One of the form of state regulation of nuclear and radiological safety in Ukraine is licensing activities in the area of nuclear energy uses carried out by the Nuclear Regulatory Administration which is part of the Ministry for Environmental Protection and Nuclear Safety of Ukraine (Articles 22, 23 of the Law of Ukraine «On the Use of Nuclear Energy and Nuclear Safety»).

Free enterprise is one of the most important condition of reforms in the Ukrainian economy. Nevertheless in some cases the Ukrainian legislation stipulates certain limitations with regard to some types of business activities. The list of such types of activities is established by the Laws of Ukraine «On Enterprise» (Article 4) and «On the Use of Nuclear Energy and Nuclear Safety» (Articles 27 and 28).

As a rule, business activities associated with nuclear energy uses relates to safety when applying dangerous technology processes and to pollution of the environment which poses hazards for the population.

Given this important factor and aiming at safety assurance in nuclear energy uses, a law of Ukraine «On Permission Activities in the Area of Nuclear Energy Uses» has been drafted and is under consideration in Verkhovna Rada (Ukrainian Parliament). The draft law establishes the licensing process regardless of the licensing of business activities.

Licensing of suppliers activities and product certification should be considered separately. These are evaluated by the Nuclear Regulatory Administration as most important elements necessary to achieve the safety of nuclear power facilities. In addition, the report gives a special attention to deliveries to the Ukrainian NPPs by foreign suppliers.

During the period of 1995-1998 some mandatory directions, both legislative and standard-wise, were enacted to define the functions of the state regulatory authority for nuclear and radiological safety (Nuclear Regulatory Administration), the state management authority for nuclear energy uses (Ministry of Energy), operating organizations, NPP management and suppliers in terms of quality of products intended for NPPs. The above-mentioned directions include items as follows:

1. According to Article 21 of the Law of Ukraine «On the Use of Nuclear Energy and Nuclear Safety» the right of determining general conditions and requirements for product supplies is assigned to the state management authority (Ministry of Energy) within the framework of «quality program implementation».

2. In accordance with Article 33 of the Law of Ukraine «On the Use of Nuclear Energy and Nuclear Safety» operating organizations shall establish specific requirements for supplies in contracts and technical specifications based on the general requirements and in the framework of "nuclear safety assurance" and "operation-related activities" .

3. As required by Ukrainian standards and regulations on standardization technical specifications for products affecting the public health and environment (including NPP safety-related equipment) shall be agreed with the regulatory authorities.

4. Certain types of activities associated with supplies, particular works and services shall be carried out only provided a special permit (license) has been granted by the regulatory authority. This is licensing of activities.

5. Safety-related products shall only be allowed to enter nuclear power facilities if a certificate of conformance is available. This is certification of products.

2.1. There is no process of supplies licensing established as such in the state regulatory practices regarding business activities in Ukraine. However, in licensing activities associated with nuclear facilities operation, determining conformance of products to be supplied with standards, rules and regulations in force and their safety implications for nuclear facilities is a mandatory condition. In order to fulfill this requirement what first needs to be done is concurrence of technical specifications with the Nuclear Regulatory Administration. It is recommended that a subcontractor pass this procedure as early as the pre-contract preparation stage in order to exclude delays with or failures to fulfill commitments under a contract.

2.2. Concurrence of technical specifications shall include the following steps:

a) submission of the specifications to the Nuclear Regulatory Administration for preliminary consideration.

During preliminary consideration of documentation the Nuclear Regulatory Administration shall determine:

• the necessity of concurrence of the specifications using product classification as an element important to NPP’s safety;
• the completeness of a document set submitted;
• the necessity of an expert review of technical documentation for compliance with the requirements of valid standards, rules and regulations on nuclear and radiological safety.

The set of documentation shall be sufficient for determining its conformance with:

• technical requirements;
• requirements of valid standards, rules and regulations on nuclear and radiological safety;
• acceptance rules;
• monitoring, testing, analyzing and measurement methods;
• transport and storage conditions;
• operation instructions.

b) acceptance tests of an experimental sample (according to the terminology suggested by the State Committee on Standardization of Ukraine).

The acceptance tests shall be carried out according to the following procedure:

• establish an acceptance commission and define the authorities of either a representative of the Administration or an organization authorized to take part in the acceptance tests;
• consider and agree upon testing programs with the Administration or the authorized organization;
• conduct test and draw up results;
• draw up an acceptance certificate for the experimental sample, get it signed submit a testing report to the Administration.

c) concurrence of the technical specifications.

The technical specifications shall be agreed upon based on:

• the availability of a positive expert conclusion on the set of documents submitted;
• the availability of either the Administration or authorized organization representative’s report on the results of experimental sample testing.

The licensing procedure for a foreign supplier’s activity includes granting a document certifying on behalf of the Nuclear Regulatory Administration that a specific type of activity (such as a product manufacturing and supply) may be pursued by the supplier in accordance with the requirements as established.

Availability of such a document allows operating organizations to conclude contracts for supplies defining both the responsibilities of parties involved and products acceptance requirements (confirmation that products meet the requirements of technical specifications).

In order to be granted a license a foreign supplier shall have a certified quality system meeting the requirements of the ISO 9000 international standard.

The procedure for confirming the quality of products supplied to the NPPs shall be determined by a quality system of the operating organization responsible for NPP’s safety.

In this connection the question of selecting a products certification system lies within the competence of the Ministry of Energy of Ukraine and the National Power Generating Company EnergoAtom.

Best of all justified is using for this purpose mandatory product and supplier quality systems certification procedures within the framework of the existing national system of certification (UkrSEPRO) harmonized with the ISO/MEC certification system.

Today, the Ministry of Energy is working on establishing an industry products certification system for nuclear power facilities.

For this purpose, a decision has been taken and implemented to establish a state enterprise entitled «the State Control Center for Quality of Supplies and Services». The enterprise is accredited with the State Committee on Standardization of Ukraine as a certification body for supplies of products intended for the Ukrainian NPPs. The Center operates in the certification area according to the established procedures of the national certification system UkrSEPRO.

The Center does independent reporting on certification procedures.

V.V. Grishchenko

Deputy Head

Nuclear Regulatory Administration