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Regional Workshop – School for Drafting Regulations

Establishing a Sustainable National Regulatory Infrastructure for Nuclear and Radiation Safety

Development of National System to Regulate Safe Transport of Radioactive Materials in Ukraine

Gorieva Svitlana

Tripaylo Ruslana

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1 - Issuing regulations Governmental, Legal and Regulatory Framework for Safety (GSR – Part 1)

Requirement 1: National policy and strategy for safety•The government shall establish a national policy and strategy for safety…(paras 2.3, 2.4)

Requirement 2: Establishment of a framework for safety•The government shall establish and maintain an appropriate governmental, legal and regulatory framework for safety within which responsibilities are clearly allocated. (paras 2.5, 2.6)•Issuing certificates on approval of designs of packages, radioactive materials, transport, special conditions.

a.What regulations are in force in each case, and

b.What is the review process applied.

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Indicate:

a. Who are the regulators for different modes of transport in your country,

The State Nuclear Regulatory Inspectorate (SNRIU) is the regulator for nuclear and radiation safety for each type of transportation of nuclear and radioactive materials.

• Licensing of the RM transport; • Permissions for international transport of RM;• Issuing conclusions on observing the requirements on nuclear and

radiation safety during RM export, import and transit;• Issuing certificates on approval of designs of packages, radioactive

materials, transport, special conditions.

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b. What regulations are in force in each case, and

Regulation for licensing• Procedure on licensing of separate types of activity in area of nuclear energy

use № 153 (SNRIU 2012 );• Safety Requirements and Conditions (Licensing Conditions) for Implementing

the Activity on Transportation of Radioactive Materials (SNRCU, 2004)• Requirements for Safety Analysis Report on Implementing the Activity on

Transportation of Radioactive Materials (SNRCU, 2004)

General Regulations• Rules on Nuclear and Radiation Safety in Radioactive Materials Transport

(PBPRM-2006) (SNRCU, 2006); • Requirements to Quality Assurance Programs for Transportation of Nuclear

Materials (SNRCU, 2006); • Provisions on Planning of Measures and Actions in Case of Accidents during

Nuclear Materials Transport (SNRCU, 2005); • Procedure of Issuing Certificates on Approval of Designs of Packages and

Radioactive Materials, Special Conditions and Specific Transport (SNRCU, 2007).

• Methodological recommendations for development of Program of radiation protection during transportation of radioactive materials - approved by Order of SNRCU of 02.08.2010 № 101.

• On approval of the Instruction on the Order of the findings of the State Nuclear Regulatory Committee of Ukraine in the international transfer of radioactive material approved by SNRCU Order №138 (2004)

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Regulations for international RM transportation• Procedure for Issuing Permits for International Transportations of

Radioactive Materials - Resolution of the Cabinet of Ministers of Ukraine No.1196 of 03 October 2007;

• “On Approval of the Procedure on Order for Radioactive Materials Transport trough the Territory of Ukraine” - Resolution of the Cabinet of Ministers of Ukraine No.1373 of 15 October 2004;

• Instructions of Order for Submitting Conclusions of the State Nuclear Regulatory Committee of Ukraine during International Transfers of Radioactive Materials (SNRCU, 2004).

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c. What is the review process applied.

The main aim of review process is to assess and control compliance of safety requirement included in the authorization granted in accordance with all Requirements for transport RM

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The Cabinet Ministers of Ukraine Decrees related to the safe transport of RAM:

• On approval of Procedure on licensing of separate types of activity in area of nuclear energy use – 2012 # 153;

• On approval of Procedure and rules of conducting of obligatory insurance of responsibility of subjects of transport of dangerous goods in case of offensive of negative consequences during transport – 2002, # 733;

• On approval of Statute on the Procedure of transport of RAM on the territory of Ukraine – 2004 # 1373;

• On approval of Procedure on the state control on the international transfer of the dual-use goods – 2004, # 86;

• Same question of transport of RAM – 2007, # 1196;

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• Development of the national regulatory framework for transport of radioactive materials was aimed at developing documents that supplement the rules, establish procedures and specify requirements in accordance with IAEA recommendations and practical needs

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Provision on Planning of Measures and Actions for Emergency Response to Transport Accidents Involving Radioactive Material (was issued in 2005)

Requirements for Quality Assurance Programs in Transport of Radioactive Materials (was issued in 2006)

Regulation of Nuclear and Radiation Safety in Transport of

Radioactive Material (PBPRM- 2006)

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Methodological Recommendations for Developing Radiation Protection Programs for the Transport of Radioactive Material (2010)

Procedure for Issuing Certificates for Safe Transport of Radioactive Materials - 2007

Draft

A guide on quality management systems for the safe transport of radioactive materials

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2 - Monitoring of transport operations

To monitor transport operations it is necessary to know the magnitude of the transport in the country. Please indicate:

a. Radioactive materials used in your country

Application of Sources of Ionizing Radiation:

Co-60 – for medical (external beam therapy, brachytherapy), research, industrial (non-destructive control, radiography), metrology

Sr-90 for calibration dosimetry

Cs-137 - for medical ( brachytherapy, irradiator blood ), research (experiments), industrial (non-destructive control, radiography), gauges, ect

Ir-192 – radiography, brachytherapy

Mo-99, Tc-99m, I-131,125 – for medical use only

a. Type and quantity of facilities using radioactive materials

b. Types of packages used

c. Number of packages transported by year

d. More relevant shipments

e. Point of entry, exit, transit routes

f. Who can inspect packages/shipments1. On road

2. At sea ports and on ships

3. At airports and on aircraft

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b. Types of packages useda. Type and quantity of facilities using radioactive materials

• 15 nuclear power units in operation on 4 sites;• Chornobyl NPP site with 3 units permanently shut down and 1

destroyed and covered with Shelter Object;• 2 research reactors;• uranium mines and milling enterprise;• about 3000 medical establishments using radiation sources

(including 52 cancer centres);• more than 2000 enterprises using radiation sources for non-medical

applications;• more than 600 interim confinement points and still on-going

decontamination activities within the Chornobyl exclusion zone.

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b. Types of packages used• Ukraine regulates transportation of fissile and non-fissile radioactive material, of

low and high activity. • 40 companies (consignors and carriers) dealing with transport of nuclear fuel,

uranium ore concentrate, radioactive waste and sources obtained SNRIU licensees.

c.Number of packages transported by year• Annually, from 120 to 150 permits for international transport by road, rail and, in

some cases, water and air transport are issued.

d. Point of entry, exit, transit routesNuclear materials are transported on the basis of international agreements and

uses different point of entry, exit, transit routes

• Russia-Ukraine-Hungary • Russia-Ukraine• Russia-Ukraine-Moldova-Bulgaria • Russia-Ukraine-Slovakia-Czech Republic • Russia-Ukraine-Bulgaria • Russia-Ukraine-Slovakia

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f. Who can inspect packages/shipmentsOn road, At sea ports and on ships, At airports and on aircraft

Custom service and State Environmental Inspectorate

According to this Provision, the SNRIU, besides its main tasks, is assigned to be a competent authority in the field of safe transport of radioactive materials.

Strengthening of institutional and human capabilities of the regulatory authority will also contribute to the safety and security of radioactive materials at all stages of their transport

.During inspections attention inspectors is focused on control of:• Arrangement of physical protection during transport• Appropriate transport documents• Design approvals of the packaging• Limits of the transports indexes of packages and conveyances• Limits of the criticality safety indexes of packages and conveyances• Limits of the nonfixed surface contamination of packages and conveyances• Limits of the dose rate in the distance of 1 m, 2 m from the surface of the packages

and on the surface of the packages• Marking of the packages and of the freight containers• Adequacy of training and knowledge of transport personnel• Emergency preparedness of the personnel• Management system and safety culture

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3 - Import-export of radioactive materials

Transport regulations assume there is an established framework to regulate activities involving radioactive material. As transport is involved in every import/export operation, it is important to know which are the requirements for import/export, e.g.:

•Notifications:– Consignor, Consignee, Dates, routes, final destination

•Certificates– Dangerous goods declaration, Approval certificates for packages /

materials•Inspections

– What inspections are required if any? Who inspects what?

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a. Prepare a detailed list of requirements for import/export of radioactive materials in your country. Include all the organizations involved.

According to the procedure for international transportation of radioactive materials Cabinet of Ministers Decree of 03.10.2007 № 1196

On approval of Procedure on the state control on the international transfer of the dual-use goods – 2004, # 86;

Procedure on licensing of separate types of activity in area of nuclear energy use – 2012 # 153;

The application• Certified copies of the established order of constituent documents (statute or

regulation).• Safety Analysis Report of activities of the transport of radioactive materials.• Information about the qualifications of the personnel of the applicant, to which are

added: Copies of documents confirming the passage of training and testing on nuclear safety, copies of certificates of drivers access to transportation.

• Quality assurance program for the carriage RM.• Emergency plans in case of accidents during transportation of RM.• The program of radiation protection during transportation of RM.• A document confirming the applicant to guarantee compensation for damage which

may be caused as a result of radiation accident during transportation of RM.• Copies of documents (methodology, guidelines) governing the actions of the staff in

the preparation, loading, sending, transportation, transit storage, unloading and receipt at the final destination of the RM and packaging.

• A copy of the authorization to carry out work on IRS issued by territorial authorities of the State Sanitary and Epidemiological Service (included where available).

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4 - Establishing responsibilities

GSR-Part 1, para. 2.5(6)

“…The framework for safety shall set out the following: … (6)Provision for assigning legal responsibility for safety to the persons or organizations responsible for the facilities and activities, and for ensuring the continuity of responsibility where activities are carried out by several persons or organizations successively…”

a.How are the responsibilities established in your country for the transport of radioactive material?

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1.State Nuclear Regulatory Inspectorate of Ukraine – regulatory control of transportation of nuclear and radioactive materials, for licensing of transport, inspection

2.Carrier - responsible for technical condition of transport means and safe transportation

3. State Border Guard Service of Ukraine - exercising border control and allowing passage across the border, according to the established procedure, of individuals, vehicles, cargos and other properties as well as detecting and stopping illegal movement thereof

4. Security Service of Ukraine -special purpose, which provides state security of Ukraine for prevention of terroristic acts and illicit trafficking issues

5. Interior Troops of Ministry of Internal Affairs - for security of transportation including road regulation

6.Ministry of emergency situation - for public protection in case of accidents

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5 - Training and distribution of information

Transport regulations in paras 311 to 314, and GSR Part 1 in Requirement 36, establish provisions for training and communication.•Is the appropriate training available (for all modes of transport)

a. For Consignors

b. For Carriers

c. For First Responders

d. For Radiation Workers

e. For Regulators

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• State System for Physical Protective Education n.J.Kuzmich (Kyiv)• State System for Radiation Safety and Protection Education university

T.Shevchenko (Kyiv)• Training Center for Junior Specialists of the State Border Service of

Ukraine Cherkassy

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6 - Emergency planning and exercises

Transport regulations rely on national provisions to respond to an emergency or incident.

a.Do you have a national response plan?

b.Is response to transport accidents/incidents covered in that?

c.Are the proper authorities involved?

d.Is the appropriate equipment available?

e.Are responders properly trained?

f.Do you have notification requirements?

g.What about members of the public?

h.When was the last emergency exercise for transport?

i.Have you exercised the response plan?

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• Responding to radiation accidents, approved by joint order of the State Nuclear Regulatory Committee of Ukraine and the Ministry of Ukraine of Emergencies and Affairs of Population Protection from the Consequences of Chornobyl Catastrophe of 17.05.2004 № 87/211.

• The order of the interaction of executive and legal entities that carry out activities in the field of nuclear energy, in case of radionuclide sources of ionizing radiation in illicit trafficking, approved by the Cabinet of Ministers of 02.06.2003 № 813.

• Provision for event planning and action in case of accident during the transport of radioactive material (NP 306.6.108-2005). Approved by order of the State Nuclear Regulatory Committee by 07.04.2005. № 38

• Regulation on notification and communication in emergencies, approved by the Cabinet of Ministers of 15.02.99 № 192.

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7 - Compliance assurance and enforcement

SSR-6 requires the competent authority to assure compliance with the regulations (para. 307) and GSR Part 1 requires the establishment of an enforcement policy in cases of non-compliance (Req. 31).

For your country, who is responsible for:

a.Verification of compliance of packages: Documentation, Labelling, Doses

b.Verification of Shipments: Approval, Marking for transport

c.Compliance for carriers

d.Notification: How do you know if an incident has occurred?

Consignor, SNRIU, State border control, State Export Control Service of Ukraine ( for enforcement and regulatory control regulated The Low On civil responsibility for nuclear damage and financial provisions – 2002)

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THANK YOU FOR YOUR ATTENTION