1. Practice of HOF regulatory oversight E.G. Kudryavtsev Department of Safety Regulation of Nuclear Fuel Cycle Facilities, Marine Nuclear Power Installations and Radiation Hazardous Facilities Rostechnazor, Russian Federation TM on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14-18 December 2015 Federal Environmental, Industrial and Nuclear Supervision Service of Russia 2015

2. 2 Russian Legislative basis for Regulators activity includes: I. Fundamentals of the State Policy in the Field of Nuclear and Radiation Safety of the Russian Federation for the period up to 2025 (approved by the President of the Russian Federation in 2012) II. Federal Laws #170/1995 “On the Use of Atomic Energy” #3/1996 “On Radiation Safety of Population” #7/2002 “On Protection of Environment” #317/2007 “On Rosatom State Corporation” #190/2011 “On Radioactive Waste Management” III. Governmental Decrees #1044/2012 “Federal state supervision in the field of use of atomic energy” #280/2013 on “Provisions on licensing of activities in the field of use of atomic energy” IV. Administrative Regulations, Federal Norms and Rules Federal Environmental, Industrial and Nuclear Supervision Service of Russia

3. 3 Basic Administrative Regulations for Rostechnadzor: Administrative Regulations for the Federal Environmental, Industrial and Nuclear Supervision Service on the implementation of its state function associated with licensing activities in the field of use of atomic energy (order № 453/2014) Administrative Regulations for the Federal Environmental, Industrial and Nuclear Supervision Service to perform its state function of supervising activities in the field of atomic energy use (order № 248/2013) Administrative Regulations for the Federal Environmental, Industrial and Nuclear Supervision Service for issuing permits to nuclear facility employees for activities in the field of atomic energy use (order №721/2011) Federal Environmental, Industrial and Nuclear Supervision Service of Russia

4. 4 3 Nuclear Departments in Rostechnadzor Moscow Headquarter 6 Inter-Territorial Departments (ITD) Siberia and Far East ITD NOVOSIBIRSK Urals ITD EKATERINBURG North-European ITD ST. PETERSBURG Don ITD NOVOVORONEZH MOSCOW Central ITD BALAKOVO Volga ITD

5. 5 Administrative Regulation on licensing lays down the requirements for: the procedure and conditions for licensing activities in the field of atomic energy use distribution of responsibilities between Rostechnadzor’s central and territorial bodies terms of references for safety review the requirements concerning the structure of submitted set of documents justifying nuclear and radiation safety including HOF Federal Environmental, Industrial and Nuclear Supervision Service of Russia

6. 6 Assessment and review of licensee’ set of document justifying safety of nuclear facility/activity includes Analysis of organizational structure of licensee (eg. clear and adequate distribution of responsibilities, establishment of units for radiological protection and control, for engineering service and maintenance, subcontracting of licensed organizations for safety related services) Analysis of amount and qualification of personnel, permission system and qualification upgrade) Adequacy of established defense-in-depth system Compliance with safety requirements, e.g. “General safety provisions for nuclear fuel cycle facilities” (NP-016-05) para 7.2. stipulates organizational requirements for safe operation of the facility para 7.3 stipulates requirements for human factors such as -NFC facility should be provided with properly educated and trained personnel -Special attention should be paid to readiness of personnel adequately react to deviations from normal operation including incidents and accidents Federal Environmental, Industrial and Nuclear Supervision Service of Russia

7. 7 According to federal norms and rules “Requirements for quality assurance programs of nuclear facilities” (NP-090-11): Instructions for certain working positions should include qualification requirements System for personnel preparedness assumes Training / re-training Work on probation Check of knowledge all necessary safety related documents (norms, instructions, regalements, etc.) Examination for obtaining permission to independent work System for personnel training includes Program of annual training and Examination procedure (for licensee under constant supervision the examination commission includes representative from regulatory body) Federal Environmental, Industrial and Nuclear Supervision Service of Russia

8. 8 Oversight of HOF during inspections Regulatory practice in Russia includes different types of inspections: Planned and unplanned inspections Complex inspections (cover all safety related issues including security, accounting of nuclear and radioactive materials, etc.) Inspections in a frame of licensing procedure Programs for inspections are developed by Central Department and routinely includes oversight of human and organizational factors such as Independence of licensee’ managers from governing company Staffing issues (amount of personnel, competence and qualification, efficiency of system for personnel preparedness) Federal Environmental, Industrial and Nuclear Supervision Service of Russia

9. 9 Permits for nuclear facility employees Regulatory practice in Russia includes issuing Permits for employees of nuclear facility directly involved in activities in the field of atomic energy use in accordance with Administrative Regulations: Moscow Headquarter Departments issue permits for top managers of operator: -Director General -Deputies of Director General in charge for technical, nuclear and radiological safety Inter-Territorial Departments issue permits for top managers of Divisions/branches of operator: -Director of separate facility (plant) and his deputies -Head of Nuclear and radiation safety unit, etc. Base for issuing Permits are -Set of documents (including qualification and medical documents) -Result of special exam to confirm knowledge of basic legislative documents and safety requirements based on federal norms and rules Federal Environmental, Industrial and Nuclear Supervision Service of Russia

10. 10 Conclusions In the Russian Federation human and organizational factors are taken into account -according to national legislation and safety requirements -during both licensing procedure and inspections Regulatory oversight of human factor ensures safety of nuclear facilities and/or nuclear activities in terms of minimization of risks connected with quality and training of personnel as a key factor of safety culture Practice of issuing permits for nuclear facility employees might be considered as important factor to ensure safety Oversight of organizational factors should be of key importance for regulatory body during structural and organizational changes in nuclear industry Federal Environmental, Industrial and Nuclear Supervision Service of Russia

11. 11 Thank you for your attention! Federal Environmental, Industrial and Nuclear Supervision Service of Russia