature and the environment, the addition of a new BNI within the perimeter of the initial BNI.** This time allows ASN to proceed with a new review or issue additional requirements.

Notification

Review byASN

Expressapproval by ASN

OR

ImplicitASN approvalon expiry of a

6 monthperiod,

renewableonce*

Operation ofminor

importance(art.27)

Exemptionfrom notification

if licensee’sinternal

supervisoryarrangementapproved by

ASN

Operation coveredby a licensee’s internal supervisory

arrangement approved by ASN

YES NO

Non-significant modifications

Article 26 Article 25 Article 29 Article 30 Article 31

Types of BNI modifications covered by the “BNI procedures” decree

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Two licensing systems coexist, one for general cases andone for radioactive waste disposal facilities:

General case:

– the licence application contains requirements concer-ning the shutdown conditions, the decommissioningand fuel management procedures, and the surveillanceand subsequent maintenance of the installation site;

– the licence is granted by decree, subject to the opinionof ASN, setting the dismantling characteristics, thetime allotted for decommissioning and the types ofoperations for which the licensee is responsible afterdecommissioning.

Radioactive waste disposal facilities:

– the licence application contains requirements concer-ning final shutdown and subsequent maintenance andsurveillance of the site;

– the licence is issued by decree, subject to the opinionof ASN, setting the types of operations for which thelicensee is responsible after final shutdown.

Performance of final shutdown and decommissioningoperationsFor installations other than radioactive waste disposalfacilities, the final shutdown and decommissioning ope-rations comprise two successive phases of work:

– final shutdown operations, which mainly consist ofdisassembly of the equipment outside the nuclearisland and not required for continued monitoring ofnuclear island safety, maintaining or reinforcing of thecontainment barriers or establishing a radioactivitybalance;

– decommissioning work on the nuclear part of theplant. This work can start as soon as the decommis-sioning operations are completed or can be delayedwith a view to taking advantage of radioactive decay incertain activated or contaminated materials.

In some cases, operations such as the unloading andremoval of nuclear material, the disposal of fluids, ordecontamination and clean-out operations can be perfor-med under the provisions of the authorisation decree forthe plant considered. To do so, these operations mustensure compliance both with previously imposed requi-rements and with the safety case and general operatingrules currently in force, albeit with minor modificationsif necessary. In all other cases, such operations comeunder the provisions of the final shutdown and decom-missioning decree.

Insta l lat ion del icensing and publ ic protect ionrestrictionsIf decommissioning work is taken as far as the final tar-get state, as validated by ASN, the installation can bedelicensed and removed from the BNI list in accordance

with the procedure specified in its final shutdown anddecommissioning licence.

The delicensing application in particular contains a pre-sentation of the site after decommissioning, giving ananalysis of the state of the soil and a description of anyremaining installation constructions and their state.

In order to keep a trace of the past existence of a BNI ona site and make provision for any limitations on thefuture use of the installation, public protection restric-tions may be implemented after delicensing or disap-pearance of the installation and concern the use of thesoil in and around the installation. These protectionrestrictions are created in accordance with article 31 ofthe above-mentioned law of 13 June 2006, further to theopinion of ASN, in the conditions laid down in articlesL. 515-8 to L. 515-12 of the Environment Code.

Public protection restrictions concerning the use of thesoil and performance of work subject to notification oradministrative authorisation may also be implemented,pursuant to article 31 of the law of 13 June 2006, onexisting installations, including installations in service.

2 2 General technical regulations

The general technical regulations comprise all generaltexts laying down technical rules for nuclear safety,whether regulatory (orders) as specified in article 30 ofthe above-mentioned law of 13 June 2006 or related(circulars, basic safety rules, guides).

2 2 1 Ministerial and government orders

Pressure vesselsBNIs comprise two types of pressure vessels: those whichare specifically nuclear, in other words those which con-tain radioactive materials, and those which are more con-ventional and which are not specific to nuclear facilities.

The applicable regulations are detailed in table 1.

Quality organisationThe order of 10 August 1984 concerning the quality of thedesign, construction and operation of basic nuclear instal-lations (“quality order”) specifies the steps to be taken by aBNI licensee for defining, obtaining and maintaining thenecessary quality of its installations and operating condi-tions, in order to guarantee its safety.

It thus stipulates that the licensee must define qualityrequirements for each activity concerned, employ theappropriate skills and methods for meeting these quality

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requirements and finally, guarantee quality by checkingappropriate compliance with these requirements.

It also specifies:

– that detected discrepancies and incidents be thoroughlycorrected and that preventive action be taken;

– that suitable documents testify to results obtained;

– that the licensee supervise the service companies usedand check compliance with procedures adopted to gua-rantee quality.

Operating experience feedback from incidents and acci-dents occurring in BNIs and the findings of the inspectionsconducted, enable ASN to analyse the various problems inorder to assess the implementation of the abovementionedorder of 10 August 1984.

A draft revision of the quality order has been produced,aiming to bring it into line with the WENRA reference levels.This order should be replaced by one dealing with BNI safetypolicy and management. As part of the WENRA referencelevels transcription process, five working groups have beendrafting texts (order and guides) since the beginning of 2006in the following areas: safety policy and management (allBNIs); safety approach; pressurised water reactor (PWR)design; PWR operations and emergency situations.

Prevention of off-site detrimental effects and hazardsresulting from BNI operation

BNI operation can entail detrimental effects and hazardsfor the environment in the broadest sense, that is for thesurrounding installations and their workers, but also for

the public and the environment off the site. The policyconducted by ASN with respect to environmental protec-tion is described in Chapter 5. It primarily aims to preventand minimise the risks for the installations by ensuringthat the following are applied:

– the order of 31 December 1999 stipulating the generaltechnical regulations designed to prevent and mitigatethe harmful effects and external hazards resulting fromoperation of basic nuclear installations;

– ICPE legislation for installations of this type within theBNI perimeter.

The order by the ministers for the Environment andIndustry of 31 December 1999, as amended by the above-mentioned order of 31 January 2006, sets the general tech-nical regulations for preventing and mitigating off-sitedetrimental effects and hazards resulting from BNI opera-tion, with the exception of water intake and discharge ofeffluents. It introduces principles concerning waste man-agement, prevention of accidental pollution, fire, light-ning, criticality and radiolysis applicable to all nuclearequipment, including that which is situated outside thesensitive parts of the BNIs. Implementation of this textensures that environmental protection concerns are takeninto account by the licensees at a level comparable withthat required for non-nuclear industrial installations.

2 2 2 Documents produced by ASN

Technical regulatory decisionsPursuant to article 4 of the TSN Act, ASN issues deci-sions to supplement the implementation procedures for

Nuclear Conventional

Main primary Main secondaryOther equipmentsystem of pressurised systems of pressurised

water reactors water reactors

Construction • Decree of 2 April 1926 • Decree of 2 April 1926• Decree 99-1046 of

• Order of 26 • RFS II.3.8 of13 December 1999

February 1974(1) 8 June 1990(1)

or Order of 12 December 2005

Operation • Order of 10 November 1999 • Decree of 2 April 1926 • Decree 99-1046 of• Decree of 18 January 13 December 1999

1943(1) • Order of 15 March 2000

(1) As of 2011, the order of 12 December 2005 will apply to the construction and operation of nuclear pressure vessels, except for the operational aspects of the main primary and main secondary sys-tems of pressurised water reactors.

• Decree of 2 April 1926• Decree of 18 January 1943 or

• Decree 99-1046 of13 December 1999

Table 1: regulation of pressure vessels

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the decrees and orders issued concerning nuclear safetyor radiation protection, except for those dealing withoccupational medicine.

They require approval by the Ministers responsible fornuclear safety when they concern nuclear safety, or bythe Ministers responsible for radiation protection whenthey concern radiation protection.

These ASN decisions, as well as the mandatory opinionsit is required to issue concerning draft decrees, arepublished in its Official Bulletin, available on-line fromits website.

Basic safety rules and ASN guidesOn a variety of technical subjects, concerning bothPWRs and other BNIs, ASN has drafted basic safety rules(RFS). These are recommendations which specify safetyobjectives and describe practices ASN considers to beadequate for compliance with them.

They are not, strictly speaking, regulatory documents. ALicensee may decide not to follow the specifications ofan RFS if it can demonstrate that the alternatives it pro-poses employing enable the stipulated safety objectivesto be met.

In the light of the overhaul of the general technical regu-lations described in point 22, the RFS will be trans-formed into guides.

There are currently about forty RFS and other technicalrules issued by ASN, which can be consulted on the ASNwebsite (www.asn.fr).

2 2 3 French nuclear industry codes and standards

The nuclear industry produces detailed rules dealingwith the state of the art and industrial practices. Itgroups these rules in “Industrial codes”. These rulesallow effective transposition of the requirements of thegeneral technical regulations, while reflecting goodindustrial practice, thus facilitating contractual relationsbetween customers and suppliers.

In the particular field of nuclear safety, the industrialcodes used by the manufacturers and nuclear licenseesare drafted by the Association française pour les règlesde conception, de construction, et de surveillance enexploitation des matériels des chaudières électronu-cléaires (AFCEN), of which EDF and Framatome Areva

NP are members. The RCC codes of design and con-struction rules were drafted for the design, manufactureand commissioning of electrical equipment (RCC-E, 4thedition), civil engineering (RCC-G) and mechanicalequipment (RCC-M, 2000 edition). As of 1990, a codeof mechanical equipment in-service monitoring rules(RSE-M) was drafted to deal with this subject.

Production of these documents is the responsibility ofindustry rather than ASN, which is nonetheless taskedwith examining them to ensure their conformity with thegeneral technical regulations, in most cases leading todrafting of RFS, a guide or a decision, recognising theoverall acceptability on the date of the edition con-cerned.

The new version of the RCC-E code was accepted byASN in 2003. ASN in particular checked that this fourthedition of the code was consistent with RFS II.4.1.a of15 May 2000 concerning software in PWR safety-classi-fied electrical systems.

In the field of nuclear pressure vessels, these require-ments changed with the publication of the 12 December2005 order implementing the 13 December 1999 decreeon pressure vessels. The use of a code is now dependenton a demonstration of its conformity with the essentialsafety requirements defined in these texts. This arrange-ment thus enables the use of other construction codes tobe envisaged.

With regard to the RCC-M code, the AFCEN has under-taken a number of changes aimed at bringing it into linewith the previously mentioned requirements. ASN willexamine these changes.

The RSE-M code changed in October 2005, in particularto ensure conformity with the 10 November 1999 orderconcerning supervision of the operation of PWR reactormain primary system and main secondary systems. ASNcarried out an overall analysis of these changes. Withregard to the most important changes, this analysis con-cluded that the 2005 version of this code can today beapplied. However, this analysis will continue in 2008 inorder to reach an exhaustive ruling on all the modifica-tions presented.

Until such time as it issues a position on the proposedchanges to these codes, ASN considers that the acceptedversions of these codes, supplemented by any particularrestrictions and measures imposed, remain in force.

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3 REGULATIONS FOR THE TRANSPORT OF RADIOACTIVE MATERIALS

Unlike the technical safety regulations for installations,which are specific to each State, the International AtomicEnergy Agency (IAEA) has laid down an international basisfor transport safety and this constitutes the regulations forthe transport of radioactive materials, known as TS-R-1.

3 1 International regulations

This basis is used in the drafting of the transport safetyregulations in force: the ADR agreement (Europeanagreement on the international transport of dangerousgoods by road) for road transport, the regulations con-cerning international rail transport of dangerous goods(RID) for rail transport, the regulations for the transportof dangerous goods on the Rhine (ADNR) for river trans-port, the international maritime dangerous goods code(IMDG) for maritime transport and the technical instruc-t ions of the ICAO (Internat ional Civi l Aviat ionOrganisation) for air transport. These transport regula-tions have been fully transposed into French law andhave been implemented by government orders. ASN isfor this reason in contact with the administrationsresponsible for the various modes of transport (GeneralDirectorate for the Sea and Transports – DGMT andGeneral Directorate for Civil Aviation – DGAC) and hasa representative on the Interministerial Commission forthe Transport of Dangerous Goods - CITMD).

Transport safety is based on three main factors:

– first and foremost, on the engineered robustness of thepackages;

– on transport reliability and certain specially equippedvehicles;

– on an efficient emergency response in the event of anaccident.

Regulations are based on IAEA recommendations, whichspecify package performance criteria. The safety func-tions to be assured are containment, radiation protec-tion, prevention of thermal hazards and criticality.

The degree of safety of the packages is commensuratewith the potential harmfulness of the material transpor-ted. For each type of package, the regulations defineassociated safety requirements and testing criteria (seechapter 11, point 11).

ASN aims to intervene as early as possible in the draftingof the regulations, jointly with IRSN, in particular bytaking part in the various international or multinationalworking groups that exist to deal with the transport ofhazardous or radioactive goods.

In this context, ASN is a member of the IAEA TRANSSCCommittee (Transport Safety Standards Committee) andis represented as an expert in many working groups,organised according to transport mode, in cases whereradioactive material transport is at issue. An ASN repre-sentative thus took part in the meetings of the TRANSSCgroup held from 12 to 15 March and from 1 to 5October 2007 in Vienna. It also takes part in the“Regulatory transport safety group (RTSG)” which bringstogether the authorities of several countries and in

IAEA TS-R-1 regulations and maritime (IMDG) and air transport (IT ICAO) regulations

114

principle meets every two years. The last meeting tookplace in Vienna in January 2006.

ASN is also a member of the safety of radioactive materi-al transports standing working group of the DG Energyand Transport of the European Commission. In thisrespect, it took part in the meetings of this group on 12and 13 June and 11 and 12 December 2007.

3 2 National regulations

The orders applicable to each mode of radioactive mate-rial transport are as follows:– the order of 1 June 2001 as modified concerning thetransport of dangerous goods by road (known as the“ADR order”);

– the order of 5 June 2001 as modified, concerning thetransport of dangerous goods by rail (known as the“RID order”);

– the order of 5 December 2002 as modified, concerningthe transport of dangerous goods by inland waterway(known as the “ADNR order”);

– the order of 12 May 1997 as modified, concerning thetechnical conditions for the operation of aircraft by apublic air transport operator (OPS1);

– the order of 23 November 1987 as modified, division411 of the regulations for the safety of ships (RSN);

– the order of 18 July 2000 as modified, regulating thetransport and handling of dangerous goods in seaports.

These orders transpose in full the requirements of theinternational agreements and regulations in force.

ADR and RID regulations

Radiation protectionThe revision of the Public Health Code and the LabourCode now requires the updating of certain orders andthe publication of numerous decisions by ASN, by virtueof its regulatory powers.

As a priority, ASN will publish decisions concerning theupdating of the licensing and notification systems appli-cable to small-scale nuclear activities, the methods forcalculating the financial guarantees required of theradioactive source suppliers, management of the radonrisk in the workplace and definition of the radiotherapyquality control system.

In the field of radiation protection, a number of ordersfor implementation of the Public Health Code and theLabour Code are currently being drafted and should bereleased in 2008.

ASN is also actively participating in the work being doneto revise the basic radiation protection standards initiat-

ed by IAEA and the European Commission, which ispreparing a revision of the Euratom directives. Theserevisions will take account of the recommendations ofthe International Commission on Radiological Protection(ICRP) published at the end of 2007.

BNIThe 13 June 2006 Act concerning transparency andsecurity in the nuclear field brought about an in-depthoverhaul of the regulations concerning BNI safety.Pursuant to this Act, a number of decrees were adoptedto determine the new regime applicable to BNIs. Thesedecrees abrogated the decree of 11 December 1963 con-cerning nuclear installations and the decree of 4 May1995 concerning BNI liquid and gaseous effluents dis-charges and water intake.

An order from the Ministers responsible for nuclear safe-ty and a regulatory decision from ASN should be pub-lished in 2008 in order to complete the overhaul of theBNI procedures.

4 OUTLOOK

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The implementation of this new framework, plus theprocess of European harmonisation, will lead to a majorrevision and development of the general technical regu-lations applicable to BNIs. Work is proceeding on severalgovernment orders and regulatory decisions along theselines and drafting will continue during the course of2008.

With regard to individual decisions, if the main authori-sations concerning the life of a BNI (creation, final shut-down and decommissioning) remain within the remit ofthe Government, it is up to ASN to authorise BNI com-missioning and define the requirements regarding itsdesign, construction and operation pursuant to thedecrees. It is in this respect that ASN defines the require-ments concerning water intake into and liquid andgaseous discharge of materials from the installation,whether or not radioactive.

TransportsAs part of the transposition of directive 96/29/Euratom,transport companies carrying radioactive materials onthe national territory should, as of 2008, be bound by a

system of notification to or licensing by ASN. A decisionby ASN, approved by the ministers responsible fornuclear safety and transports, will specify the characte-ristics of the radioactive materials requiring either notifi-cation or licensing, the composition of the licensingapplication file and the items to be enclosed with thenotification, the review procedures and the conditionsfor renewal, revocation or suspension.

At the end of 2007, ASN was asked for an opinion bythe General Directorate for Sea and Transport (Ministryfor Transport), on the basis of article 62 of the “BNIProcedures” decree, with regard to the draft ordersamending the orders concerning the transport of dange-rous goods by road, by rail, by inland waterway, in seaports and concerning the safety of ships. In the field oftransport of nuclear materials, ASN should thus see itsrole as regulatory authority strengthened. In the case ofincidents or accidents, events concerning the transportof class 7 dangerous goods, that is radioactive materials,must be declared to ASN. This declaration must reachASN within two working days of detection of the eventand will constitute the accident declaration.

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1 The main values used in radiation protection

It is impossible to apply radiation protection ruleswithout metrology, as the most important exposure indi-cators for radiation protection are the doses received byman. Transposition of Council directive 96/29/Euratom

of 13 May 1996 laying down the basic safety standards

for the protection of the health of workers and the gene-

ral public against the risks arising from ionising radia-

tion enabled the definitions of the main values used in

radiation protection to be updated (appendix 13-7, regu-

latory part of the Public Health Code).

The absorbed dose D represents the quantity of energyabsorbed per unit mass of tissue. 1 gray (Gy) correspondsto the absorption of 1 joule per kilogram. This quantitydesignates the mean dose absorbed by a tissue, organ orthe whole body. However, the absorbed dose cannot bedirectly used in radiation protection because it does nottake account of the fact that the biological effects of theenergy intake depend on a number of parameters:– the quality of the radiation, in other words how itloses its energy in the micro-volumes along its path.This depends on its nature, whether electromagnetic(X or gamma rays) or electrically charged or unchargedparticle (alpha, beta or neutrons);

– the characteristics of the organ or tissue into which theenergy is taken, as not all tissues have the same sensi-tivity to radiation;

– the dose rate, that is the inclusion of the time factor inthe energy intake.

A large number of experiments have analysed the impor-tance of each of these factors with regard to the biologi-cal effects of irradiation. To manage all the dosesreceived by an individual, equivalent doses must be usedwhich take account of these exposure parameters.Weighting factors are thus applied to the “absorbeddose” when one wishes to define the “equivalent dose”which takes account of the nature of the radiation andthe “effective dose” which concerns the whole body.

APPENDIX 1VALUES AND UNITS USED IN RADIATION PROTECTION

Activity and becquerel

Activity (A) : the activity A of an amount of a radionuclide in a particular energy state at a given time is the quotient of dNby dt, where dN is the expectation value of the number of spontaneous nuclear transitions with emission of ionising radia-tion from that energy state in the time interval dt.

dNA = ——dt

The unit of activity of a radioactive source is the becquerel (Bq).

Absorbed dose and gray

Absorbed dose (D) : energy absorbed per unit mass

dED = ——dm

where:dE is the mean energy communicated by the ionising radiation to the matter in a volume element;dm is the mass of the matter in this volume element.The term “absorbed dose” designates the mean dose received by a tissue or an organ.

L’unité de dose absorbée est le gray (Gy).

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Equivalent dose, committed equivalent dose and sievert

Equivalent dose (HT): dose absorbed by the tissue or organ T, weighted according to the type and energy of the radiation R.It is given by the following formula:

HT,R = wR DT,R

where:DT,R is the mean for the organ or tissue T of the absorbed dose of radiation R;wR is the weighting factor for the radiation R.

When the radiation field comprises radiation of types and energies corresponding to different values of wR, the total equiva-lent dose HT is given by the formula:

HT = ∑ wR DT,R

The equivalent dose unit is the sievert (Sv).

The ICRP wR values, published in the order of 1 September 2003, are given in the following table. For the types of radiationwhich do not appear in the table, an approximate wR value is obtained from the mean quality factor determined by theICRU.

Type of radiation and energy range wR

Photons all energies 1Electrons and muons all energies 1Neutrons of less than 10 keV 5Neutrons from 10 to 100 keV 10Neutrons from 100 keV to 2 MeV 20Neutrons de 2 MeV à 20 MeV 10Neutrons of more than 20 MeV 5Protons of more than MeV 5Alpha particles 20

Committed equivalent dose [HT(ττ)]: integral over time (ττ) of the equivalent dose rate in the tissue or organ T to be recei-ved by an individual following the intake of radioactive material. For an intake or activity at time to, it is defined by the for-mula

to + τ

HT(τ) = ∫ HT (t) dtto

where:

HT (t) is the equivalent dose rate in the organ or tissue T at time t;τ the period over which intake is carried out.

In HT(τ), ττ is given in years. If the value of ττ is not given, for adults it is implicitly taken at fifty years and for children as thenumber of years remaining until the age of 70.

The committed equivalent dose unit is the sievert (Sv).

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Effective dose, committed effective dose and sievert

Effective dose (E): sum of the weighted equivalent doses delivered by internal and external exposure to the various tissuesand organs of the body. It is defined by the formla:

E = ∑ wT HT = ∑wT ∑ wR DT,R

T T R

where:

DT,R is the mean for the organ or tissue T of the absorbed dose of radiation R;wR is the weighting factor for the radiation R;wT is the weighting factor for the tissue or organ T.

The effective dose unit is the sievert (Sv).

Committed effective dose [E(τ)] : sum of the equivalent doses in the various tissues or organs [HT(τ)] following integration,each multiplied by the appropriate weighting factor wT. It is given by the formula:

E(τ) = ∑wTHT(τ)T

In E(τ), τ is the number of years of integration

The committed effective dose unit is the sievert (Sv).

The choice made in 1990 by the International Commission on Radiological Protection (ICRP) is to express doses by the effective dose, which is the result of an equivalence calculated in terms of a belated risk of radiation-induced fatal cancersand serious genetic consequences. The effective dose E is the result of a second weighting by a factor describing the relativeimportance of the effects on the tissues in which the dose is distributed. It is thus already the result of a modelling of therisk. The values of wT are given in the following table.

Tissue or organ wT

Gonads 0.20 Red marrow 0.12 Colon 0.12 Lungs 0.12 Stomach 0.12 Bladder 0.05 Breasts 0.05 Oesophagus 0.05 Thyroid 0.05 Liver 0.05 Skin 0.01 Bone surface 0.01 Others1 0.05

Comments - The choice of the same unit to express theequivalent dose, defined in an organ, and the effective

dose which takes account of all irradiated organs, is frequently a source of confusion.

1. For the calculations, the “other” organs are represented by a list of 12 organs for which there can be selective irradiation through internal contamina-

tion. If one of them concentrates most of the radionuclides, a wT of 0.025 is given to it, and a factor of 0.025 is given to the mean dose received by the

other 11 organs. the sum of the various wT is equal to 1, which corresponds to uniform irradiation of the whole body. The wT values are appropriate to

expressing internal contamination.

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Commentary – For the ICRP, the advantage of the collec-tive dose is that it can allow optimisation of collectiveexposure to a level that is as low as possible. This value,little used in France, was not included in the Europeanand national regulations.

2 Uncertainties

The values recognised for the various weighting factors(wR and wT) were chosen from a relatively wide range ofvalues. These are approximations designed to provide atool for risk management.

The wR values are taken from physical measurementsdescribing the intensity of ionisation per unit volume, avalue which varies with the residual energy along thepath. When choosing a single value for a given radiation,account is therefore only taken of the direct biological

observations, comparing the effects of this radiation with

those of a reference radiation. Depending on the dose

level and the biological effects considered, the relative

biological effectiveness (RBE) can vary widely.

The wT were also chosen with a view to compromise and

simplification. A few numerical values alone characterise

them. Some are of debatable scientific value. Thus, the

value of 0.2 for the gonads implies the existence of gene-

tic effects which have not been observed and the animal

experimentation data used are probably highly over-

valued. Finally, the breakdown of the risk between the

various organs is primarily the result of epidemiological

observations in Hiroshima and Nagasaki and we do not

know exactly on what bases these risks should be trans-

posed to a human group with significantly different ways

of life.

The effective dose can be used to compare irradiations ofdifferent types, with regard to both the nature of theradiation and whether irradiation is overall or partial.On the other hand, the effective dose comprises a weak-ness: that of not being a measurable value. In the case ofexternal exposure, measurable operational values aredefined (ambient equivalent dose, directional equivalentdose, etc.), which will be used to calculate the dose invariable volumes, according to whether or not the radia-tion is penetrating and according to the effects (dose onthe eye, dose on the skin).

The means of calculating the effective dose also has thedrawback of having varied with time, in line with thechanges made by the ICRP to the wR and wT coefficients,which were reviewed in the light of fresh data as itbecame available. Comparing the effective doses calcu-lated at intervals of several years means that the weight-

ing coefficients used in the calculations must be knownfor each period.

In the case of internal contamination from a long-livedradionuclide, we use the committed dose (committedequivalent dose or committed effective dose). At thetime of contamination, it expresses integration of all thetissue doses, up to complete elimination of the radionu-clide or for 50 years in workers and up to the age of 70in children. The committed effective dose is calculatedusing the dose coefficients of directive 96/29/Euratompublished in France in the order of 1 September 2003defining the methods for calculating effective and equiv-alent doses resulting from exposure of individuals toionising radiation. Radionuclide by radionuclide, thesecoefficients give the effective dose (in sieverts) commit-ted per unit of activity taken in, expressed in bec-querels.

Collective dose and man.sieverts

The collective dose for a given population or group is the sum of the individual doses in a given population; it is obtained bythe formula:

S = ∑ Hi Pi

Hi is the mean of the total doses or the doses in a given organ of the Pi members of the ith subgroup of the population orgroup.

The collective dose unit is the man.sievert.

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APPENDIX 2REGULATION LIMITS AND DOSE LEVELS

Annual limits for the general publicArt. R.1333-8 of the CSP (Public HealthCode)

Worker limits for 12 consecutivemonthsArt. R.231-77 of the CT (Labour Code)

Definition

• Effective doses for the body• Equivalent doses for the lens of the eye• Equivalent doses for the skin (average dose over any

area of 1 cm2 of skin, regardless of the area exposed)

Adults:• Effective doses for the body• Equivalent doses for the hands, forearms, feet and

ankles• Equivalent doses for the skin (average dose over any

area of 1 cm2 of skin, regardless of the area exposed)• Equivalent doses for the lens of the eye

Pregnant women (exposure of the child to be born)

Young people from 16 to 18 years old*:• Effective doses for the body• Equivalent doses for the hands, forearms, feet and

ankles• Equivalent doses for the skin• Equivalent doses for the lens of the eye

Values

1 mSv/year15 mSv/year50 mSv/year

20 mSv500 mSv

500 mSv

150 mSv

1 mSv

6 mSv150 mSv

150 mSv50 mSv

Observation

� These limits comprise the sum of effective or equi-valent doses received as a result of nuclear activi-ties. These are limits that must not be exceeded.

� These limits comprise the sum of effective or equi-valent doses received. These are limits that mustnot be exceeded.

� Exceptional waivers are accepted:• when justified beforehand, they are scheduled in

certain working areas and for a limited period, sub-ject to special authorisation.These individual exposure levels are planned accor-ding to a ceiling limit which is no more than twicethe annual exposure limit value;

• emergency occupational exposure is possible in anemergency situation, in particular to save humanlife.

Annual exposure limits contained in the Public Health Code (CSP) and in the Labour Code (CT)

* Only if covered by waivers, surch as for apprentices.

Diagnostic examinationsDiagnostic reference levelsArticle R.1333-68, order of 16 February2004

Dose constraintArt. R.1333-65, order expected in 2006

RadiotherapyTarget dose levelArt. R.1333-63

Definition

Dose levels for standard diagnostic examinations

Used when exposure offers no direct medical benefit tothe person exposed

Dose necessary for the target organ or tissue (target-organ or target-tissue) during radiotherapy (experimenta-tion)

Values

E.g.: entry level of 0.3mGy for an X-ray ofthe thorax

Observation

� These limits comprise the sum of effective or equi-valent doses received as a result of nuclear activi-ties. These are limits that must not be exceeded.The d iagnost i c re fe rence leve ls , the doseconstraints and the dose target levels are used byapplying the principle of optimisation. They aresimply guidelines.

� The reference levels are defined for standard pa-tients by dose levels for standard radiological exa-minations and by radioactivity levels for radio-phar-maceutical products used in diagnostic nuclearmedicine.

� The dose constraint can be a fraction of a diagnos-tic reference level, in particular for exposure in thecontext of biomedical research or forensic proce-dures.

� The target dose level (specialists talk of a targetvolume in radiotherapy) is used to adjust the equip-ment.

Optimisation levels for patient protection (Public Health Code)

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Lasting exposure (contaminated sites)Art. R.1333-89 of the CSPIRSN Guide 2000

Exposure to radon

Protection of the general publicArt. R.1333-15 and R.1333-16 of theCSP, order of 22 July 2004

Worker protectionArticle R.231-115 of the CT

Enhanced natural exposure (otherthan radon)

Protection of the general publicArt. R.1333-13 and R.1333-14 of the CSPWorker protectionArticle R.231-114 of the CT

Water intended for human consumptionDecree 2001-1220 of 20 December2001, order of 12 May 2004

Foodstuffs (emergency situation)European regulationsCodex alimentarius…

Definition

Selection level: individual dose above which the need forrehabilitation must be examined

Premises open to the public

Working environments

Effective dose

Annual total indicative dose (TID), calculated based onthe radioelements present in the water, except for tritium,potassium 40, radon and daughter products

Tritium

Saleability limits

Values

Not defined

400 Bq/m3

1000 Bq/m3

400 Bq/m3

None

1 mSv/year

0.1 mSv

100 Bq/L

Observation

� The notion of selection level is introduced by theIRSN guide for management of industrial sites potentially contaminated by radioactive materials.

� See recommendation published in Official Gazetteof 11 August 2004 defining the radon measure-ment methods.

� See recommendation published in Official Gazetteof 22 February 2005 defining corrective action tobe taken in the event of an overdose.

� Any population protection action to be taken willbe defined on a case by case basis.

� The TID can be used to estimate the exposure attri-butable to the radiological quality of the water. Anycorrective measures to be taken if the TID is excee-ded depend on the value of the TID and the radioe-lements in question.

� Tritium is a contamination indicator.

See following table.

Action trigger levels (Public Health Code and Labour Code)Activity or dose levels above which action must be taken to reduce exposure

Protection of the general publicIntervention trigger levelsArt. R.1333-80, order of 14 October2003, circular of 10 March 2000

Protection of participantsReference levelsArt. R.1333-86

Definition

Expressed in effective dose (except for iodine), these levels are designed to assist with the relevant responsedecision to protect the population:• sheltering• evacuation• administration of stable iodine (thyroid dose)

These levels are expressed as effective dose:• for the special teams for technical or medical interven-tion

• for the other participants

Values

10 mSv50 mSv100 mSv

100 mSv

10 mSv

Observation

� The préfet can make adjustements to take accountof local factors.

� This level is raised to 300 mSv when the interven-tion is designed to prevent or reduce exposure of alarge number of people.

Intervention trigger levels in cases of radiological emergencies (Public Health Code)

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Consumption restrictions on contaminated food-stuffs

In the event of an accident or any other radiological emer-

gency, the restrictions on the consumption or sale of food-

stuffs are determined in Europe by two regulations:

Council Regulations 3954/87/Euratom of 22 December

1987 laying down maximum permitted levels of radioactive

contamination of foodstuffs and of feedstuffs following a

nuclear accident or in any other case of radiological emer-

gency and Council Regulation 2219/89/EEC of 18 July

1989 on the special conditions for exporting foodstuffs and

feedingstuffs following a nuclear accident or any other case

of radiological emergency. The purpose of these restrictions

is to “safeguard the health of the population while maintai-

ning the unified nature of the market”.

Thus maximum allowable levels in Bq/kg or Bq/L were setaccording to the nature of the radioelement concerned, theproduct concerned and its end-use (baby foods, foodstuffsand feedingstuffs).

A list of foodstuffs said to be of “lesser importance” hasbeen drawn up (foodstuffs which are not consumed inquantities exceeding 10 kg/year). For these items; thyme,garlic, cocoa paste, truffles, caviar, etc., levels ten timeshigher are set.

Foodstuffs or feedingstuffs in which contamination exceedsthese levels, may not be sold or exported. Nonetheless, inthe event of an accident, “automatic” application of this regu-lation may not exceed a period of three months, after whichtime it would be replaced by more specific provisions.

MAXIMUM ALLOWABLE LEVELS Baby Dairy Other LiquidsFOR FOODSTUFFS food foodstuffs intended(Bq/kg or Bq/L) except those for

of lesser consumptionimportance

Isotopes of strontium, in particular 90 Sr 75 125 750 125

Isotopes of iodine, in particular 131 I 150 500 2.000 500

Isotopes of plutonium and alpha-emitting transuranicelements, in particular 239 Pu and 241 Am 1 20 80 20

Any other element with a half-life of more than 10 days, in particular 134Cs and 137Cs 400 1.000 1.250 1.000

Maximum allowable radioactive contamination levelsof feedingstuffs (caesium 134 and caesium 137):Pork: 1.250 Bq/kgPoultry, lamb, veal: 2.500 Bq/kg Others: 2.500 Bq/kg

The WHO also proposed indicative values to facilitateinternational trade. The national authorities may usethese values as the basis for determining their own thre-sholds, thus helping to harmonise these intervention cri-teria.

FOODSTUFFS INTENDED FOR GENERAL CONSUMPTIONPlutonium 238, plutonium 239, plutonium 240, americium 241 10Strontium 90, ruthenium 106, iodine 129, iodine 131, uranium 235 100Sulphur 35, cobalt 60, strontium 89, ruthenium 103, caesium 134, caesium 137, cerium 144, iridum 192 1.000Tritium, carbon 14, technetium 99 10.000

BABY FOODS Plutonium 238, plutonium 239, plutonium 240, americium 241 1Strontium 90, ruthenium 106, iodine 129, iodine 131, uranium 235 100Sulphur 35, cobalt 60, strontium 89, ruthenium 103, caesium 134, caesium 137, cerium 144, iridium 192 1.000Tritium, carbon 14, technetium 99 1.000

Indicative values of the Codex alimentarius for foodstuffs offered for sale in Bq/kg