SYSTEM OF ISSUING AUTHORIZATIONS IN ACCORDANCE WITH THE LAW ON RADIATION AND NUCLEAR SAFETY AND SECURITY

 

Marijana BALIN KOVACEVIC, Snežana ALEMPIJEVIC, Saša BASIC, Ivana BABOVIC and Milan VUJOVIC

Serbian Radiation and Nuclear Safety and Security Directorate

The Law on Radiation and Nuclear Safety and Security (hereinafter: the Law) entered into force on 09 December 2018. The Law introduced innovations in the field of radiation protection, and, as it is partly in accordance with the Council Directive 59/13 EURATOM, it introduced innovations in the system of issuing authorizations for the performance of radiation practices and nuclear activities, which are primarily reflected in the application of graded approach in the categorization and authorization of practices. The Law provides for the system of issuing authorizations for the performance of radiation practices and nuclear activities through the exemption of practices from notification; notification of the intention to perform the practice; the exemption of notified practices from obtaining the authorization, registration and licencing. The Law prescribes the general principles of accountability and the authorization holders’ obligations, as well as the provisions regarding the amendments to, suspension and revocation of authorizations.

  1. Introduction

The Law on Radiation and Nuclear Safety and Security  (hereinafter: The Law) [1] was adopted on the Fourth Sitting of the Second Regular Session of the National Assembly of the Republic of Serbia on 07 December 2018. The Law entered into force on the following day of its publishing in the Official Gazette of RS on 09 December 2018. On the date of entry into force of this Law, the Law on Radiation Protection and Nuclear Safety [2], which had been in force since 23 May 2009, ceased to have effect.

The adoption of the Law meant the establishment of a basis for a new legislative framework in the field of radiation and nuclear safety and security in the Republic of Serbia. The Law, among other things, introduced the new concept based on ordering the line of conduct in the situations of the existing, planned and emergency exposure to ionizing radiation; practice categorization; provided for truly independent regulatory body with wider scope of competences incorporating the inspection as well; and more closely regulated the issues of the security of radiation sources and related facilities and plants.

The enforcement of the La meant that Serbian Radiation Protection and Nuclear Safety Agency, established by the decision of the Government of the Republic of Serbia of 10 September 2009, continued as Serbian Radiation and Nuclear Safety and Security Directorate (hereinafter: the Directorate).

  1. Practice categorization

By applying the graded approach, the Law introduced the categorization of practices according to the risk to the health of the exposed workers and individuals, the public and the environment, as well as the type of practice performed.

The Law divided all practices into the following four categories:

1) Low-risk radiation practices;

2) Moderate-risk radiation practices;

3) High-risk radiation practices;

4) Nuclear activities.

This way, all radiation practices including the use of radiation sources in medicine, veterinary medicine, industry and science and research, as well as trade and transport of radiation sources were divided into three categories. Such division facilitated the instance of defining special conditions for the issuance of authorizations and the performance of practices. These conditions are primarily reflected in the established timeframe for authorization issuance, their validity period and the scope of documents necessary to confirm safety and security of practice performance.

Based on the criteria for the risk assessment of a radiation practice, the Directorate prepared a bylaw [3] closely prescribing the conditions for the categorization of radiation practices, and eliciting the radiation practices and related categories. The categorization criteria, among others, include: the information on the radiation sources and the premises where these are used, the manner of managing the sources, exposure of the workers, the public and the environment, the complexity of the practice performed, radiation protection measures, potential exposure pathways, effluent discharge and RAW generation, assessment of the exposure in case of an emergency and related security measures.

  1. Notification of the intention to perform a practice

A legal entity or an entrepreneur intending to start practice performance is obliged to notify the Directorate before commencing the performance, on which the Directorate issues a relevant certificate.

Holders of the certificate on the notification of the intention are obliged, before commencing the practice, to obtain from the Directorate the authorization in accordance with the practice categorization.

Notified practices can be exempted from the obligation to obtain authorization in line with the requirements closely prescribed by the Directorate.

If the holders of the certificate on the notification of the intention to perform a practice, before the authorization issuance, abandon the intention to perform a practise, they are required to notify the Directorate and the Directorate issues the relevant certificate thereto.

The notification of the intention to perform a practice serves to ensure the insight into the intended use of radiation sources, and to facilitate the import of radiation sources by legal entities or entrepreneurs intending to start with a practice performance for the first time.

  1. Authorization issuance

The obligation to obtain the authorization to perform a practice is prescribed for all legal entities performing the practices regulated by the Law. In addition to licenses that have regulated all radiation practices and nuclear activities so far, the Law introduces a registration as a written document serving to authorize low-risk radiation practices. The license serves to authorize moderate-risk, high-risk radiation practices and nuclear activities.

In accordance with the graded approach, the Directorate has variety of statutory deadlines to decide on applications for the issuance of registrations or licenses. In line with the same principle, and depending on the category, the authorizations have different validity periods. The Table 1 below shows the information on authorization issuance for different radiation practices. These include the type of document authorizing the practice, assumed period of issuance and validity period.

 

Table 1 Authorization issuance for different radiation practices.

Practice category Document authorizing the practice Issuance period* Validity period
Low-risk radiation practices Decision on registration 30 days not limited
Moderate-risk radiation practices Decision on license 60 days 10 years
High-risk radiation practises Decision on license 90 days 5 years
Nuclear activities Decision on license 180 days up to 10 years **

* since the day of dully submitted application

** except in case of licenses for nuclear activity authorization – trial run of a nuclear facility which is issued for a period of two years

 

The Directorate issues the decision on a registration, that is, the decision on a license only after confirming that all requirements prescribed by the Law and the bylaws regulating authorization issuance have been fulfilled. The provisions stemming from the Law on Radiation Protection and Nuclear Safety [4-9] will be applied until the new provisions have been passed. The fulfilment of the requirements for authorization issuance is confirmed by submitting the documentation prescribed by the Law and bylaws. The list of necessary documents can be found in the instructions available on the website of the Directorate [10]. Figure 1 shows the scheme of practice authorization procedure.

The Law also introduced the possibility to amend, suspend or revoke the decision on registration, that is, license issuance at the request of the authorization holder, or based on the inspection findings.

Upon the expiry of a license decision, this can be extended at the request of a licensee. Before extending authorization validity period, and based on the report on periodic review and audit of the Safety Analysis Report, as well as all reported changes in the data on the fulfilment of conditions serving as the basis for license issuance, the Directorate determines if all requirements serving to issue the license, as well as radiation and nuclear safety and security measures have been fulfilled.

  1. Safety Analysis Report and Radiation Protection Programme

The introduction of Safety Analysis Report and Radiation Protection Programme in the authorization issuance helped to improve the design concept of radiation safety and security protection measures for radiation practices and the final report on nuclear safety in case of nuclear activities.

Safety Analysis Report is prepared for a practise performed or intended to be performed, and without exception contains the description of the practice, the description and the features of the premises, facilities, site, and any other location where the practice is performed, the conditions and the limitations for practice performance, safety assessment of the practice performance in normal and abnormal  operations including emergency events, the assessment of assumed initial events that can lead to abnormal operations, as well as potential emergency events and prevention, mitigation and remediation measures in case of an emergency.

The purpose of the Safety Analysis Report is to verify the practise as safe, that is, that its performance guarantees that the exposure of the exposed workers and the public does not exceed the prescribed limits. The safety assessment takes into consideration all exposure pathways and all radiation sources utilized during the practice performance, as well as their interdependence.

The Safety Analysis Report is changed and amended in accordance with the changes arising during the practise performance so that the report in each moment reflects the status of the practise performance. In practise, this means that every change that affects or can affect safety requires changes and amendments to the Safety Analysis Report. This particularly refers to changes in the manner of performing the practise, a radiation source used, requirements for and limitations to the practise performance, as well as the changes on the site, premises or facilities where the practise is performed, etc. In addition to the changes and the amendments to the report resulting from the changes during the practise performance, the Safety Analysis Report is also regularly revised. The report is revised according to the schedule prescribed by the Directorate in the relevant bylaw, or at the request of the Directorate. The revision of the Safety Analysis Report implies its review, verification that the established radiation and nuclear safety and security measures, measures to prevent emergencies and remediation of an emergency event, if applied, ensure both safe and secure practise performance and its upgrade.

The concept of the Initial Safety Analysis Report submitted during the procedure of obtaining the decision on the issuance of license for high-risk radiation practise performance, which the Directorate consents to, is introduced in order to assure that the intended manner of the practise performance, the site, the premises and the facility where the practise is performed, as well as the requirements for and limitations to the practise performance, including the radiation protection measures, are designed and prepared so as to guarantee safe and secure practise performance.

The Radiation Protection Programme comprises all established measures and procedures of radiation protection the authorization holder applies. These measures must include: allocation of duties during practice performance, designation of controlled and supervised areas, establishment of rules for workers and supervision of their work, establishment and implementation of individual monitoring of the exposed workers and the workplace, system of record-keeping and reporting, implementation of radiation protection measures, education and training programme, methods and schedule for periodically reviewing and auditing the performance of the Radiation Protection Programme, plans to be implemented in case of emergency events, health surveillance programme and requirements for the implementation and assurance of quality control.

The Law also introduced the duty of preparing and obtaining consent to Security Plan. The Security Plan that the Ministry of Interior gives its consent to, contains physical protection measures, and other security measures for the radiation sources and related facilities. These measures, among other things, include the description and design of all systems of physical protection, security-related internal documents, and the response plan in case of emergency event. In order to update the security measures regularly, the Security Plan is continuously improved commensurate with all the changes so that in each moment it reflects the status of the facility and the practise.

  1. Conclusion

The adoption of the Law on Radiation and Nuclear Safety and Security also introduced the new concept of issuing authorizations for radiation practices and nuclear activities. By applying the graded approach, the radiation practices are divided into three categories according to their risk. Such categorization is a basis for the establishment of the system of practice authorization. The concept of safety assurance, based on the design of radiation safety and security measures, is improved by the introduction of Safety Analysis Report, Radiation Protection Programme  and Security Plan. The aim of these three documents is to confirm safety and security of a practice.  The regular revision of the Safety Analysis Report and Security Plan ensures continuous monitoring of the practise and the implementation of radiation and nuclear safety and security measures.

It is necessary in the following period to prescribe the requirements for practise performance in detail by adopting the adequate bylaws and further application of the graded approach.

  1. References

 [1]  Law on Radiation and Nuclear Safety and Security (Official Gazette of RS, No. 95/18 and 10/19)

[2]  Law on Radiation Protection and Nuclear Safety (Official Gazette of RS, No. 36/09 and 93/12)

[3]  http://www.srbatom.gov.rs/srbatom/doc/01%20Pravilnik%20o%20kategorizaci ji%20delatnosti%20NACRT.pdf

[4]  Rulebook on Conditions for Obtaining Licence to Perform Nuclear Activity (Official Gazette of RS No. 61/11, 101/16 and 50/18)

[5]  Rulebook on Notification and Registration of Radiation Sources (Official Gazette RS No. 25/11 и 50/18)

[6]  Rulebook on Application of the Radiation Sources in Medicine (Official Gazette RS No.1/12)

[7]  Rulebook on Performance of Nuclear Activities (Official Gazette RS No. 37/11)

[8]  Rulebook on Conditions for Obtaining Licence to Perform Nuclear Activity (Official Gazette RS No.37/11)

[9]  Rulebook on Radioactive Waste Management (Official Gazette RS No. 60/11)

[10]  http://www.srbatom.gov.rs/srbatom/uputstva.htm