IAEA-TECDOC-644

Guidance on radioactive management legislation for applicationto users of radioactive materials medicine,in research industryand

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INTERNATIONAL ATOMIC ENERGY AGENCY The IAEA does not normally maintain stocks of reports in this series. However, microfiche copies of these reports can be obtained from

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Orders should be accompanied by prepayment of Austrian Schillings 100, for e for e chequa th mf th IAEf m o n i o n i r eAo microfiche service coupons which may be ordered separately from the INIS Clearinghouse. GUIDANC RADIOACTIVN EO E LEGISLATION FOR APPLICATIOO NT USER RADIOACTIVF SO E MATERIAL MEDICINESN I , RESEARC INDUSTRD HAN Y IAEA, VIENNA, 1992 IAEA-TECDOC-644 ISSN 1011-4289

Printed by the IAEA in Austria April 1992 PLEASE BE AWARE THAT MISSINE TH AL F LO G PAGE THIN SI S DOCUMENT WERE ORIGINALLY BLANK FOREWORD bees Iha tn observe y IAEb d A Technical Co-operation experts and advisory missions to developing countries in management and radiation protection, particularly Waste Management Advisory Programme (WAMAP) and Radiation Protection Advisory Team (RAPAT) missions, that there is no uniform approach in the understandin d implementatioan g f radioactivo n e waste management systems - from generation of waste to disposal - in different countries necessars i t I . ensuro yt globaa e l uniformite th n i y approache o findint s g solutione safth e r managemenfo s f o t radioactive . e basith cf o requirement e On n implementini s a gsaf e radioactive waste management regim s thai l countriee al t s should have adequate legislation for managing radioactive wastes. In countries where laws exist, experienced personne e lackinar l o t g implement them, supported by relevant regulations and guidance documents. In many countries the necessary laws and regulatory framework are lacking. It is estimated that there are more than 60 countries having totally insufficient radiation protection and waste management infrastructures which encompass d lawan s regulations that are the basis on which these infrastructures are developed. This is particularly the case in countries which do not have a nuclear power programme, nuclear research reactors or a long experience of work with radiation sources. There is a basic need to improve the situation in this respect.

In 1988 the Waste Management Section of the Division of Nuclear Fuel Cycle and Waste Management prepared a report for discussion on "Guidance on the Requirements for Radioactive Waste Management Legislatio r Applicatiofo n o Usert n f Radioactivo s e Material in Medicine, Research and Industry". The report was meant usete discussioor b dfo obtaid nan n comment IAEf so A staff members and concerned authorities in developing countries. It was prepared by a consultant, Mr.C. Bergman of Sweden, with the assistance of Messrs. O.S. Linsley Rames. ,J , K.T. Thoma E.Ad san . Westerlunf do the IAEA. The report has been extensively used by IAEA staff members in their contacts with developing countrie n IAEi Ad an trainins g courses and workshops. The report was reviewed by Mr. S.D. Soman of India . F.JMr , . Turve r Ireland o y. Pahissa-Camp J . Mr , f o a Lopez-Lizan. ArgentinF . Mr d aan IAEAf ao . Base thein do r comments and development in the field as well as feedback from some countries on the earlier draft, the report has been revised by Mr. K.T. Thomas and is being published as an IAEA-TECDOC to facilitate its further use.

EDITORIAL NOTE

In preparing this material press,the Internationalthe for staffof Atomic Energy Agency have mounted paginatedand originalthe manuscripts givenand some attention presentation.to The views expressed do not necessarily reflect those of the governments of the Member States or organizations under whose auspices manuscriptsthe were produced. thisin The bookuse of particular designations countriesof territoriesor does implynot any judgement by the publisher, the IAEA, as to the legal status of such countries or territories, of their authorities institutions delimitationand the of or theirof boundaries. The mention of specific companies or of their products or brand names does not imply any endorsement or recommendation on the part of the IAEA. CONTENTS

1. INTRODUCTION ...... 7 2. SCOPE ...... 8

3. OUTLINE OF A GENERAL WASTE MANAGEMENT REGIME ...... 8

. WAST4 E MANAGEMENT POLICY ...... 9 .

5. LEGISLATION AND GUIDANCE ON RADIOACTIVE WASTE MANAGEMENT ...... 9 . 5.1. Law ...... 12 5.2. Regulations ...... 14 5.3. Guidance document implementinr fo s g the regulations ...... 5 .1

6. RESOURCES ...... 6 .1 6.1. Financial resources ...... 6 1 . 6.2. Facilities ...... 7 1 . 6.3. Instrumentation and equipment ...... 17 6.4. Manpower and 'know-how' ...... 18

7. SPECIAL COMMENTS ...... 19

REFERENCES ...... 1 .2

ATTACHMEN RADIOACTIVN O GUIDANCW . TA LA A N EO WASTE MANAGEMENT ...... 23

ATTACHMENT B. GUIDANCE ON REGULATIONS FOR RADIOACTIVE WASTE MANAGEMENT ...... 29

REFERENCES TO ATTACHMENTS ...... 41 l. INTRODUCTION

The goal of radioactive waste management is to protect man and s environmenhi t from undue exposur o ionizint e g radiation from radioactive wastes. Thi achieves si wasty db e management practices which comply wit generae hth l radiation protection requirements sa describe n ICRi d P d IAEPublicatioan A ] Basi[1 6 c2 n Safety Standards [2]. Recently the ICRP has adopted new recommendations on radiatio consequenca n s protectioa d an Basie ] eth [3 nc Safety Standards will be revised.

Base n informatioo d n from Member State d experiencean s f o s RAPAT missions, the Agency has already published an internal document on "Radiation Protection Legislation and its Implementation" [4]. It deals with general organization of a radiation protection regime applicabl countrya o et orden I .o rt ensure, however, thae Agencth t s consisteni y n differeni t t documents, the present document is using the same basic approach but with emphasis on questions related to waste management.

Radioactive waste management including disposal pars i ,f o t f radionuclideso e e finaanus th d e l th stet cannoI n i p. e b t justifie itsely db onlbenefitt e parfbu th s usee y a f th f to s o f so radionuclide n medicinei s , researc d industryan h e WastTh .e management legislation mus e seeb t n along wite generath h l radiation protection, atomic energy or other relevant national legislation regulatin f radionuclideo e safe th ge us e th d an s protection of man and his environment from undue exposure to ionizing radiation. Normall wilt yi l suffic speciaa f ei l section wastn o e managemen s includei t sucn i d h legislation o sucn hf I . national legislation exists, it is necessary to create a legislative system covering all aspects of management and disposal of wastes arising from the uses of the radionuclides. No use of radionuclides shoul e permitteb d d unles e radioactivth s e waste arising from such a use can be managed in an acceptable way.

In this documen wastn to e management legislation orden ,i o rt be self contained, many items which already would have been regulate a genera n i d l radiation protection document have been included. For such items therefore, this document should be seen only as a check list as there should not be any contradiction in the legislative details. Further, there should preferably be the same Competent Authorit radiatior yfo n protectio radioactivd nan e waste management.

2. SCOPE

This document, addressed primarily to developing countries, is restricted to management of radioactive wastes arising from uses of radionuclides in medicine, industry and research. It does not deal with wastes fronucleae th m r fuel cycle. Safeguard physicad san l protection are also outside the scope even though in some special e relevantb y casema r instancet fo i ;s , when fissile materias i l handled at research establishments. Information on nuclear fuel cycle waste managemen wastd tan e transpor foun e numbea b n n di t ca r of IAEA publications [5-9].

f thio e maism Th ai ndocumen o givt es i tguidanc n o e legislation require safr dfo e handling, treatment, conditionind gan releas disposar eo radioactivf lo e waste covert I . stepl sal s from the production or import of radioactive material, through use, treatment, storage and transport, to the release or disposal of the waste eithe exemptes a r d materia specian i r lo l repositories.

Management of radioactive wastes as a whole is optimized and kept at acceptable levels in accordance with the basic ICRP recommendation IAEe th A d Basian ] c [1 sSafet y Standards [2]a .s A w ICRne Pe resul recommendationth f to f 199so 1 [3] Agence ,th s i y revisin Basis git c Safety Standards resulte ,th whicf so havy hma e some impacnationae th n to l regulation necessitatd san e updatinf go this document.

3. OUTLINE OF A GENERAL WASTE MANAGEMENT REGIME

Safe waste management practices d theian , r implementation, should be based on: Government policy i.e. to protect man and his environment from undue exposure to ionizing radiation from radioactive waste; legaa l framework i.e., legislatio guidanced nan givo ,t e effect to government policy; the necessary resource o administet s e legislatioth r n i.e. organizational, financial, technica expertised lan .

4. WASTE MANAGEMENT POLICY

There should be a clearly expressed national policy. The objective of the policy should be that adequate protection should environmens hi d ban e n givema t o front m undue exposur ionizino et g radiation from radioactive waste by the application of up-to-date internationally accepted waste managemen disposad tan l methodsn .I establishing and keeping the policy under review, the government shoul e adviseb d y appropriatelb d y qualified persons whose collective expertise covers all relevant disciplines.

5. LEGISLATION AND GUIDANCE ON RADIOACTIVE WASTE MANAGEMENT

In most countries, legislation comprises primary legislation and subordinate legislation, the provisions of which are legally binding. Primary and subordinate legislation is usually supplemented by Guidance documents (which may, for example, be called Codes of Practice) issued by, or under the authority of, the responsible governmental authorities. Such guidance documents give practical recommendations and possible ways in which the specific legal requirements of the primary and subordinate legislation could be met s sucA . h document t specifno o d sy legally binding requirement t sfor no thee mlegislation o th d ypar f e o t ar t bu , valuable supplements to the legislative regime. Any document containing provisions which are legally binding will be a legislative document rather than a guidance one. Fig. 1 illustrate e hierarchth s f o legislativy d an guidance e documentation.

Primary legislation: r easFo y reference, "Primary Legislation" will henceforth be referred to as "the Law". A Law is issued by the supreme law-making authority of the country (e.g. Parliament), provide e legath s l basis for regulating waste management (may be part of a Law Primary legislation (binding)

Subordinate legislation Regulation (binding)

Guidance documents Cod Practicf eo e (not binding)

FIG.Hierarchy1. legislationof guidance.and

on Radiation Protection or Atomic Energy) in conformity with government policy, and normally include generae th s l principle wastf o s e management. alsw La o e authorizeTh issuance Governmensth a y b e- t Minister or other Competent Authority - of subordinate legislation specifyin particulae gth r requiremento st be observed to achieve the general principles of waste management.

Subordinate legislation: r easFo y reference, "subordinate legislation" will hencefort e referreb h s "Regulationsa o t d n som(i "e countries called "Decrees"). These are issued by a Government Ministe r otheo r r Competent Authority specified unde Lawe th r. They establis e generath h l principles (if not already established by the Law referred to above); the waste management strategy and planning; and specify the particular requirements necessary to achieve effective waste management in accordance with the provisions of the Law governing waste management. Regulation normalle sar generaf yo l

10 authorizy ma application w La issuance e eth th t f e,bu o site-specific Regulations. However, even Regulations of general application may authorize the imposition of site-specific condition requirementsd san . Guidance e documentimplementatioth r fo s f o n regulations give instructions and technical details on differene th t part wastf so e managemen complo t y with the regulatory requirements. The normalle yar y issued Competene bth y t Authority.

mannee Th whicn ri h Laws, Regulation Guidancd san e documents are combined to provide an effective regulatory framework for waste management is a matter for the country concerned. This may vary from one country to another depending on its structure, governmental organization, legal tradition d regulatoran s y practices.

In this document no sharp distinction is made between items to be dealt with by the Law and those to be within the Regulations. outlinee Th s which follo merele war y aime coverint da varioue gth s items involved. Furthermore e documenth , t doet maky no san e distinction between what shoul e outlineb d a specia n i d l waste management legislatio describes a n- thin i d s documen whad an t, t- shoul e covereb d n othei d r legislation n generao s l Radiation Protection or Atomic Energy. Most of what is stated, especially in Section 5.1, coul e covereb d generaa n i d l radiation protection legislation.

Normally adoptes i w La d , a followin extensivn a g d formaean l legislative y amendmentprocese subjece an ar th d t i o an st o t s same procedures. Laws are therefore not usually expected to be modified frequentl s thia y s generally require a time-consumins g process. However, Lawd Regulationan s y neema sd amendmena s a t result of changes in the national use of radioactive material, technical development, changes in national waste management policy or evolution ove e rradiatio th tim f o e n protection standardd an s goals. The procedure for issuing and amending Regulations is generally simpler and less time-consuming. Hence, it is advisable to include technical requirements, whic likele subjece hb ar o yt t to frequent change, in the Regulations rather than in the Law.

11 5.1 Law

For the purpose of achieving safe management of radioactive shoulw wasteLa e d, th givbasie eth s for:

o settin e goar protectioth gfo l e workerth e generaf o nth , l public and the environment by: establishing, where appropriatea , multidisciplinary advisory body to assist and advise the Government and the Competent Authority in matters relevant to waste management formulatioe th revied nationana an f wo l policr yo national strateg wastr fo y e management

o establishin Competenga t Authority responsibl regulatorr efo y control and enforcement.

o licensing the following activities involving radioactive material1

production impor expord an t t trade possession handling use treatment/conditioning storage transport disposal

o exempting under proper control and within nationally approved 'exemption1 limits small quantitie f radioactivo s e material waste th parr o e f frot o l managemen al m t regulatory system.

^Base ICRn do P publicatio f 199 o Agency'e 0 1th 6 . nno s Basic Safety Standard beine sar g revised. This revision will have changes in licensing, notificatio d evean nn 'exemption1 whicy ma h necessitate updating the document later.

12 The Law must in addition:

o give all the necessary definitions of terms used in the Law;

o empowe e Competenth r t Authorit o t proposy r o issue e Regulations where appropriate co-operation ,i consultatior no n with other concerned national organizations;

o ves Competene tth t Authority wit righte hth d accesf so an , sto inspection of, premises, facilities and equipment involving radioactive waste to ascertain compliance with the requirements of the legislation;

o set forth penalties or applicable sanctions for violations of Regulationsd an thw eLa .

o allo r appeafo w l against decision e Competens th mad y b e t Authority.

As mentioned earlier, many of the above items in a Law regulating waste management are the same as in a law regulating radiation protectio e appropriatth r o n e nationa w regulatinla l g other use of radioactive material. Further, in a country with a small programme involvin f radioactivo e us g e material, oftee th n same individuals are involved in both use of radioactive material and managemen waste th ef t o arisin g from that use. Thes some ear e e reasonoth f r includinfo s g waste management legislatioa n i n general Law on radiation protection.

There may be other national Laws which can affect waste management. Example sucf so h Laws are: Law regulating environmental pollution Law regulating the working environment Law regulating disposal of hazardous material.

Even though it may not be reasonable or appropriate to draft singla e integrate coverinw dLa aspectl gal wastf so e management, s neverthelesii t s necessar o ensurt y e thae variouth t s laws dealing with waste management are consistent and regulate all aspects of waste management.

13 An example of a text of a generic Law for radioactive waste managemen gives i t Attachmenn i n . tA

5.2 Regulations

Regulations give specific requirement r wastfo s e management accordin e principleth o t gt withi bu e sw th nlai La de th dow n i n limits of the Law. There may be one or more sets of Regulations implementatioe forth Lawe th . f no Preparatio Regulationf no y sma require extensive co-operatio d consultationan n s with other organizations, whic s facilitatei h f theri d e exist n advisora s y body mayt I ., however difficule ,b somn i t e p countrieu t se o t s such an advisory body. In those cases the organization preparing the Regulations must find other means to ensure that the Regulations cover all necessary aspects and do not conflict with other Regulations.

Regulations on waste management should cover the following: o Licensing procedure o Procedure and criteria for 'exempting' waste from further regulatory control o Directives on radiation protection goals and philosophy waste management strategy waste characterization treatment and conditioning monitoring, documentatio reportind nan g transport quality assurance storage emergency preparedness disposal institutional control of disposal sites

Attachmen B tgive s detail f whao s t coul e covereb da n i d regulatory text. It is only an example and depending on the national situation additional paragraph introduce e havb y so ma et d or existing ones modified somn I .e circumstances, some partf so the text coul includee db Lawe th .n di

14 Further information relevan o t Regulationt n o Wasts e Managemen d transporan t e b f foun o wasten t i IAE n dca As publications [6-9].

5.3 Guidance document implementinr sfo regulatione gth s

Guidance documents for the implementation of the Regulations (in some countries called Codes of Practice, Rules or Directives) are not legally binding. They are used by the Competent Authority givo t e recommended detailed operationa technicad lan l standardr so criteria generally applicable to specific practices to ensure that the objectives of the law and regulations are achieved. The Guidance documents wil subjece lb revisiono t amendmentd san s sa a result of changes in the national use of radioactive material, technical developments, change n nationai s l polic d evolutioan y n over tim f nationao e d internationaan l l radiation protection standards, goal policiesd san .

The level of detail in the Guidance documents may vary from country to country. In some countries recommended operational and technical standard r criterio s e Competen th e givear ay b n t Authority on a case by case basis. Such a system however is not generally recommended since even with qualifie d experiencean d d personnel employed by the Competent Authority there is always a risk that uniformly judgin a cas y casn b eo g e basis comparable recommended standards or criteria is often difficult. A general approach should therefore be to have generally applicable technical and operational standards or criteria in the form of written guidance with possibilities for revision or amendments as needs arise. The written guidance need not be very detailed and should e writteb y t than wa sucno i n t a h practical applicatiod an n development of new methods and techniques are made too difficult.

a numbe Ther e f o areaar re s within waste management legislation which cal guidancr lfo their efo r implementation. Some o fe identica b thes e correspondiny th ma e o t l g guidance th r fo e general radiation protection legislation.

Beside iteme sth s discusse 5.2n di , which shoul coveree db n di detaiguidancee th n li , there will als othee ob r items which should

15 be recognized by the Competent Authority such as:

volume reduction principles and methods procedures for dealing with consumer products, liquid scintillation solutions, apparatus with sealed radiation sources, and radium-226 sources used in medicine.

Further information on the subject can be obtained from existing guidance, Codes of Practice and recommendations issued nationally and by international organizations, notably the IAEA, on various aspects of waste management.

6. RESOURCES

Resource e implementatio e needeth ar sr fo d a nationa f o n l waste management legislative regime. Some of the important ones are: financial resources, facilities, equipment, manpower and 'knowhow'. Ther resourcee ear s whic hsame coulshareth r e o e db d wit resourcee hth s neede generaa r dfo l radiation protection regime countrye ith n .

It is not possible to give details on all resources needed in a country since the needs depend on the national situation. In general terms resourcee ,th s shoul adequate db complo et y wite hth waste th requirement er managemenfo p u t sse t regime.

1 Financia6. l resources

The Competent Authority will need, and must have, financial resources in order to function effectively in accordance with the national pla wastr nfo e management resourcee Th .providee b n sca d fronationae mth l budget, from fee wastse paith ey d b producer d san e serviceth user f o ss providee authoritya th y y b b d r o , combination of national budget and fees, depending on national policya significan f I . e tfinancia th par f o t l resources i s provided by the national budget,it should be ensured that the Competent Authorit s i allowey o t functiod n independently irrespective of the quantum of government funding.

16 In most countries e user th ,f radioactiv o s e materiale ar s responsible for the safe management of their radioactive wastes in accordance with the Law and Regulations. Therefore, it is important that such users should have necessarth e y financial resources to do the work. This should be considered in advance whe nradionuclidesf o plannin e us e gth . However State ,th e should ensure by appropriate means availability of funds to deal with abnormal situations when a user due to bankruptcy or for some other reason doe t have financiasno th e l resource tako t s e th car f o e radioactive waste. Otherwise radioactivn i e p materialu d en y sma places where theendangen yca healte rth peoplef ho .

6.2 Facilities

Facilities include buildings, laboratories, and storage installations and waste disposal sites. They should be constructed to comply with the specific requirements, existing or foreseen, of the local or national needs of waste management. The impact on waste management facilities from planned changes in the usf radionuclideseo , notably increased volume f radionuclideo s s used or new application areas, must be analyzed and all necessary modifications or required new facilities must be implemented in a timely manne o complt r y wite changeth h d requirements when they occur. In order to manage short-term increases in waste volumes to be processed, e.gresul a incident n a s .a f to desige ,th n capacity of the facilities should be higher than required for normal operations increasee extene Th th . f to d capacity shoul basee db d n optimizatiooa n f wasto n e treatment methods, efficiencied an s radiation protection. Experience othen i s r countries could give some guidance. It is the responsibility of the user to provide adequate Competene capacityth f o d t,an Authorit ensuro yt e that ti is adequat normalincidente n casa n th i f er o d efo ,an , additional needs of the user.

6.3 Instrumentation and Equipment

The required instruments for implementing a waste management legislative regime should be available. Examples of instruments needed are: surveillance monitors, special radiation detectors, detector activitr sfo y measurements calibratiod ,an n sources.

17 It is the responsibility of the Competent Authority to ensure that the license holders have all the necessary instruments and that it is suitable for the license holder's purpose. For example, in laboratories handling alpha emitting radionuclides, it is not enough to have instruments measuring only beta and gamma radiation. Additional special monitors may be required for weak gamma emitting

radionuclides, ilik aned for weak beta emitters likC e and X4

3H. :L25

The Competent Authority should secur r itsel fo ee bes th ft instruments available, or should have access to them. This does not mean that the most expensive and sophisticated equipment should be procured n mosI .t s preferabli case t i s o havt e e less sophisticated (and cheaper), but reliable instruments which comply witrequiremente hth s needed, since theoftee yar n less sensitive to failure. Also, such factor reads sa y availabilit f servico y e and maintenance facilities are important and should be given due consideration.

The Competent Authority should investigat availabilite eth o yt have acces needef si speciaf do l instrument sneedee b tha , y tdin ma for instance, emergency situations. Examples of such instruments and equipment are: additional radiation protection monitors, shielded transport containers, decontamination equipment, and remote handling devices.

6.4 Manpower and 'know-how1

For the implementation of waste management legislation, it is necessary to have the required manpower with the right combination of education qualification practicad an s l experience. There ar e needs for professionals and technicians at differnet levels an effective combinatio whicf no h should constitut qualifieea d work force; both at the levels of user and Competent Authority. While theoretical expertise is important, practical aspects should be given equal importance. Staff should be capable of tackling problems as they arise which may require approaches both at scientific and practical levels for their solution.

18 A combination of regular training and education of the existin newld gan y recruited staf necessare far maintaio yt welna l functioning team. It is the responsibility of the management to ensure tha personnee tth l hav qualificatione eth s neede perforo dt m their jobs in a safe, efficient and professional manner at all times. This underscores the need for re-training of personnel.

. 7 SPECIAL COMMENTS

o variout e Du s reasons suc s lac a hf wast o k e management legislation, adequate waste management practice or disposal sites, large quantities of waste may be kept under storage in many countries. Often, there may not be proper documentation for the stored e interiwasteth d man s storagn i e e facilitieb t no y ma s accordance with good waste management practice. Such stored waste should be identified, categorized and conditioned in accordance with established international practice.

The process of identification and characterization of unknown radioactive wast complicateds ei includet I . s identificatiof no radionuclides in the waste and measurements of the activity, which often requires sophisticated instruments and qualified expertise.

Countries with such stored unidentified waste, and which do t havno e qualified e expertfiel th f measurino dn i s d an g identifying unidentified radionuclides recommendee ,ar seeo de t kth assistance of the IAEA.

Experience has shown the need for a national register of sealed radiation sources. Such a register can be used by the authorities as a check list for regular control of the sources whic represeny hma rista k resultin serioun gi s health effectsf ,i not handled properly. It is not possible to give exact criteria as to what sources shoul includee db nationaa n di l registero to f I . many source registeree sar d there wil difficultiee lb keepinn si g the register updated. Also, it may cause difficulties in finding quickl e mosth yt hazardous sourcese amonth l listedn o al g f I . other hand, too few sources are included, there is a risk that some sources of significance may have been overlooked from the special contro e recognizeb l n systema guidca s t A i ed. that sealed

19 sources wit activitn ha y contenmose ar t g unlikeltMB below fe wya to give rise to deterministic health effects and further the probability for stochastic effects is reasonably small. On this consideration, national registrie y excludma s ) shor(a e t lived sources, (b) instrument check and calibration sources (other than plutonium containing sources) e responsibilit,th etcs i t .I f yo the national Competent Authority to decide what has to be included. A national register should supplemen replact no d tan e registerd san other documentation which are required to be kept by the users, according to national legislation.

As a rule long lived wastes such as spent radium and caesium sources e dispose shoulb y user b t n thei no di sf o d r premises. They should be handed over to the relevant National Authorities for appropriate long term storage and ultimate disposal according to IAEA guidanc recommendationsd ean .

Procedures for decommissioning and consequent disposal of wastes from large radiation facilities (teletherapy unitd an s industrial irradiation, consumer product manufacturing facilities, etc.) shoul coveree Guidelinese b d th n i d .

The attachments to this report give general guidelines for countrie o develot s d promulgatan p e necessarth e y legislative framewor safr fo ke managemen disposad tan radioactivf lo e wastes.

20 REFERENCES

] INTERNATIONA[1 L COMMISSIO N O RADIOLOGICAN L PROTECTION, Recommendations of the International Commission on Radiological Protection, Publication 26, Annals of the ICRP I 3, Pergamon Press ,Yorw OxforNe k d (1977)an d .

] INTERNATIONA[2 L ATOMIC ENERGY AGENCY, Basic Safety Standardr sfo Radiation Protection, Safety Series No.9, 1982 Edition, IAEA, Vienna (1982). ] INTERNATIONA[3 L COMMISSIO N RADIOLOGICAO N L PROTECTION, 1990 Recommendations of the International Commission on Radiological Protection, Publicatio , Pergamo60 n n Press, Yorw OxforNe k d (1991)an d . [4] WESTERLUND, E.A., IAEA Internal Document on Radiation Protection Legislatio Implementations it d nan , IAEA, RPS-NENS (May 1987) . ] INTERNATIONA[5 L ATOMIC ENERGY AGENCY, Radioactive Waste Management, (Proc. Conf., Seattle, 16-2 y 19830Ma ) Vols 1-5, IAEA, Vienna (1984). ] INTERNATIONA[6 L ATOMIC ENERGY AGENCY, Managemen Radioactivf to e Wastes Produced by Users of Radioactive Materials, Safety Series No.70, IAEA, Vienna (1985). [7] INTERNATIONAL ATOMIC ENERGY AGENCY, Recommendations for the Safe Use and Regulation of Radiation Sources in Industry, Medicine, Research and Teaching, Safety Series No.102, IAEA, Vienna (1990). [8] INTERNATIONAL ATOMIC ENERGY AGENCY, Management of Low and Intermediate Level Radioactive Wastes 1988 (Proc. Symp. Stockholm, 16-20 May 1988) Vols 1-2, IAEA, Vienna (1989). ] INTERNATIONA[9 L ATOMIC ENERGY AGENCY, Regulation Safe th er fo s Transpor f Radioactivo t e Material, 1985 Editio Amendes (A n d 1990), Safety Series No.6, IAEA, Vienna (1990).

21 Attachment A

GUIDANCE ON A LAW ON RADIOACTIVE WASTE MANAGEMENT (See Section 5.1)

GENERAL REMARKS

It is not possible to give a generally applicable text of a regulatinr Lawfo g radioactive waste management. Suc texha t will differ from country to country since it must be in conformity with the national legal tradition and shall also comply with specific national requirement e subjectth n so . Furthermore t shouli , e b d consonancn i r paro f to e with existing general Law Radiation o s n Protection or Atomic Energy.

The following example of legal provisions on radioactive waste management shoul e include b de Nationa th n i d l Atomic Energr o y Radiation Protection Laws. If such Laws do not exist, a separate special Waste Managemen wilw necessarye tLa lb . Howevere th r ,fo sake of completeness, the following example is written as a self-contained text thus including many items which should appear ia Radiation n Protectio r Atomio n c Energ w n whichi La y f i , existence, precludes the need for a special waste management Law. The repetitions should be seen as a checklist.

givew La intende s ni e texe illustrative th b Th f to o dt e only and usee shoulb dt directldno applicatior fo y particulay an n i n r country. A national Law can be drafted with the help of this attachment only after an evaluation of the national situation by the technical authority and in conjunction with the legal authoritie countre th n si y concerned.

23 EXAMPLE OF PROVISIONS TO BE INCLUDED IN A LAW

I. Object

To regulate and control the management of radioactive waste so as to protect man and his environment from undue exposure to ionizing radiation from such waste.

. DefinitionII s

e purpose Law th th e definition r th ,f o eFo e includeb o t s d will reflect national practices e legaTh . l authority responsible for the drafting of the legislation will include all such definitions. Generally speaking, such of those words or phrases (particularly technical words or phrases) whose definitions will facilitate a clear understanding of the Law should be defined. Given below are typical examples (not conclusive) of definitions of some terms that shoul e includedb d r morFo e. information, IAEA Radioactive Waste Managemen d Radiatioan t n Protection Glossaries should be consulted [1] [2].

"radioactive waste management": All activities, administrative and operational, that are involved in the handling, treatment, conditioning, transportation, storage and disposal of waste.

"special waste management facilities": A waste management facilit significana r yo t plana par f to t intende speciaa r fo d l purpose examplr , fo suc s a he interim storage, treatmen r conditionino t f radioactivo g e waste. (Small interim storag d treatmenan e t facilities whice ar h directly connected to a workplace should be covered by the license for use of radionuclides at that work place and should not be subject to separate licensing under the waste management law.)

"radioactive waste": Any material that contains or is contaminated with radionuclide t concentrationa s r radioactivito s y levels greater than the 'exempt' quantities established by the Competent Authorities and for which no use is foreseen.

24 "radioactive material": A material of which one or more constituents exhibit radioactivity, etc.

III. Basic Provisions

Radioactive waste management shall only be conducted in conformity with the requirements of this Law, and with the requirements of other Laws governing radiation protection and those relating to the working environment, environmental protection, transport etc. as specified in the following: ......

IV. Competent Authority

The Minister for ...... is responsible for matters relate o thit d e simplementatio th Law r Fo . f thio n s Lawe ,th Minister shall issue or authorize issue of Regulations and supporting Guidance documents and establish a Competent Authority empowered to carry out supervision and inspection.

Ministee Th authorizy rma existinn e a bod w ne y r gestablisheo d unde issuro t thi w es La Licences , Regulation Guidanced san , specify conditions, and conduct supervision and inspections for the implementation of the Law. This body should be the Competent Authorit r radioactivfo y e waste management. (Whether suca h provision should be included, and the assignment of powers between the Minister and the Competent Authority, will depend on national circumstances. This Attachmen Attachmend tan tshoulB reae db n di the contex thif to s comment.)

Ministee Th establisy rma multidisciplinarha y advisory body to advise and assist the Minister and the Competent Authority in matters relevant to waste management, including formulation and nationae revieth f wo l polic strategr yo wastr yfo e management.

Ministee Competene Th th r (o r t Authority) may regulationy ,b , 'exempt' quantitie ver f slevew o ylo l radioactive material froe mth requirements of this Law. (Such 'exemption' will not necessarily affect the application of any other relevant existing national legislation(s o t radioactiv) e material exempted e froth m requirements of this Law). 25 V. Licences

A Licence is required under this Law for radioactive waste management. The applications to be submitted by the users shall be reviewed and considered by the Competent Authority except for construction of a disposal facility which shall be considered by the Minister or by an Authority designated by him for this purpose.

The Competent Authority may, if it so decides, require licencee a speciao appl t sr fo y l Licence under rfo thiw La s termination and closure of a facility where radioactive wastes have been treated, conditione storedr do .

The licensing procedure shall be as specified in the Regulations.

. ConditionVI Inspectiond an s s

When a licence is issued or during the period of validity of a licence, such conditions may be stipulated as are required from a radiation protection or safety point of view by the Competent Authority.

Supervision and inspection to ensure compliance with this law, regulations or conditions issued pursuant thereto shall be exercise Competene th y db t Authority.

The licence holder shall at the request of the Competent Authority:

give such documents and information as are needed for the supervision allo authorite th w y admittanc e facilitth o t er sit o y e where waste management is conducted to the extent requiresupervisione th r fo d .

VII. Responsibility

The user has the responsibility for management, and for ensuring safe disposal, of all waste generated during and due to

26 radioactive th f o e us e s materialhi . However responsibilite ,th y for disposal could be entrusted to a centralized national authority or facility under the control of the Competent Authority.

VIII. Revocatio Licencef no s

The Competent Authority may revoke a licence if: stipulated conditions or directives have not been observe n somi d e respects whic e essentiaar h r fo l radiation protection or safety ther othee ear r particular radiation protectio safetr no y reasons.

IX. Appeal

Appeal against decision se Ministe e th taketh y r b no r Competent Authority under this law shall be lodged with ...

X. Sanctions

The sanctions for violations of this Law and Regulations issued thereunder and of decisions made by the Competent or National Authority accordin d Regulationan o thit w g La s s issued thereunder shal e stateb l n accordanci d e with national legal traditions and practices taking into consideration the seriousness of the violations and their effects.

27 AttachmentB

GUIDANCE ON REGULATIONS FOR RADIOACTIVE WASTE MANAGEMENT (See Section 5.2)

GENERAL REMARKS

Even if the structure and content of a law may differ from country to country, the law normally only gives the legal basis for detailed Regulations s therefori t I .e necessar o t issuy e Regulation orden i o givw t a rsupplemen la es a se genera th o t l principle d requirementan s s governing waste management. Even Regulation n diffeca s r with regar o structurt d d contentan e A . single regulatio coven wholnca e regulationf o rth t e se area a r ,o s may be issued each covering a limited subject, but together coverin whole gth e als s areai ot I .importan t tha Regulatiota n no radioactive waste managemen conformitn i s ti y with regulationn so radiation protection.

The following exampla regulator f o e y texn wasto t e management writtes ,i singla s na e Regulation, leaving most details of applications to be covered in the guidance documents. It is written as a self-contained document even though many of the items may also be discussed in a corresponding document on radiation protection. Unnecessary duplication excludee b n specifia sca n di c situation where regulation n radiatioo s n protection existe Th . repetitions shoul checklista seee db s na .

The following tex s intendei t e illustrativb o t d e onld an y should not be used as the text of a Regulation for radioactive waste management in any particular country. Such a text can be prepared wit hele hthith f p o s attachment only afte evaluation ra n of the national situation by the technical authorities in conjunction wit e legahth l authoritie countre th n i sy concerned.

29 EXAMPL PROVISIONF EO INCLUDEE B O REGULATIOSA T N DI N

I. Definitions

The following definitions are only examples. Additional definitions may be required according to the national needs. For more information, IAEA Radioactive Waste Management and Radiation Protection Glossaries shoul consultee db ] [2][1 d. applicant e individuaTh : r organizatioo l n that appliea r fo s licenc o perfort e m specified activities with radioactive substances. treatment of waste: Operations intended to improve safety or economy by changing the characteristics of the waste. Three basic treatment concepts are: (a) volume reduction; (b) remova radionuclidef lo s frowastee th m ; (c) chang compositionf eo . collective dose: Collective effective dose equivalent (SE), which is the integrated products of the effective dose equivalent numbee anth d exposef o r d individuals. conditionin wastef go : Those operations that transform waste into a form suitable for transport and/or storage and/or disposal. e operationTh y includma s e convertin e wast th go anothe t e r form, enclosin e wast th gn containersi e d providinan , g additional packaging. disposal: The emplacement of waste in a repository, or at a given location, without the intention of retrieval. Disposal also covers direct discharge of wastes into the environment with subsequent dispersion. individual dose: Effective dose equivalent to an exposed individual.

30 quality assurance: Planne d systematian d c actions aimet a d providing adequate confidence that an item of a facility will perform satisfactorily in service.

storag r interi(o e m storage): Storag f radioactivo e e materials such that: ) isolation(a , monitoring environmental protectio humad nan n contro providede lar d ;an (b) subsequent action involving exemption, treatment, transport and disposal or reprocessing is expected.

II. Licensing Procedure

applicanindividuale n a Th e b y tma organizatio r ,o n (company, institute, etc.)

e applicanTh t shall submi e applicatioth t e nth witl al h relevant informatio competene th o nt t authority. (The regulations should specify the information required to be submitted with the application.)

e applicanTh t shall f requiredi , e suppor,th givd l an al te complementary information needed by the competent authority.

The regulations should also specify the time limits within which actions unde licensine rth g proceduretakene b o t . e sar

Anne thif o xsI attachment gives detail informatiof so e b o nt provided in an application for Licence for import of radionuclides and waste management.

III. Function of the Competent Authority

The Competent Authority shall scrutinize applications and whenever needed require supporting and complementary information. The Competent Authorit issuy yma licencea e subjec conditionso tt , compliee b etc o t . de licensee witth y hb .

The Competent Authority shall give all necessary conditions, instructions or guidance for a given licence.

31 The Competent Authority shall through inspections and reports ensure that waste management activities are performed in accordance with the law and whenever needed, specify complementary or new regulations, condition guidanced san .

e CompetenTh t Authority shall have e premisesaccesth o t s , facilitie equipmend san t license subjecr do licensingo t wels ,a l relevanl al ao st t documentation.

IV. Basic Radiation Protection Principles

The radiation protection philosophy as developed by ICRP [3] and further elaborated by IAEA [4] shall be applicable.

l operationFoal r e followinth s g shal e takeb l n into consideration.

occupational exposure of individuals during waste management

collective doses cause wasty b d e managemen workero t t s and members of the public

individual doses from waste management activities to person criticae th n si l exposee grouth f po d population.

The radioactive waste management system shall be planned simultaneously with plannin activite th f go y generatin wastee gth .

Managemen radioactivf to e waste shal carriee lb without dou t undue suc n delai manneha d yan r tha resultane tth t radiation doses to occupationally exposed persons, to critical groups and to the population as a whole are optimized and kept at acceptable levels in accordance with the basic ICRP recommendations [3] and the IAEA Basic Safety Standards [4]. As a result of the new CRP recommendations published in 1991 [5] the Agency is presently revising its Basic Safety Standards. The result of this revision might have impac nationan to l Regulations. Dose individualo st n si the general public resulting from waste management shall not be more than a fraction of the dose limit given by IAEA in its Basic

32 Safety Standards (some countries have used 1/1acceptabln a s 0a e fraction) maximue Th . m valu thaf eo t fraction shal specifiee lb d by the Competent Authority.

Guideline n implementatioo s w shoulLa e dth takf o ne into consideration emergency preparedness to take care of possible mishaps or accidents and interventions if required at the storage/disposal facilities/sites.

V. Responsibility

It is the responsibility of the waste producer to provide all necessary financial, technical and personnel resources for the safe treatment, conditioning, transport, interim storag disposad ean f lo the waste generated, as well as to ensure the qualification of the personnel involve e work n somth I .n ei d countrie a centras r o l national authority coul responsible b d disposalr efo .

The waste producer may use contractors for implementing different steps in management of the waste. The ultimate responsibility will however remain with the waste producer. (In some countries the government or a governmental organization will be responsibl disposal.r efo )

VI. Characterization, Segregation and Collection

The waste shall be characterized and segregated in such a way facilitatao st e subsequent treatment, conditionin disposald gan .

The waste producer shall set up a system for suitable waste characterization which shal e e b Competenapprovelth y b d t Authority.

The waste producer shall provide the necessary resources for the implementatio e approveth f o n d waste characterizatiod an n segregation system.

Waste shal segregatee lb soos da possibls na e after generation wastee oth f .

33 The waste producer shall provide for and transpor y approveb t d method o suitablt s e interim storagr o e disposal facilities.

VII. Treatment and Conditioning

waste Th e shal treatee l b appropriat n a n di e way propose,s a d usee approved b yth Competenan e r th y b d t Authority:

To separate the waste generated into groups which have similar characteristic d thuan ss facilitate subsequent handlin d treatmentan g e optioTh .f exemptin i n d an g discharging waste streams shoul considerede db .

To reduce the volume of the waste and thus the transport, storag d disposaan e e donb en l ca work t i s lon a ,s a g within the constraints given by optimization of radiation protection and the given dose limits.

o converT waste th t e int chemicaa o d physicalan l form handlede b whic n ca h , store disposer o d f safelo d d an y conveniently.

The treatment method shall be adapted to the aim of the treatment, the subsequent conditioning and disposal methods, the technical and economic resources as well as the personnel qualifications.

Conditionin waste th ef o gshal done b l e with methods giving products compatible wite subsequenth h t transport, storagd an e disposal methods. Only such methods accordancn whici e har e with the national policy shall be used. The conditioned waste form should meet with acceptance criteri e Competenth y ab lait t ou d Authority for interim storage, transport and disposal.

VIII. Transport

All transpor f radioactivo t e waste shal e carrien b li t ou d accordance with the relevant national and international transport regulations IAEe baseth A n dSafeto y Standards "Regulatione th r sfo

34 Safe Transpor Radioactivf to e Materials" [6]. These regulationo sd not apply within establishments where the radioactive waste is generated, use storedr do Competene Th . t Authorit givy yma e rules for transport within the establishment.

. LabellinIX Markind gan g

All radioactive waste shal labellee lb marked dan sucn i d ha way that the origin of the waste, its radionuclides and its activity e contenidentifieb n ca t d durin e entirth g e interim storage period. For waste packages containing long lived radionuclides it may be desirable to have markings which would facilitate identificatio f wasto n e packages ever somfo ne time after disposal, if a decision for retrieval of some waste should late considerede rb .

X. Storage

All radioactive waste awaiting further treatmen disposar to l shal e storeb l d under appropriat d controllean e d conditions. Separated interim storage facilities shal e r b uselfo d unconditioned and conditioned waste. Supervision shall be carried out to the extent deemed necessary by the Competent Authority.

Interim storage of unconditioned radioactive wastes shall be as short as possible and shall not exceed 5 years. During that time wastel ,al s shal conditionee lb disposer (o dexemptes a f do d wastes transferred )an speciaa o dt l waste storage facility. Such a special waste storage may either be a central storage or a local storage of high quality which can guarantee the long-term stability required.

The storage shall be constructed in such a way and operated under such conditions that the waste does not deteriorate during storage to the extent that subsequent safe handling, transport and disposal is endangered.

The waste producer shall e necessarprovidth r fo e y storage facilities complying wite requirementth h s prescribee th y b d Competent Authority.

35 XI. Disposal

Disposal of waste shall be done in such a way that compliance with the general radiation protection principles are achieved. This includes compliance wit ALARe hth A principle.

Disposal options shall be chosen in conformity with the national waste management policy.

Potential disposal options are:

o release to the atmosphere

o discharg th o eet system

o disposa norman o l l municipal

o disposa n shalloi l w land disposal sites intender fo d radioactive waste

In special cases Competene ,th t Authorit demany yma d disposal in deep geological repositories in order to comply with long-term radiological protection requirements.

XII. 'Exempting' Waste from Regulatory Control

The Competent Authority may 'exempt' treatment, conditioning, storage or disposal of radioactive waste from licensing and further control under the law if the wastes have such activity concentration and total activity that the waste presents insignificant radiological hazard.

The Competent Authorit exempy yma t wastes from further control for discharge intsewage oth e system, release atmospheree th o t d , disposa municipaa n lo l landfill reuser ,o basie Th .c principles for exempting radiation source d practicean s s from regulatory contro givee lar IAEn i n A Safety Serie9 [7]8 . .sNo

36 XIII. Documentation and Reporting

The licence holder shall keep documentation to the extent prescribe e Competenth y b d t Authority e documentatioTh . n should compris leastt ea :

Informatio wha n beens o tha n purchased/produced

Up-to-date information on what is in use

Up-to-date information on what is in storage as useful material

Up-to-date information on what is in storage as waste

Up-to-date informatio wha n beens o tha n disposef do into the atmosphere intsewage oth e system or sent for disposal in landfilr lo in special repositories

licence Th e holder shall give regular report Competene th o st t Authority to the extent prescribed. At least annual reports of disposed radioactive materia immediatd lan e report accidentn so r so incidents that have, or may have, resulted in release of radioactive material shal madee lb .

Beside e documentatioth s e nlicenc th kep y b te holdere th , Competent Authority shall kee nationapa l registe sucf ro h sealed sources which, if not properly handled, can give rise to serious health effects. The Competent Authority shall give details on what e includeb e nationa o th it s n i d l registe d whaan rt reporting procedures are to be used.

XIV. Monitoring

All wastdisposee b o et musf do measure e tb monitored dan o dt guarantee compliance with the limits relevant to the disposal route used.

37 waste Th e producer must have instrument equipmenr so t capable of measurin relevane gth t limits applicabl waste th eo e t generated.

XV. Emergency Preparedness

All licence holders handling radioactive material shall establish an emergency preparedness plan specific to the needs of their particular establishmen operationsr to plae Th .n shall also, when appropriate, include provision unplanner sfo d events occurring outside the normal working area; for example during transport.

For users of small amounts of radioactive material, there may be no need for special emergency preparedness outside what is needed for normal radiation protection purposes.

XVI. Quality Assurance

waste Th e producer shall establish working rule controd san l measures, such as to minimize the risk of unintentional discharge of atmosphere wastth sewage o et th r eo systedisposaf o r mo o lt municipal e Competenth , abov y b e limit th tet se s Authority.

waste Th e producer shall establish working rule controd san l measures, such as to ensure that waste packages to be sent for storage or disposal as radioactive waste, are in accordance with the given information (activity content, waste form, qualitf o y waste package etc).

38 Annex I APPLICATIO LICENCR FO N E

Before work with radionuclide startes si radionuclider do e sar imported d befor an ,y othe an e r activity needin a glicenc s i e initiated, an application shall be forwarded to the Competent Authority by the individual or legal person responsible for the waste, import or other activity. Even if it may not be necessary, it is convenient and practical to use standard application forms to ensure that all relevant information is included. Different standard usee differenr formb fo dy sma t applications.

Applications shall contain at least the following information:

Name and address of the natural or legal (company, hospital, research institute, etc.) person responsible th r fo e worapplicatioe th k r fo d nan

Name, position and qualifications of the person with appropriate authority suggested for co-ordinating purchase and stock of radioactive materials and the disposal of wastes.

Description of the work to be carried out in terms used in the legislation (for instance import, sale and transport or waste managemen disposald tan )

- Quantification of the radionuclides

Examples:

(1) 3H, 14C, 32P, 12Si in the form of labelled compounds to be use n biologicai d l research. t Estimateno s i e us d e th eacf o f ho q GB 1 d an C moryear 14 f pe ero q thaMB n1 others.

(2) 1 TBq of e°Co as a sealed source in a GAMMAMAT TI to be usegammr fo d a radiography.

Description of any apparatus containing sealed sources such as thickness gauges, level gauge radiographir so e equipment with

39 copies of any test certificate for the apparatus of above items (certificate approvaf so othen li r countrie alsy sma e o b accepted). These can normally be supplied by the manufacturer. It is strongly recommended to use only apparatu equipmenr o s t whic bees hha n teste approved an d r fo d safe performance. Such testin essentials i g .

For sealed sources the test certificates should show that they meet with ISO or equivalent standards.

- Description of any laboratory and special equipment to be used. Enclosure of drawings may be sufficient.

Number of persons to be involved.

Instruments availabl r measurinfo e g dose rated an s contamination levels contaminatiod ,an n control measures.

Personnel dosimetry procedures.

Description of documentation and record keeping.

Description of storage facilities for the radionuclides and the radioactive wastes preferably supplemente drawingsy b d .

Description of the proposed waste management system, including disposal.

When buying sealed radiation sources, especially when containing radionuclides with long half-lives, it is recommended tha purchase tth e contract include provision reture e th th f r no fo s e suppliesourcth o t e rs spent i onc t i e. f speciao Thi s i s l importance when large sources are used, for example, in medical radiotherapy, gamma radiograph irradiatiod an y n facilities.

40 REFERENCES TO ATTACHMENTS

[1] INTERNATIONAL ATOMIC ENERGY AGENCY, Radioactive Waste Management Glossary, IAEA-TECDOC-447, IAEA, Vienna (1988).

[2] INTERNATIONAL ATOMIC ENERGY AGENCY, Radiation Protection Glossary, Safety Series No. 76, IAEA, Vienna (1986). [3] INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, Recommendations of the International Commission on Radiological Protection, Publicatio Annal, ICRe n26 th PI f so 3, Pergamon Press ,Yorw OxforNe k d (1977)an d .

] INTERNATIONA[4 L ATOMIC ENERGY AGENCY, Basic Safety Standardr sfo Radiation Protection, Safety Series No.9, 1982 Edition, IAEA, Vienna (1982). [5] INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, 1990 Recommendations of the International Commission on Radiological Protection, Publication 60, Pergamon Press, Yorw OxforNe k d (1991)an d . [6] INTERNATIONAL ATOMIC ENERGY AGENCY, Regulations for the Safe Transport of Radioactive Material, 1985 Edition (As Amended 1990), Safety Series No.6, IAEA, Vienna (1990).

] INTERNATIONA[7 L ATOMIC ENERGY AGENCY, Principlee th r fo s Exemption of Radiation Sources and Practices from Regulatory Control, Safety Series No.89, IAEA, Vienna (1988).

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