State Nuclear Regulatory Committee of UkraineState Nuclear Regulatory Committee of UkraineState Nuclear Regulatory Inspectorate of State Nuclear Regulatory Inspectorate of

UkraineUkraine

Safety of radiation sourcesSafety of radiation sources

Unit of Radiation SafetyUnit of Radiation Safety

State Nuclear Regulatory Committee of UkraineState Nuclear Regulatory Committee of Ukraine

LawLaw of Ukraine of Ukraine ««On Use of Nuclear Energy and On Use of Nuclear Energy and Radiation SafetyRadiation Safety»» of 08-Feb-1995 of 08-Feb-1995

Article 22. The State regulation of safe use of nuclear energy envisages:

– Set criteria and requirements (NORMATIVE REGULATION);

– Grant permits/licenses (LICENSING);

– Supervise over compliance with criteria/requirements and licensing conditions, including enforcement (SUPERVISION).

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State Nuclear Regulatory Committee of UkraineState Nuclear Regulatory Committee of Ukraine

Normative Regulation: Normative Regulation: SNRIU area of competence SNRIU area of competence

Sets criteria, requirements, conditions of safe use of nuclear energy;

Develops and approves, within its competence, rules, regulations and standards in the areas of:

– Nuclear and radiation safety;

– Physical protection of nuclear installations (facilities), nuclear materials, radwaste, other sources of ionizing radiation;

Approves, within its competence, drafts of the State and branch standards

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State Nuclear Regulatory Committee of UkraineState Nuclear Regulatory Committee of Ukraine

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Permissive activity in area of radiation Permissive activity in area of radiation sources use - Lawssources use - Laws

• About the use of nuclear energy and radiation safety;• About protection of humans from the influence of ionizing

radiation;• About permissive activity in the field of nuclear energy

use;• On physical protection of nuclear facilities, nuclear

materials, radioactive waste and other radiation sources

State Nuclear Regulatory Committee of UkraineState Nuclear Regulatory Committee of Ukraine

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Permissive activity in area of radiation sources use - Procedures

• Order of licensing of particular activities in the field of nuclear energy use, Resolution of the Cabinet of Ministers # 1782, 06.12.2000;

• Some issues of regulation of activity with radiation sources (RS) (procedure of the state registration of RS), Resolution of the Cabinet of Ministers # 1718, 16.11.2000;

• About ratifying of RS list, use of which is exempted from licensing, Resolution of the Cabinet of Ministers # 912, 01.02.2002;

• About creation of the State register of RS, Resolution of the Cabinet of Ministers # 847, 04.08.97

State Nuclear Regulatory Committee of UkraineState Nuclear Regulatory Committee of Ukraine

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Permissive activity in area of radiation sources use - Procedures

• Procedure for interaction of executive authorities and involved legal entities in case of radioactive sources in illicit trafficking, Resolution of the Cabinet of Ministers #207, 04.03.97;

• Order of determination of level of physical protection of nuclear installations, nuclear materials, radioactive waste, other sources of ionizing radiation in accordance with their category, Resolution of the Cabinet of Ministers # 625, 26.04.2003;

State Nuclear Regulatory Committee of UkraineState Nuclear Regulatory Committee of Ukraine

2012) 7

Permissive activity in area of radiation sources use - Regulations

• “Radiation Safety Standards of Ukraine (NRBU-97)”

NRBU-97 establishes basic principles and criteria's of radiation protection;

• “Basic Sanitary Rules of Radiological Protection of Ukraine” (OSPU-2005).

State Nuclear Regulatory Committee of UkraineState Nuclear Regulatory Committee of Ukraine

2012) 8

Permissive activity in area of radiation sources use - Regulations

• Conditions and rules of RS production (NP 306.4.05/2.046-01);

• Requirements and safety conditions (licensing conditions) of RS use (NP 306.5.05/2.065-02);

• Requirements and safety conditions (licensing conditions) of activity conducting on RS use in radiotherapy;

Acts are harmonized with documents of EC and IAEA, in particular Code of conduct for safety and security of radioactive sources.

State Nuclear Regulatory Committee of UkraineState Nuclear Regulatory Committee of Ukraine

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Permissive activity in area of radiation sources use - Regulations

• Requirements for the safety analysis report of RS production, (NP 306.5.05/2.052-01);

• Requirements to the annual radiation safety analysis report of RS production, (NP 306.5.05/3.055-02);

• Requirements to the safety analysis report of RS use, (NP 306.5.05/2.066-02);

Acts are harmonized with documents of EC and IAEA, in particular Code of conduct for safety and security of radioactive sources.

State Nuclear Regulatory Committee of UkraineState Nuclear Regulatory Committee of Ukraine

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Permissive activity in area of radiation sources use – Regulations

1. Requirements for quality management of diagnostic and therapeutic procedures with using RS, approved by the Order of the SNRCU of 03.10.2008 № 166, registered in the Ministry of Justice of Ukraine as of 29.10.2008 № 1054/15745

2. Requirements and conditions of safety (licensing conditions) on fulfilment of activities with RS in radiotherapy, approved by the Order of the SNRCU of 28.12.2007 № 193, registered in the Ministry of Justice of Ukraine as of 18.01.2008 № 31/14722

3. Requirements and conditions of safety (licensing conditions) on fulfilment of activities with RS in radionuclide radiography, approved by the Order of the SNRCU of 21.09.2010 № 121, registered in the Ministry of Justice of Ukraine as of 20.10.2010 № 950/18245.

4. Requirements and conditions of safety (licensing conditions) on fulfilment of activities with linear accelerators (project 2010 year)

5. The revised document - NP 306.5.101-2004 “Inspection Program of Enterprises, Institutions and Organizations Dealing with Ionizing Radiation”, will be approved by the Order of the SNRCU in December 2010.

State Nuclear Regulatory Committee of UkraineState Nuclear Regulatory Committee of Ukraine

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Radiation sources useRadiation sources use The radiation sources (RS) are used in the different spheres of economic The radiation sources (RS) are used in the different spheres of economic

activity. RS are used in industry, medicine, education, scientific researches.activity. RS are used in industry, medicine, education, scientific researches.

Sphere of use Users quantity

Industry 535

Medicine(without

stomatology)

3112

Science andeducation,

108

Maintenance works

135

промисловість

медицина

наука іосвіта

технічнеобслуговування

Industry

Medicine

Science andEducation

Maintenance works

State Nuclear Regulatory Committee of UkraineState Nuclear Regulatory Committee of Ukraine

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Licensing of activity from the RS use and production

• Activity from the RS use and production belongs to the particular activities in the nuclear energy use and is subject to the obligatory licensing according to

“The order of licensing...” ratified by the decree of Ukraine government.

State Nuclear Regulatory Committee of UkraineState Nuclear Regulatory Committee of Ukraine

2012)

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Licensing of activity from Licensing of activity from the RS use and productionthe RS use and production

• In 2007 primary licensing of medical institutions – users of high-activity RS and primary licensing of non medical users of RS was finished.

• In 2009 primary licensing of activities for RS use and generators production is finished.

State Nuclear Regulatory Committee of UkraineState Nuclear Regulatory Committee of Ukraine

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Permissive activity in area of radiation sources use:

• primary licensing of activities for generators (x-ray equipment) use in radio-diagnostics is continued;

• new radiological facilities (CIBERKNIFE, VARIAN CLINAC) in medicine design is reviewed and assessed;

• more than 7000 RS from bankrupt facilities are transfered to the RAW disposal facilities;

• 5 projects of disused sealed highly-active RS extraction from five facilities to the RAW disposal facilities are developed.

State Nuclear Regulatory Committee of UkraineState Nuclear Regulatory Committee of Ukraine

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The State registration of RSThe State registration of RS

• State Register of RS is computerized state system of accounting and control of RS

• State Register is one of basic countermeasures for radiation accidents and malicious acts with radioactive materials

• From March, 29 , 2007 Register is in operation

State Nuclear Regulatory Committee of UkraineState Nuclear Regulatory Committee of Ukraine

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The RS registration in the State Register of RSThe RS registration in the State Register of RS

• in case of import or export - Customs report to Register

• In case of any transfer of RS - User report to Register

• In case of RS disposal – Disposal Facility reports to Register

Registration of RS in the State Register of RS is checked up during inspections

State Nuclear Regulatory Committee of UkraineState Nuclear Regulatory Committee of Ukraine

2011) 17

Database of RegisterDatabase of Register

• Informative Database of Register includes more than 27 059 records about RS (sealed –13 598, generators - 13461);

State Nuclear Regulatory Committee of UkraineState Nuclear Regulatory Committee of Ukraine

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Priorities in the state safety regulation of the RS use and planned Actions

• improvement of state supervision by strengthening of State Inspectorates for nuclear and radiation safety;

• providing of safe storage of disused high-active RS;• development of new specific requirements for separate

activities with RS (graded approach);• joint activities with Ministry of Health to improve of

radiation protection of patients and creation of Central dose register.

State Nuclear Regulatory Committee of UkraineState Nuclear Regulatory Committee of Ukraine

Thank you for your attention

2012 19