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~~("IA~~6T ~~lfJFEDERAL NEGARIT GAZETA
OF THE FEDERAL DEMOCRATIC REPUBLIC OF ETHIOPIA
"P't."t..,.r.: Q(lD.}.cIr,,'CtiE flh..}of-A'.rt..J.'"/,,"rr.~.'I"h,,.I\.rrr./'T'nt\.h 14thYear No 23
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ADDISABABA 220dApril, 2008
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CONTENTS
Proclamation No. 571/2008
Radiation Protection Proclamation ... ...Page 4038
PROCLAMA TION NO. 571/2008
RADIA TIQN PROTECTIONPROCLAMATION -
WHEREAS, the need for using radiation and radio-isotopes in the nations socioeconomic development isincreasing from time to time with the entailing risks ofdamage to health, property and the environment, unlessproper and effective. protection schemes are introducedwith respect to such use;
WHEREAS, it is essential to establish an Authoritythat regulates radiation source~ and related practices inorder to protect individuals, society and environment incurrent and future generation against the harmfuleffects of radiation, while such sources and relatedpractices are used for the benefit of the public;
WHEREAS, it is essential to strengthen radiationprotection activities by defining the legalresponsibilities of persons, who are in charge ofradiation safety and security of radiation sources, andby providing apptopriate sanctions against persons whocause radiation exposure in excess of the acceptablelevel;
lIh.Tr-kJ' t.."..e..~l\lf JtlfPh~ltJ'If tT'fll\.h NOW; THEREFORE, in accordance with Article 55 (I)
,n1 OD'}"1FT h'}~?a :[(; un OolPlT rDIJ.h-tl\m- of the Constitution of the Federal Democratic Republic ofEthiopia, it is hereby proclaimed as follows:
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Federal Negarit Gazeta No. 23 2200 April, 2008 page 4039
PART ONEGENERAL
Short Title
This Proclamation may be cited 'as the "RadiationProtection Proclamation No, 571/2008".
2, Definitions
In this .Proclamation, unless the context otherwisereqUires:
1/ "Radiation" means gamma rays, X-rays,corpuscular, ultraviolet, visible, infrared,microwave or radIo radiation;
21 "Radiation source" means any material ordevice that may cause radiation exposure byemitting radiation;
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31 "Sealed source" means radioactive materialthat is permanently sealed in a capsule orclosely bonded and in a solid form, excludingreactor fuel elements which is not exemptedfrom regulatory control;
41 "Atomic energy" means any type of energyemitted from radio-isotopes, nuclearreactions, nuclear reactors, X-ray equipmentor other technical apparatus emitting ionizingradiation;
51 "Exposure" means exposure to radiation fromsources either external to the body orincorporated within"the body;
61 "Dose limit" means the value of effectivedose or equivalent dose to in,dividuals fromcontrolled practiCes that shall not beexceeded; .
71 c "Practice" means any bum an activity thatintroduces additional sources of exposure orexposure pathways or extends exposure toadditional people or modifies the network ofexposure pathways from existing sources, soas to increase the exposure or the likelihoodof exposure of people or the number ofpeople exposed;
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Federal Negarit Gazeta No.23 2200 April, 2008 page 4040
8/ "Radiation hazard" means any injury or bodilyor mental deficiency or abnormality due toradiation exposure or contamination of theenvironment or property with radioactivematerials;
9/ "Radiation protection" means the task ofprotecting radiation workers and the publicfrom unnecessary exposure by, the accuratemeasurement of radiation and the design anduse of methods to reduce radiation',
10/ "Radiation Worker" means any workerpotentially exposed to radiation as a result ofhis occupation;
III "Radiation work" means work involving theuse of radioactive materials, X-ray equipment
.
or other devices. capable of emittingradiation;
12/ "Exemption" means a determination by theAuthority that a source or practice need notbe subject to some or all aspects of regulatorycontrol on the basis that the exposure due tothe source or practice is small to warrant theapplication of those aspects;
13/ "Exclusion" means any exposure whosemagnitude or likelihood is essentially unableto be controlled through the regulatoryrequirements or standards;
14/ "Radioactive material" means any materialemitting ionizing radiation above theexemption level;
15/ "Notification" means a document submittedto the Authority by a person tq notify anintention to carry out a practice or any otheraction described in the Article 16(1) and 16(2) of this Proclamation;
16/ "Registration" means a form of authorizationgranted by the Authority for practices of lowor moderate risks and accompanied byconditions and limitations as appropriate;
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17/ "License" means an authorization granted bythe Authority on the basis of a safetyassessment and accompanied by specificrequirements and conditions to be compliedwith by the license;
.
18/ "Person" means a natural or juridical person.
19/ "Radiation Safety Officer" means a personwho is a worker of the Authority and inconnection to radiation protection hastechnical knowledge and the propercertificate.
3. Scope of Application
1/ This Proclamation shall be applicable toradiation sources, accessories of radiationdevices and related practices.
2/ The provisions of Sub-Article (1) of thisArticle shall not extend to:
a) radiations and radiation sources found innature without any human interventions;and
b) radiation sources and practices which areexempted from regulatory control.
PART TWO
THE ETHIOPIAN RADIATIONPROTECTION AUTHORITY
4. Establishment
1/ It is hereby re-established the Ethiopian.
Radiation Protection Authority (hereinafter,referred to as "the Authority") as anautonomous federal agency having its ownlegal personality.
2/ The Authority shall be accountable to theEthiopian Science and Technology Agency.
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Federal Negarit Gazeta No. 23 2200 April, 2008 page 4042
5, Head Office
The Authority shall have its head office in AddisAbaba and may establish branch offices in otherregions of the country as appropriate.
6. Objectives of the Authority
The objectives of the Authority shall be to:
1/ protect individuals, the society, its propertyand the environment, in current and futuregenerations, from radiation hazards emittedfrom radiation sources and related practicesincluding X-ray machines above theexempted level; and
2/ carryout or promote study and research onissues that could support radiation protectioractivities.
7. Powers and Duties of the Authority
The Authority shall have powers and duties to:
1/ Issue, renew, suspend and revoke licenses t,perform any of the activities listed in Articl16/1/ and 16/2/ of this Proclamation animpose any necessary conditions on a licensso granted;
2/ Formulate, as necessary, radiation protectiopo licies and draft laws and submit to ttGovernment for approval;
3/ Issue directives for the implementation I
polices and laws concerning radiati{protection and follow up their implementatio
4/ Establish a system for coordinating puband private activities with a view to ensuriradiation safety and security of radiatisources;
.
Render radiation protection services;5/
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Federal Negarit Gazeta No. 23 2200 April, 2008 page 4043
6/ Carryout inspection and take appropriatemeasures to ensure compliance with radiationprotection laws and directives;
7/ Carryout or promote study and research onissues that could support radiation protectionactivities and take measures or advise onmeasures to be takien based on the findingsthereof;
8/ Advise the Government on matters related toatomic energy and radiation;
9/ Organise and promote the dissemination ofinformation on radiation protection andrelated matters through training courses,seminars, pamphlets and the like;
10/ In collaboration with other concerned bodies ,formulate emergency plans and set upemergency squads for accidents involvingradiation and take measures or advise onmeasures to be taken as needed;
11/ Ensure the implementation of treatiesapplicable to the sector and towhich Ethiopiais a party, and cooperate with local, foreignand international organizations having.similar objectives;
12/ Issue directives to define dose limit ,exemption, clearance and exclusion levels aswell as relevant accessory equipments subjectto regulatory control;
13/ Establish a system of national register ofradiation sources and practices;
14/ Issue certificates of competence to thosewho intend to provide radiation protectionrelated services, supervise their activities, andifnecessa.ry suspend and revoke a certificateit issued; and inform, on time, the suspensionor revocation of a certificate to the concernedbodies;
15/ Own property, enter into contracts, sue andbe sued in its own name;
16/ Carryout such other activities as necessaryfor attaining its objectives.
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Federal Negarit Gazeta No. 23 22nd April, 2008 page 4044
8. Or~anization of the Authority
The Authority shall have:1I The Ethiopian Radiation Protection Board
(hereinafter referred to as the "Board");
21 a Director General to be appointed by theGovernment; and
31'Y
The necessary staff.
9. Orflanization of the Board
The board shall be organized by the governmentincluding a senior scientist as deemed necessary.
10. Powers and Duties of the Board
The Board shall have the powers and duties to:
1/ approve, upon submission by the DirectorGeneral, directives, fees and conditions.prescribed for radiation protection activitiesand amendments thereto;
21 review reports and approve the plans, workprogrammes, budget and internal regulationsof the Authority; .
31 receive and decide on appeals by concernedbodies against decisions by the DirectorGeneral;
41 select and appoint. technical advisers andobtain relevant professional assistance onappeal cases submitted to it;
51 Recommend a senior scientist for boardmembership upon request by the government;
61 Provide advices as appropriate on draft lawsto be submitted to the Government as perArticle 7(2) of this Proclamation.
11. ~eetinfls of the Board
1/ The Board shall meet at least once in everysix months;' provided, however, that it mayconvene at any time when called by theChairperson.
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Federal Negarit Gazeta No. 23 22"" April, 2008 page 4045
2/ There shall be a quorum where a simplemajority of the members of the Board arepresent.
3/ Decisions of the Board shall be passed bymajority votes; and in case of a tie, thechairperson shall have a casting vote.
4/ The Board may determine its own rules ofprocedures.
12. Powers and Duties of the Director General
1/ The Director General shall be the chiefexecutive officer of the Authority, andsubject to the general directives of the Board,shall be responsible for its properadministration and operation.
2/. Without prejudice to Sub-Article (1) of thisArticle, the Director General shall:
a) exercise the powers and duties of theAuthority. specified under Article 7 ofthis Proclamation;
b) employ, administer or terminate theemployment of employees of theAuthority in accordance with directivesapproved by the Government followingthe basic principles of the federal civilservice laws;
c) submit reports, plans, work programs,budgets, organizational structure andinternal regulCl;tionsof the Authority tothe Board;
d) effect expenditure in accordance with theapproved budget and work programmeof the Authority;
e) represent the Authority in all its dealingswith third parties;
f) notify the concerned body forthwith incases of radiation accidents andemergencies beyond the means of theAuthority.
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Federal Negarit Gazeta No. 23 2200 April, 2008 page 4046
3/ The Director General may delegate part ofhis powers and duties to the officers andother employees of the Authority to theextent necessary for the efficient execution ofits activities; provided, however, that adelegation given to act 011 behalf of theDirector General for a period of more than 30days, shall be subject to the prior approval ofthe Director General of the Ethiopian Scienceand Technology Agency.
13" Radiation Protection Officers
1/ The Authority shall have radiation protectionofficers to ensure compliance with theprovisions of this Proclamation and otherla~s relating to radiation protection.
2/ Without Prejudice to Sub-Article (1) of thisArticle, a radiation protection officer shallhave the powers to:
a) enter, inspect and examine any businesspremises, vehicle, boat, aircraft or anycarriage, at any time, where he hasreasonable cause to believe that any.source of radiation above the exemptedlevel is held, stored, used, transported ordisposed of without the authorization ofthe Authority, and to seize the source ofradiation found in such process;
b) require the production of any licenseauthorizing the use of radioactivematerial or sources of radiation and anyregistry, notice or document kept inpursuance of radiation protectionlegislation and directives, and to inspect,examine or take a copy thereof;
c) make such enquiries and take sample forexamination as may be necessary toascertain whether the provisions ofradiation protection legislations anddirectives have been complied with andin case of non-compliance, to seal theradiation sources of any institution or theroom in which such sources are located;.
/
d) examine, either alone or in the presenceof any other person as he thinks fit, anyperson with respect to matters under
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radiation protection legislations' anddirectives or.to require such person to beexamined provided that no person shallbe compelled to answer any question orgive any evidence teriding to incriminatehimself;
e) require the conducting of such medicalexaminations as may be necessary in thedischarge of his duties.
3/ Every radiation protection officer shall beprovided with a certificate of authorizationsigned' by the Director General of theAuthority and shall produce the certificatewhere exercising his power under Sub-Article (2) ofthis Article.
14. The Budi!et of the Authority
The Authority shall run its activities by a budgetallocated by the Government.
15. Books of Accounts
1/ The Authority shall keep complete andaccurate books of accounts.
2/ The books of accouns and financial documentsof the Authority shall be audited annually bythe Auditor General or by auditors assignedby him.
PART THREENOTIFICATION AND AUTHORIZATION
16. General
1/ No practice shall be adopted, introduced,conducted, discontinued or ceased except inaccordance with the requirements establishedby the Authority unless the exposure to suchpractice is excluded or the practice isexempted from the requirements, includingthe requirements of notification andauthorization
2/ No radioactive material shall, as applicable,be mined, manufactured constructed,assembled, acquired, transited, imported,exported, distributed, sold, loaned, hired,used, commissioned, maintained, repaired,disassembleQ, transported, stored or disposedof except in accordance with the requirementestablished by the Authority unless the
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Federal Negarit Gazeta No.23 2200 April, 2008 page 4048
exposure to such source is excluded or thesource is exempted from the requirementsincluding the requirements of notification andauthorization.
3/ General notification and authorizationobligations' applicable to non-ionizingradiation sources and related practices as wellas detail regulatory control mechanisms ofthe same shall be determined by regulationsand directives issued hereunder.
17. Notification
1/ Any person intending to engage in any of theactivities described under Article 16(1) and16(2) of this Proclamation or to manufacturestore, import or distribute radiation relatedconsumer products shall submit a writtennotification to the Authority.
2/ Practices arid radiation sources requiring onlynotification shall be determined by theAuthority.
18. Authorization
1/ Unless the practice or the radiation source isexempted or requires only notification as perdirectives issued by the Authority, any personwho engages in a practice or is in possessionof radiation sources prescribed under Article16(1) and 16(2) of this Proclamation shallapply to the Authority for authorization.
2/ No practice shall be authorized unless itproduces sufficient benefit to the exposedindividual or the society to offset theradiation harm it might cause. The applicantfor an authorization shall provide sufficientinformation and evidence on the benefit andharm to support the justification of thepractice.
3/ Any person who applies for a license shall:
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authorized source or practice and otheraccessories necessary to carry outradiation work with the lowestreasonably achievable risk;
b) are given proper instructions on radiationsafety measures and as appropriatereceive medical check up every sixmonths.
3/ The licensee, the radiation safety officer orany"person involved in radiation work, shallnotify the Authority any loss, theft ordiversion for unauthorized use of theradiation source, any over exposure toradiation or the. occurrence of any accidentimmediately or not later than 24 hours aftersuch an occurrence has come to hisknowledge, and fully comply with anyemergency measures as may be prescribed bythe Authority. .
4/ The owner of any radiation source, his agent oremployee shall furnish the means required by aradiation protection officer of the Authority asmay be necessary for entry, inspection,examination, enquiry, the taking of samples orotherwise for the exercise of his duties underthis Proclamation and regulations and directivesissued pursuant to this Proclamation.
5/ Where an individual licensee dies, the personresponsible for the estate shall promptlynotify the Authority of the death of thelicensee and shall ensure the compliance ofradiation protection and safety requirementsas well as the security of the radiation source.
23 Rh!hts of Licensees and other Concernedt)'r. rClt\L:J» p..T2JI7!ODt\b;tTl& fbfr'":f CD1li":f
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1/ An appeal against a decision made by the Authoritypursuant to this Proclamation may be submitted tothe Board within 30 days. from the date ofnotification of the decision. Decisions of theBoard on such appeals shall be final.
2/ In the case of the death of a licensee, theauthorization shall remain valid for three monthsafter the death in so far as it confers the right topossess the authorized radiation source as theestate of the deceased.
24. En2:a2:ement in Radiation Work and MedicalExamination
1/ Any person shall not engage in radiation work if hedoes not have proper training, is under the age of18 years or is not found, by medical examination,
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Federal Negarit Gazeta No: 23 22nd April, 2008 page 4052
to be free from disease or weakness which couldbe considered to make him particularly vulnerableto the health hazards involved in the work.
2/ Any person engaged in radiation'\vork shall,.in addition to the periodic examinationsprescribed in this Proclamation, undergomedical examination as may be required bythe Authority.
3/ The Authority may ban any person who failsto observe the provisions of Sub-Article (2)of this Article from further radiation work.
4/ When a person engaged in radiation work or anyperson who, because of his work, may have beenexposed to ionizing radiation shows signs ofinjury which may be suspected of having been
.caused by such radiation, the. lisencee shall havethe responsibility to immediately make arrangementsfor medical examination of the person.
.
PART FOURMISCELLANEOUS PROVISIONS
25. Confidentialitv
_No person who has obtained confidentialinformation in the course of implementation ofthis Proclamation and regulations and directivesissued pursuant to this Proclamation shall disclosesuch information to any other person unless it isnecessary for the implementation of the Proclamation,regulations or directives.
26. Prohibition
No authorization, other than by the Authority,shall be issued to engage .in any of the activitiesprescribed under Article 16(1) and 16(2) of thisProclamation.
27. Dutv to Cooperate
Any person shall have the duty to cooperate in theimplementation of this Proclamation and regulationsand directives issued pursuant to thisProclamation.
28. Penalties
Unless severe penalties are prescribed in thecriminallaw:-
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Federal Negarit Gazeta No. 23 2200 April, 2008 page 4053
1/ any person who without permission from theAuthority transfers, alters, disposes ordisperses nuclear materials that are likely tocause death or serious injury to any person or.substantial damage to property shall bepunishable with an imprisonment from 3 to15 years or with a fine from Birr 50,000 toBirr 500,000 or with both;
2/ a,ny person who without permission from theAuthority possesses nuclear materials shallb~ punishable with an imprisonment from 1to'3 years orwith a fine from Birr 10,000 toBirr 50,000 or with both;
3/ any person who without permission from theAuthority uses nuclear materials and causedamage shall be punishable with a rigorousimprisonment from 10 to 15 years or with afine from Birr 100,000 to Birr 500,000 orwith both;
4/ any authorized person to use nuclear matenalwho causes damage due to negligence shallbe punishable with a rigorous imprjsom;nentfrom 3 to 10 years or with a fine .from Birr50,000 to Birr 100,000 or with both;
5/ any person Wh9 commits other offences inviolation of the provisions of thisProclamation or regulations or directivesissued pursuant to this Proclamation, shallbe punishable with an imprisonment notbxceeding 3 years or with a fine notexceeding Birr 10,000 or with both.
29. Power to issue Ree:ulations
The Council of Ministers may issue regulationsnecessary for the proper implementation of thisProclamation.
30. Repealed Laws
11 The Radiation Protection Proclamation No.79/1993 is hereby repealed.
2/ No law, regulation or directive shall,.in so far.
as it is inconsistent with this Proclamation,have force or effect with respect to mattersprovided for by this Proclamation.
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31. Eff(fctive Date
This Proclamation shall enter into force uponPublication in the Federal Negarit Gazeta.
Done at Addis Ababa, this 22th day of April, 2008
GIRMA WOLDEGIORGIS
PRESIDENT OF THE FEDERALDEMOCRATIC REPUBLIC OF ETHIOPIA