Country Report: INDONESIAIAEA/RCA Mid-term Review Meeting of Focal Persons on Radiation Protection

Beijing, CHINA. 7-11 June 2004

By: Suhartono ZAHIRINDONESIA

BADAN PENGAWAS TENAGA NUKLIR (BAPETEN)NUCLEAR ENERGY REGULATORY AGENCY OF INDONESIA

I. LEGISLATIVE AND REGULATORY FRAMEWORK

1.1. The Legislative Framework

Nuclear Energy Act enacted in 10 April 1997 and promulgated in State Gazette of Republic of Indonesia Year 1997 No. 23 Supplementary State Gazette 3676 contains of elucidation thereto is the principal and primary law governing all related aspects in the use of nuclear energy i.e. institutions, research and development, exploration, regulatory authority, radioactive waste management, liability for nuclear damage, and penal provisions. In order to implement the Act comprehensively requires more detailed, technical, practicable and explainable regulations that become its secondary and derivatives regulations, which include Government Regulations, Presidential Decree and Chairman Decree as the lowest level of regulations. This regime relates with hierarchy of legal system in Indonesia established in People Consultative Assembly No. III/MPR/2000 in which encloses:1. Constitution of Republic of Indonesia;2. Edict of People Consultative Assembly;3. Act, made by in agreement between Parliament and Government;4. Government Regulation (GR) as substitute of Act, ascertained by President under certain

circumstance applicable only 1 (one) Year afterwards they shall be approved by Parliament to be applied to;

5. GR as an Amendment of Act, initiated and drawn up by related Ministerial, Department or Non-Departmental Government Agencies involving a chain of discussion and legal drafting process with related sectors represented in interdepartmental team prior to being signed up by President;

6. Presidential Decree, issued only by President of Republic of Indonesia as Head of Executive Authority;

7. Decree of Ministerial, Departmental Minister or Chairman of Non-departmental Agencies;

8. Local Regulations, made in agreement between Province or District House of Representatives and Head of Province (Governor) or Head of District.

The commitment and concern regarding to nuclear safety and radiation protection assigned by the Act is presented in Article 16 stating that any activity in connection with nuclear energy utilization shall maintain safety, security, peacefulness, and health of the workers, member of the public as well as protection to the environment. This provision is followed-up and implemented through GR No. 63 Year 2000 on Safety and Health against Ionizing Radiation that was enacted on 21 August 2000 and promulgated in State Gazette of Republic of Indonesia Year 2000 No. 136 where Supplementary State Gazette Number 3992 containing its elucidation.

1.2. Radiation Safety Regulation

GR No. 63 Year 2000 covers and adopts all aspect and principles of radiation safety and protection set out in Safety Series No. 120 and BSS 115. It also establishes system of

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radiation safety management, which includes radiation protection organization, dose and radioactivity monitoring, radiation protection apparatus, health examination, record keeping and documentation, quality assurance, and education and training for the workers. In addition to this concern, calibration and emergency preparedness shall be subject to this GR as well as administrative provision in order to put into effect any breach or other non-conformity to the existing law. To put into action this GR operationally, BAPETEN establishes Chairman Decree No. 01/Ka-BAPETEN/V-99 on Occupational Radiation Safety that is still being amended to be harmonized and in line with the requirements and provisions set forth in the BSS 115. Local condition and some adjustment appropriate with the social, economical and legal system in Indonesia are particular factors taken into account in the adoption of such standards.

1.3. Transport and Waste Safety Regulation

In 2002 the government stipulated 2 (two) GRs successively No. 26 Year 2002 on Safe Transport of Radioactive Material and No. 27 Year 2002 on Radioactive Waste Management. GR No. 26 Year 2002 which promulgated in 13 May 2002 in State Gazette of Republic of Indonesia Year 2002 No. 51 where its elucidation is on Supplementary State Gazette No. 4201 constitutes principles of transport safety, exclusion from the scope of this GR, licensing, obligations and responsibilities of related party involving in consignment, packaging, radiation protection program, training and education for radiation workers, quality assurance program, type and activity limit of radioactive material, radioactive material containing other hazardous substance, and emergency preparedness. This GR is also implementing Article 16 of the Act where the primary of objective of such stipulation is to protect and ensure the safety, security, peacefulness, and health of the workers, member of the public, as well as environmentally sound. As applied to all aforementioned regulations, this GR has its own derivative that is Chairman Decree No. 04/Ka-BAPETEN/V-99 on Safety Provisions of Transport of Radioactive Material that was made on the basis of Safety Series No. 6 and it is planned to be revised with the intention of TSR-1 since this GR has concluded principles within such standards. The important decree elucidating this GR is also BAPETEN Chairman Decree No. 05-P/Ka-BAPETEN/VII-00 on Guidance for the Fulfillment of Safe Transport of Radioactive Material that still adopting Safety Series No. 88. This Decree will be revised too in near time.

In the radioactive waste management auspices, Indonesia has enacted GR No. 27 Year 2002 as the application of Article 27 of the Act that entails further arrangement of the subject matter in particular GR. This GR promulgated in 13 May 2002 in State Gazette of Republic of Indonesia Year 2002 No. 52 where its elucidation is on Supplementary State Gazette No. 4202 comprises of classification of radioactive waste, licensing management, responsibilities of Promotional Body, obligations and responsibilities of waste generators (the holder of license), the arrangement of radioactive waste originating from abroad, management of spent nuclear fuel, radioactive waste treatment, transport, and storage, of quality assurance program, environmental management and monitoring, treatment of waste from nuclear ores and other conventional ores mining, of decommissioning program, emergency preparedness, administrative an penal provisions. Radioactive waste management

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provided in this GR is relevant with the fundamental principles as set forth in Safety Series No. 111-F in addition to the application of radiation protection principles as mentioned in Article 3 of this GR which are justification, limitation an optimization. Article 7 says that prior to obtaining license, any legal person or entity shall submit notification to the Regulatory Body whether the radioactive waste produced will be returned to the original countries or be submitted to the Promotional Body as the sole national authority to undertake management of such waste. For the intention of returning waste they shall obtain approval from Regulatory Body in advance. For the sake of safe management of spent nuclear fuel, this GR determines that waste generators (licensee) shall not be allowed to reprocess such waste nonetheless the licensees shall put the waste into interim storage during the reactor operation lifetime, afterwards they submit such waste to the Promotional Body for final repository emplacement or return the waste back to the original countries. To anticipate and to handle NORM and TENORM rise from mining and milling of natural ores, this GRs covers in Article 31 and 32 therein declare the following points:a. Promotional Body or any entity deemed to carry out nuclear ore mining shall collect,

classify, or treat and dispose of temporarily the radioactive waste produced therein.b. Any legal person or entity intended to carry out non-nuclear ore mining containing

radioactive waste as its tailing or byproducts shall perform radiation safety analysis and submit the report to the Regulatory Body.

1.4. Emergency Regulations

Within the national regulatory infrastructure, there is no special Act or GRs governing Emergency Preparedness and Response or Emergency Plans. However, GR No. 63 Year 2000 in chapter VI stipulates the emergency preparedness of radiation accident. There are 4 Articles (Article 32-35) governing the emergency aspects in the chapter. In Article 32 is stated that the user shall have an effort to prevent any radiation accident. Article 33 governs the obligation of user to take emergency response when any accident happens, the safety of human is the first priority in the concept of emergency response, and the user shall report for the accident to the Regulatory Authority and also other related institutions or organizations. Article 34 declares that the user utilizing the higher potential hazards of radiation installation shall submit the Emergency Plans to the Regulatory Authority for approval.

In addition, Nuclear Energy Regulatory Agency has issued the Chairman Decree No. 05-P/I-03 on the Guide of Emergency Preparedness and Response. It applies for all types of nuclear and radiation installations. The decree governs the guidance for user how to prepare the emergency plans and the content of emergency plans and also categorization of nuclear emergency preparedness based on the potential hazards.

1.5. Regulatory Authority Organization, Staffing and Funding

Research and development in the use of nuclear energy in Indonesia have led to a wide scale application in research, and development in the use of nuclear energy in Indonesia have led to a wide scale application in research, medicine, industry, agriculture, and

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veterinary. Those may contribute associated risks that endanger and threaten safety and health of the workers and member of the public as well as the sustainability and protection of the environment. These activities need to be controlled by an effective and independent Regulatory Authority.

Nuclear Energy Regulatory Agency denoted henceforth BAPETEN (Badan Pengawas Tenaga Nuklir) was founded in 1998 on the basis of Nuclear Energy Act No. 10 Year 1997 which dissolved and separated the former National Atomic Energy Agency (BATAN – Badan Tenaga Atom Nasional) then designated BAPETEN as Regulatory Body and BATAN as Promotional Body. The separation settled on the Act was a significant measure where averting the occurrence of conflict of interest between promotional task for research and development in nuclear energy and the control task of nuclear energy utilization taken into consideration and this provision distinguishes it from the previous Atomic Energy Act No. 31 Year 1964. The former Atomic Energy Act stated that the control of nuclear energy use was authorized and responsibility of a small bureau inside BATAN. However in the implementation of the performance of nuclear energy utilization control became low priority and this condition may have jeopardized with safety, health and security.

The establishment of BAPETEN set forth in the current Act is concordant with the applicable international standard particularly IAEA Basic Safety Standards – 115 and duly as mentioned in Nuclear Safety Convention that has been ratified by Government of Republic of Indonesia by means of Presidential Decree no. 106 Year 2001. Those documents call for and recommend the notable roles and the need of independent regulatory authority existence to control any nuclear energy related activities.

With reference to Article 14 of Act No. 10, BAPETEN is empowered to control any nuclear energy utilization through regulations, licensing, and inspection. In conducting its tasks, as one of non-departmental government agencies, BAPETEN is under and directly responsible to the President of Republic of Indonesia pursuant to Presidential decree No. 76 Year 1998 as revised and amended latest by Presidential Decree No. 103 Year 2001 on Status, Function, Authority, Form and Organization Structure of Non-Departmental Government Agencies.

In connection with the main task of BAPETEN, furthermore in Article 15 of the Act sets out the objectives of controlling nuclear energy use which are:a. to assure the welfare, security and peacefulness of all people;b. to assure safety and health of workers, member of the public as well as protection of the

environment;c. to maintain legal order in the application of nuclear energy utilization;d. to promote legal consciousness of nuclear energy users to develop safety culture in the

field of nuclear energy;e. to prevent the diversion of nuclear material utilization;f. to assure the maintained and improved discipline of workers involving in the

application of nuclear energy utilization.

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BAPETEN authorizes to recruit its employees based on professionalism and particular fields of knowledge and scientific background required in each division in regard with regulations draft-making and analysis, evaluation and assessment of license documents, and with performance of inspection. The President of Republic of Indonesia designates and appoints Chairman of BAPETEN and the Chairman has his privilege to select the rest of staffs, direct and run BAPETEN in the conformity of applicable laws. BAPETEN as one of the governmental agencies attains financial support from annual national budgetary and expenditures to proceed its institutional tasks assigned by law and operational administration therein. The organizational chart of BAPETEN based on Chairman Decree No. 01.re.1/K-OTK/Ka-BAPETEN/II-01 on Organization and tasks of BAPETEN is implied on Attachment 1. Conducting its tasks, BAPETEN receives the budget from the government.

1.6. Co-ordination and co-operation at the national level

BAPETEN has been established the co-ordination and co-operation with the other related institutions or organizations either government or private. To achieve effective and efficient regulatory control on the utilization of nuclear energy, there are some memoranda of understanding developed by BAPETEN and other organizations or ministries. For example, in the field of nuclear energy utilization, it has been signed the memorandum of understanding which is stated the co-ordination and co-operation of nuclear technology between BAPETEN and the National Nuclear Energy Agency. To increase the professionalism of BAPETEN’s staff, it has been also established the close co-operation with some universities in providing training and education. The other objective of the co-operation is also to exchange information.

1.7. International Cooperation

To achieve the goal of the regulatory control of nuclear energy utilization, BAPETEN needs to develop the co-operation with the regulatory bodies of other States and with international organizations. The type of most international co-operations is technical co-operations including technical training and scientific visits. BAPETEN obtains many technical assistance and advice in the form of missions from the Atomic Energy Agency. Almost every Year, BAPETEN has been provided the training courses, scientific visits and expert missions and also some technical documents. The regulatory authorities from other states co-operated with BAPETEN are Nuclear Regulatory Commission of USA, the KINS-Korea, the MITI-Japan, and others.

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II. ACTIVITIVIES OF THE REGULATORY AUTHORITY

2.1. Notification and authorization system

One aspect of control of nuclear energy utilization is licensing procedures. Paragraph (1) Article 17 of Act No. 10 Year 1997 determines that any activities related to nuclear energy utilization shall be consent to license, regardless of particular condition shall be subject to exemption that further be settled on GR. Paragraph (2) sets up that construction and operation of nuclear reactor and other nuclear installations including decommissioning of nuclear reactor shall authorize license. Bearing in mind the mandatory clause exists in the first Paragraph of Article 17, in 1999 BAPETEN proposed to the President draft of GR pertaining to the subject, which later on revealed as GR No. 64 Year 2000 on Licensing of Nuclear Energy Utilization that was signed and enacted on 21 August 2000 then promulgated in State Gazette of Republic of Indonesia Year 2000 No. 137 where Supplementary State Gazette Number 3993 containing its elucidation. This GR is intended only for licensing process of any practice relating to the use of radioactive material, radiation sources and nuclear material, which encompasses requirements and general procedures to obtain license, compulsory and responsibilities of licensee, administrative provisions, and inspection.

BAPETEN has been issued 3 licenses for research reactors and some supporting installations, 2 licenses of non-commercial irradiators and a license of commercial of irradiator, more than two thousands licenses of medical, industrial and research facilities utilizing the nuclear energy.

2.2. Inventory of Sources

Data on radiation sources and radioactive materials used in the radiation and nuclear installations have been obtained and controlled by the licensing processes and inspection activities. A license issued by the BAPETEN contains the type and number of radiation sources and or radioactive materials used for the each utilization, therefore BAPETEN can obtain the inventory of sources from the data in the issued licenses. The Inspector of BAPETEN conducts the inspection to the nuclear or radiation installation to verify the accurateness of data of inventory sources such as the type and number and other characteristics of sources including the appropriateness of facilities and radiation protection equipment for handling the sources. BAPETEN has not had other special activity for controlling the inventory of sources.

2.3. Inspection and Review

Inspection as governed inside the GR No. 64 Year 2000 pursuant to Article 20 of the Act orders to BAPETEN to undertake inspection to any nuclear installations and radiation facilities in order to ensure the compliance to license requirements and conditions as well as applicable law in the area of nuclear safety. BAPETEN has its own right to assign inspectors

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based on qualifications and even to discharge them. According to this GR inspection shall be performed periodically or timely with or without notification. Inspectors as referred to in Article 13 of this GR have their tasks and authority to go into any installations and premises where sources are used or stored, to perform inspection during evaluation of license application, to undertake radiation monitoring, and to terminate any practice whenever emergency condition which could lead to radiation hazard should occur. BAPETEN carries out nuclear and or radiation inspections to average 200 installations annually. For an emergency situation, BAPETEN takes an action to inspect as soon as possible after it has been reported by the user.

2.4. Enforcement

Act No. 10 Year 1997 has specified the availability of penalties for serious non-compliance (maximum monetary penalties and maximum prison sentence). For example, based on the Article 43 when the radiation installation has not had a license, it is subject to the fine of maximum of a hundred millions rupiahs. According to the GRs, to take actions to any breach offence, violence, and non-compliance committed by user or licensees, BAPETEN is authorized to deliver administrative sanctions initiated with written notification/warning and halted with revocation and/or suspension of the license and termination of operation of such installations/facilities which provided in accordance with the implication and influences may cause and the offence degree entitled thereof. In addition to such measure, BAPETEN may proceed particular breach, offence, and non-compliance contravening the Act and its derivatives to the criminal court. Enforcement of those regulations shall not be done solely by BAPETEN according to penal legal system in Indonesia. This action shall involve also other institutions concerned namely police department, public prosecutors, and judges.

Until now, BAPETEN frequently enforces some users especially medical installations with finding from the inspection activities by the written notification/warning. BAPETEN has an effort to advise them to take corrective actions in fulfilling the licensing requirements.

2.5. Assessment and verification of operational radiation protection programs

BAPETEN has a special center in charge of the assessment and verification of operational radiation protection programs. The center provides a number of inputs needed for a technical judgment in conducting regulatory activities, such as regulation drafting, licensing process and inspection activities. The staffs of center are doing researches by themselves to support the assessment and verifications in supporting the implementation of regulatory process.

2.6. Safety and security of sources

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In controlling the safety and security of sources, BAPETEN has applied the strict licensing requirements like the requirement of qualified workers in handling the sources, the requirement of the adequate facilities including interim storage facility, the requirement of appropriate radiation protection equipment or tools and the requirement of available procedures. For the security of sources, there is no special regulation published by BAPETEN. During this Year BAPETEN has taken into account detail legal drafting on the security of sources. Besides that, BAPETEN has also been carrying out some seminar and or workshops on security of sources to obtain technical input from stakeholders. In co-operation with the Department of Energy – USA, BAPETEN has been doing the proactive activities to assist the users in facilitating the security equipment and or infrastructure.

2.7. Control of orphan sources

Until now, all applied nuclear regulations have not required yet the specified clear actions to control the orphan sources, including the requirement for user in reporting to BAPETEN when there is an orphan source within its installation. However, BAPETEN is doing the action plans to regulate the orphan sources.

2.8. Technical services availability

Sometimes, BAPETEN, as a government authority who has one function to co-ordinate the national nuclear legal infrastructure in the close-relationship with other institutions or organizations, has also been participating in the task of establishment of the rules and regulations from other related government institutions or ministries. BAPETEN frequently undertakes the consultant or educates or instructs a number of radiation workers provided by the other government organizations or non-government bodies.

2.9. Communication with the public

According to the Article 21 of the Act No. 10/1997, BAPETEN provides the guidance and counseling on the implementation of efforts to the health and safety of radiation workers, and member of the public, as well as environmental protection. Annually, BAPETEN carries out the socialization on the regulations or rules which will be applied for the user around the country. BAPETEN also provides the information of regulatory activities electronically and in print. From the communication, BAPETEN has involved the member of public in doing the functions; therefore the quality of regulatory product will be continuously increased.

2.10. Quality management systems

BAPETEN established “Quality Assurance Program of BAPETEN Rev 0.0” in March 23rd, 2001. This is a Level-1 document that formulates quality management system of

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BAPETEN. Currently, the document is being updated. Final Draft of Revision 1.0 is adopting widely from the IAEA-TECDOC-1090 “Quality assurance within regulatory bodies.” (June, 1999). Management procedures of rulemaking, licensing and inspection, and assessment manuals are available. All of these documents are guideline to realize systematic and planned activities to ensure an effective and efficient regulatory program for radiation protection and the safety of radiation sources. The documents also identify all BAPETEN stakeholders to make it possible for an effective and efficient coordination and or supervision.

III. CONTROL OF OCCUPATIONAL EXPOSURE

3.1. Individual monitoring for external radiation

Dosimetry services available and their status in Indonesia are as follow:

No Institution Accreditation status Types of Dosimeter1. Laboratory of Safety, Health, and

Environment, CRSNB-BATAN.Pasar Jumat Facility, Jakarta.

Accredited by independent National Accreditation Commission (KAN)

TLD: Beta, Gamma, X-ray & Neutron

2. Center for Waste Management.Serpong Facility, BATAN

None Film: Gamma, X-ray

3. MOH: BPFK Jakarta None Film: Gamma, X-ray4. MOH: BPFK Medan None Film: Gamma, X-ray5. MOH: BPFK Surabaya None Film: Gamma, X-ray6. MOH: BPFK Makassar None Film: Gamma, X-ray

Institution no 2, 3, 4, 5, and 6 (BPFK is part Ministry of Health) are in preparation to obtain an accreditation from National Accreditation Institution.

3.2. Calibration of Monitoring Equipment for External Radiation

The SSDL is in BATAN and is also called as SSDL-Jakarta. The facility is available for the purpose of calibrating 100 kV X-ray to gamma ray (Co-60) used in radiotherapy. The standard used is traceable to BIPM-France. For calibration of 4 kV X-ray to gamma ray (Co-60) used in radiation protection, the standard is traceable to PTB-Germany. Furthermore, for neutron (Am-Be) calibration used in radiation protection, the standard is traceable to ETL-Japan. The quality management system of SSDL BATEN is in the process of national accreditation on SNI 19-17027 (ISO 17025).

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3.3. Individual monitoring for and of an assessment of intakes radionuclides

Dosimetry services are available for direct monitoring of intakes radionuclides, while for indirect measurement is also available by bioassay method using Low Background Counter Instrument. The management system uses GLP (Good laboratory Practice) and in the preparation toward national accreditation system.

3.4. Workplace monitoring

Workplace monitoring has to be conducted by every nuclear installation and radiation facility as it is stated by Article No. 14 of GR No 63 Year 2000. The licensee of those installations has to provide radiation protection equipments, individual dose monitoring, workplace monitoring and also environmental monitoring system (Article No. 18 of GR No 63 Year 2000). Regulatory inspection performed by BAPETEN also verify if licensee carry out workplace monitoring regularly

3.5. Assessment of exposure of sources natural radiation

Within the last three Years, BAPETEN conducted assessment of NORM and TENORM in some potential places such as tin mining. This assessment is a pilot project to develop a guideline of format and content of safety report, which has to be submitted by Mine Company that potentially resulting radioactive waste. This requirement is stated in Article 32 of GR No. 27 Year 2002.

3.6. Central dose record keeping for external and internal exposure

All dosimetry services send their evaluation result of film or TLD badge to BAPETEN. Since the last three Years, Central dose record keeping for external and internal exposure has been carried out by BAPETEN.

IV. CONTROL OF MEDICAL EXPOSURES

There are some basic regulations for authorization and safety requirements for utilization of radiation source and radioactive materials for medical purposes, i.e.:

GR No. 63 Year 2000 on Safety and Health against Ionizing Radiation; GR No. 64 Year 2000 on Licensing of Nuclear Energy Utilization; GR No. 26 Year 2002 on Safe Transport of Radioactive Material; and GR No. 27 Year 2002 on Radioactive Waste Management.

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4.1 Patient protection in diagnostic (and interventional) radiology

Currently, BAPETEN is in the process of establishing Chairman Decree on “Safety Provision in Diagnostic Radiology.” It will amend the Chairman Decree No. 01P/Ka-BAPETEN/I-03 on Guidance Level for Radiodiagnostic Patient” (established in January 2003.) The final draft of Chairman Decree was presented to the users in the end of May 2004 for the purpose of public hearing. This document governs both diagnostic and interventional radiology, and is mainly refers to BSS-115 and IAEA Safety Guide No. RS-G-1.5 (2002). Internally, this draft refers to Chairman Decree No. 01/Ka-BAPETEN/V-99 on Occupational Radiation Safety (This Decree is also in the process of amendment based on BSS-115). Other international standards are also used in the draft particularly in the chapter of quality assurance in diagnostic radiology.

The draft of Chairman Decree on “Safety Provision in Diagnostic Radiology” is comprised of:

1. Safety principles: justification, optimization (including guidance levels) and limitation;

2. Administrative principles:a. Organization: Requirement for radiologist, medical physicist, medical

radiographer, radiography operator, radiation safety officer and nurses, andb. Quality assurance, including quality control by means of compliance test

protocol and mechanism;3. Technical requirements: Design considerations, radiation source device requirements,

operational considerations, facility requirements, installment, radiation protection equipment; and

4. Investigation on medical exposure accident.

4.2 Patient protection in interventional radiology

(See 4.1 above)

4.3 Patient protection in Nuclear Medicine

A specific regulation governing patient protection in nuclear medicine is under an assessment by BAPETEN. The requirements will refer to the IAEA Safety Guide No. RS-G-1.5 (2002) on “Radiological Protection for Medical Exposure to Ionizing Radiation and the Appendix II of BSS-115.

4.4 Patient protection in Radiotherapy

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In the end of 2002, BAPETEN established Chairman Decree No. 21/Ka-BAPETEN/ XII-02 on “Quality Assurance Program for Radiotherapy Installation” based fully on the IAEA-TECDOC-1040 (1998) on “Design and implementation of a radiotherapy programme: Clinical, medical physics, radiation protection and safety aspect.” In September 2003, BAPETEN in coordination with Ministry of Health and Indonesian Radiation Oncologist Society (PORI) organize a national seminar on this chairman decree. Professors of universities; radiation oncologist, medical physicist and hospital director (as licensee and or employer) of all 19 hospitals with therapy facility came to the seminar. Recommendation was made to improve the facility equipment, personnel training and quality management system. Starting in this Year, BAPETEN perform quality audits in radiotherapy installations as a pilot project. BAPETEN planned to do this quality audits annually.

Currently, BAPETEN is carrying out a draft making of Chairman Decree on Safety Provision on Radiotherapy. It would be expected that the final draft would be finished by the end of this Year, prior to public hearing and the stipulation.

BAPETEN sent some medical physicists to some RTCs organized by the IAEA/RCA. A national training course for medical physicist and radiographers will help improve quality and safety of radiotherapy installation.

4.5 Type approval of radiation sources for medical use

All utilization of radiation sources and radioactive materials for medical purposes are subject to licensing under GR No. 64 Year 2000 on Licensing of Nuclear Energy Utilization. Expected amendment of this GR and GR No 63 Year 2000 will classify levels or types of authorization based on the IAEA-TECDOC-1067. This amendment is expected to be accomplished in 2005.

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V. CONTROL OF PUBLIC EXPOSURES

5.1. Control of Radioactive Discharges

In a facility utilize unsealed sources; radioactive wastes can be in the form of liquid, gaseous, or a solid waste. Short lived solid and liquid wastes should be managed by the user itself. There are two principles applied here. Firstly, the radioactive wastes should be collected and stored for a sufficient time under controlled conditions until they decay to below a clearance limit. Secondly, radioactive waste can be discharge to the environment after the user obtains an authorization from BAPETEN cq. Directorate for Licensing of Radioactive Material and Radiation Source.

For clearance level, BAPETEN adopts the IAEA-TECDOC-1000 on “clearance of materials resulting from the use of radio nuclides in medicine, industry and research”.

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According to GR No. 63 Year 2000 on The Safety and Health of Ionizing Radiation Utilization, the user shall to monitor the radioactivity level in the environment routinely, periodically, and/or incidentally and the record of the document must to be sent to BAPETEN periodically.

BAPETEN’s Inspector shall perform inspection to installations to verify the compliance with regulations and or license requirements.

5.2. Environmental and Food Monitoring

The current requirement related to Environmental and Food Monitoring in Indonesia is a performance-based requirement. Environmental and Food Monitoring are required to be secured from unauthorized removal. Since Nuclear Power Plant until now are not yet establish, therefore there are no risk to environmental and food Monitoring. Indonesia have clear procedure to Environmental Monitoring. Minister Decree for Environmental number 86 Year 2002 were made a Guidance for Environmental Management and Monitoring.

5.3. Control of exposure to Radon

Research on Radon in mine activities and a building have been done by National Nuclear Energy Agency (BATAN). The result of the research concluded that concentration activity of Radon in dwelling, building are not significant yet to control by regulation.

5.4. National waste management strategy

Legally, waste management is one of the most important field in nuclear safety in Indonesia. It is regulated in the highest legislation system, Nuclear Energy Act number 10, 1997. According to the Act, National Nuclear Energy Agency (BATAN) has their responsibility to conduct the waste management technology, and provides final repository for high level radioactive waste. BATAN may manage radioactive wastes as long as they fill all technical and regulatory requirements for it and has a valid licence from Regulatory Body/ BAPETEN. Furthermore, BATAN has a unique responsibilities to provide technical guidance to all radioactive waste management facilities in Indonesia. According GR (GR) number 27 Year 2002 on Radioactive Waste Management stated:

(1) Any nature or legal person deems to undertake utilization of nuclear energy shall declare to BAPETEN whether their existing and anticipated radioactive waste will be returned to the original country or removed and submitted to BATAN.

(2) The return of radioactive waste as referred to in paragraph (1) shall obtain approval from BAPETEN.

(3) In the case of BATAN shall manage the radioactive waste as referred to in paragraph (1), BAPETEN shall notify such manner to BATAN.

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5.5. General Safety Provisions For radioactive Waste

Radioactive waste shall be managed within an appropriate legal framework of radioactive waste management. It has been established through act, regulations, guides etc.

1. Nuclear Energy Act,Chapter VI of the Nuclear Energy Act No.10, 1997 entitled “ Radioactive Waste

Management” consists of six Articles, in the basis of radioactive waste management regulation in Indonesia.

2. GR In the case of radioactive waste management, the implementation of Nuclear Energy Act No.10, 1997 is regulated by GR (GR). GR No. 27 Year 2002 on Radioactive Waste Management is adapted from the IAEA Safety Series No.111-F; No.111-S-5, and No.111-G-1.

3. Decrees of Chairman of BAPETENThe GR are further implemented in the forms of Decrees of Chairman (DC) of

BAPETEN. DC No. 03, 1999 on “The Safety Provisions on Radioactive Waste Management” was established 1999 adapted from Safety Series No.12, 1965 and DC No. 11,1986 on “The Technical Guidance for the Radioactive Waste Management by the User” based Safety Series No.12, 1965.

5.6. Treatment of Radioactive Waste

A short lived solid and liquid wastes should be managed by the user itself. Radioactive wastes shall collect, classify or conduct treatment, and store the radioactive waste in interim storage facilities prior to removal and submission to BATAN or radioactive wastes should be directly released to the environment within the limit of clearance level;

Radioactive waste with long half-live or one that mixed with toxic matter, such as from therapy application, have to be treated specially before disposal. Beside a chemical treatment, the incinerator or compactor is used to reduce the volume of the waste. Then, may send the waste to BATAN waste facility for final storage;

Long lived sealed sources should returned to the manufactures/ supplier in its original country or sent to BATAN.

5.7. Control of Discharge from the Management of Radioactive Waste

In Indonesia, Control of Discharge from the Management of Radioactive Waste are issued authorizations that require renewal pending to the evaluation from the inspection. Licensees usually overlook to renew their license. GR No. 63 Year 2000 on “The Safety and Health of Ionising Radiation Utilization stated , the releases of radioactive material into the environment from all facilities shall not surpass the dose limit for the members of public, and “The user shall keep all documents containing the workplace monitoring results, radioactivity environmental monitoring results. BAPETEN has adopted IAEA –TECDOC-1000 on Clearance of materials resulting from the use of radio nuclides in medicine, industry and research.

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BAPETEN shall perform inspection to installations to verify the compliance with regulations and or license requirements or conditions. Inspection shall be executed by Nuclear Safety Inspectors assigned and laid off by Regulatory Authority.

5.8. Clearance Region for Radioactive Waste

The same as 5.1.5.9. Storage of Radioactive Waste

The user’s storage facility of radioactive waste shall satisfy the minimum requirements, which are to:

a. avoid flood and erosion;

b. earthquake reliance and considering characteristics of earth material and water chemistry;

c. be equipped with radiation monitoring system and environmental radioactivity;

d. be equipped with coolant system;

e. be equipped with shielding system (defense in depth);

f. be equipped with physical protection system;

g. consider population distribution and region order in the vicinity of storage location; and

h. to assess external radiation exposure rate .

The radioactive wastes could be stored under a controlled conditions and need a license from BAPETEN. The maximum time in a user’s storage is 5 Years, then, they must sent to BATAN or returned to supplier.

5.10. Disposal of Radioactive Waste

GR of the Republic of Indonesia number 27 Year 2002 on Radioactive Waste Management stated, “Interim storage for low level, intermediate level, and high level waste shall fulfill the minimum requirements below:

a. flood-free location;

b. earthquake reliance;

c. design of building suited to the radioactive waste quantity and characteristics, and pollution surveillance measures;

d. equipped with radiation protection devices; and

e. periodical environmental monitoring”.

5.11. Decommissioning of Waste Management Facilities and Radioactive Waste from the Decommissioning of Nuclear and Other Facilities

GR No. 27 Year 2002 on “Radioactive Waste Management” stated,

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Prior to undertaking decommissioning of radioactive waste treatment installation, any of waste treatment facilities shall submit documents of decommissioning program to BAPETEN.

Chairman Decree No. 07-P/Ka-BAPETEN/I-02 has given guidance on Decommissioning of Medical, Industrial and Research Facilities and Non Reactor Nuclear Installations.

Regulatory Body shall to assess the decommissioning program.

Radioactive waste generating from decommissioning shall be removed and submitted to BATAN.

5.12. Rehabilitation

After successful completion of the decommissioning, BAPETEN has to declare that facility and the site can be released from regulatory control. BAPETEN has an authority over rehabilitation within the Country, BAPETEN Chairman Decree number 07-P/Ka-BAPETEN/I-02 have given a Guidance on Decommissioning of Medical, Industrial and Research Facilities and Non Reactor Nuclear Installations.

VI. TRANSPORT SAFETY

6.1. National Competent Authority for the Safe Transport of Radioactive Material.

Based on Act No. 10 Year 1997 on Nuclear Energy, Indonesia established an regulatory body called Nuclear Energy Regulatory Agency (BAPETEN). BAPETEN is the only competent authority which has responsibility to control any uses of nuclear energy including during transportation of radioactive material. To carry out this responsibility BAPETEN formulate regulations, issue licenses, and inspect activities any uses of nuclear energy. Article 17 Act No.10 Year 1997 states that any person shall have license before they start to use nuclear energy including transportation of radioactive material.

National legislation relating to the transportation of radioactive material has been established are:

a. Act No. 10 Year 1997 on Nuclear Energy.b. GR No. 64 Year 2000 on Licensing of Nuclear Energy Utilization.c. GR No. 26 Year 2002 on Safe Transport of Radioactive Material.d. Chairman Decree of BAPETEN No. 04/Ka-BAPETEN/V-99 on Regulation of the Safe

Transport of Radioactive Material.e. Chairman Decree of BAPETEN No. 05-P/Ka-BAPETEN/V-99 on Guideline for Safety

Requirement of Transport of radioactive Material.

The act and GR contain general regulation to the licensee concerning what and how to fulfill all requirements. And for both above decrees of Chairman of BAPETEN in point c

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and d are reproduced based on from IAEA Safety Guide No. 6 Year 1985 contain more detail of technical aspects.

GR No. 26 Year 2002 regulates all aspect of safe transport of radioactive material which cover licensing, role and responsibility of shipper, receiver, and regulatory body, transfer cask, radiation protection program, quality assurance program, qualification of radioactive material, and emergency response.

The status of BAPETEN, the name and address has been officially communicated to

the Agency. Action plan implementation or effort will be done as follows:

a. To revise the Chairman decree No. 04.Ka-BAPETEN/V-99 which reproduced from IAEA Safety Guide No. 6 Year 1985 with new reference i.e. IAEA Safety Guide No. ST-1/2000 Rev 1.

b. To complete all procedures and/or guidelines which be ordered by some Article stated in the GR No.26 Year 2002.

c. To make closer cooperation and coordination among National departmental agencies.d. To send BAPETEN staffs in participating some training or workshops on Safe

Transport on Radioactive Material.e. To propose to invite the IAEA mission dealing with the Transport of Radioactive

Material.

6.2. Coordination and Cooperation at National and International Level.

As national competent authority, BAPATEN make close coordination and cooperation to other national relevant organization such as Department of Transportation, Custom body, State police department and others dealing with any transportation radioactive material. Even though there is no formal arrangement in term of memorandum of understanding (MOU) those relevant agencies have responsive close coordination to make appropriate team work together. Channel of communication to other relevant agency also be maintained by many different way such as managerial meeting, regular training course for radiation protection officer (RPO), and others. In some cases, BAPETEN staff optionally be invited as invited lecture by other department or institutions during their training course program dealing with radiation safety and or safe transport of radioactive material.

In Article 31 of the GR No. 26 Year 2002 states that ‘In case of accident during transportation, Shipper shall report to BAPETEN, to other relevant agencies and to receiver’. In order to propose a transport-permit as one of requirement, shipper shall submit a procedure to cope the most credible emergency or accident during their transportation. This emergency response procedure will be evaluated by BAPETEN before issuing a license of transportations.

In the international level BAPETEN have close cooperation with the Agency such as regularly report submission about import and export control of nuclear material. Indonesia also as a member of IAEA Illicit Trafficking Database programme. Indonesia has signed

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some international conventions which is in general or in part of their content have relation to safe transport of radioactive material, such as Nuclear safety convention, NPT, Physical Protection of Nuclear Material convention, Early notification of nuclear accident convention, Assistance in the case of Nuclear accident or radiological emergency convention, and SEANWFZ.

In regional level Indonesia is one member state to SEANWFZ (South East Asia Nuclear Weapon Free Zone) who participate to maintain safety and security in this region.

6.3. Compliance Assurance Program

BAPETEN perform main task to assure safety, security and safeguards during transportation of radioactive material, as stated in the GR No. 26 Year 2002. In this regulation cover all aspects to regulate the safe transport of radioactive material which cover licensing, role and responsibility shipper, receiver, and regulatory body, transfer cask, radiation protection program, quality assurance program, qualification of radioactive material, and emergency response.

BAPETEN perform its task by issuing rule and legislation, license and also doing inspection.

Licensing and inspection mechanism.

BAPETEN evaluates and reviews all transportation proposal before issuing any permit. Validation of any certificate is one of important step to assure the safe transport of radioactive material. All data submitted to BAPETEN shall be verified by inspection in appropriate way in order to conform completeness and correctness. For international transfer of radioactive material via any border of neighboring country, the specified custom body in the border will take offer this task to verify all transport document validation including license to transport of radioactive material issued by BAPETEN. In order to combat of illicit trafficking entering to and exit from this country still has to be improved because Indonesia is the bigger country with more than 60% water and very long cost over the country. Present condition of lacking equipments and instruments to detect any illicit transfer in the legal border become the most priority consideration and it should be taken in the first steps near future.

VII. PLANNING FOR AND RESPONSE TO RADIATION EMERGENCIES

7.1. National level arrangements for emergency preparedness and response

In 2002 BAPETEN (National Energy Regulatory Agency) proposed a preliminary draft on the establishment of national nuclear emergency center. In the following Year, all organization involved in the management of a nuclear emergency were identified and initial

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coordination with those organization, such as the National Coordinating Agency Emergency Management (BAKORNAS PBP), the National Nuclear Energy Agency (BATAN) and the Department of Health was started. BAKORNAS PBP is the national coordinating agency for emergency management that deals with natural and man-made disaster and is directly responsible to president and is managed by the office of the vice president.

Currently, BAPETEN is in the process of proposing a draft, which will be issued by the BAKORNAS PBP, that will appoint BAPETEN as the coordinator in case of nuclear or radiation emergencies. BAPETEN is also in the process of improving the coordination and revising the draft on the establishment of a national nuclear emergency center and it is hopes that by the Year 2006 BAPETEN will have a memorandum understanding is in place, BAPETEN will formally begin to establish a national radiation emergency plan and to test it.

Internally, however, BAPETEN is currently in the process of establishing its own procedures in dealing with radiological emergencies and it is planned that by the end of 2005 the procedures and the relevant work instructions will be in place.

7.2. Emergency preparedness and response for licensed facilities and practices

The Government of the Republic Indonesia has issued GR No 63 Year 2000 on the safety and health of ionizing radiation utilization, in which chapter VI of the regulation deals specifically with radiation emergency response, as shown in Apendix 1. Furthermore, BAPETEN has issued decree of Chairman of BAPETEN No. 05-P/I-2003 decree is still in Indonesian and no English translation is available at the moment. The decree itself is now being revised to include the categorization of installation with medium to high potential radiological impact.

So far, the only installation that regularly has emergency response drills is the national nuclear energy agency (BATAN). We suspect that other installation’s failure to regularly have emergency response drills is duo to installation’s unfamiliarity with the decree of Chairman of BAPETEN No. 05-P/I-2003. In order to remedy this situation, BAPETEN has programmes to familiarize the installation with the decree.

Currently, BAPETEN is in the final process of drafting a decree of chairman of BAPETEN on incident reporting system for research reactor as a preparation to join IAEA’s IRSRR. It is planned that in 2006, the decree will be isuued and Indonesia will aplly dor a membership in IAEA’s IRSRR

7.3. Medical preparedness for emergencies

All hospital that have radiotherapy and nuclear medicine installation, including BATAN’s clinc in its 3 search are capable to give first aid and mange the treatment of radiation injured injuries in case of nuclear and radiation emergencies, although they do not necessarily have separate rooms to decontaminate persons

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In 2002 BAPETEN proposed a preliminary draft on establishment of several referral centers/hospitals in the case of nuclear or radiation emergencies. Since then, coordination with several major hospitals and the department of health has been underway to establish such center/hospitals. The main problem in the establishment of such center/hospitals is lack of human sources, equipment and special rooms to manage the treatment of radiation injures injuries in case of nuclear and radiation emergencies.

This Year, a final draft on the establishment of several center/ hospital in the case of nuclear or radiation emergencies is expected and it is hoped that in 2005, a memorandum of understanding between BAPETEN, the hospital and the department of health will be reached. Once the memorandum of understanding is in place, a pilot project on the referral hospital will be started.

APPENDIX I

CHAPTER VIRADIATION EMERGENCY RESPONSE

Article 32

The operator shall implement the radiation emergency response

Article 33(1). In the case of radiation accident, the operator shall carry out the emergency preparedness;

(2). For the purpose of radiation emergency preparedness mentioned in Clause (1), the human safety shall be the first priority;

(3). In the case of a radiation accident, the operator shall immediately report the process of accident and its emergency response to the Regulatory Body and other related competent authority.

Article 34

(1). The operator of the high potential radiological installation shall has the emergency response plan to prevent potential hazards from the anticipated radiation accident during installation operations.

(2). The emergency response plan mentioned in clause (1) shall be provided by the operator, and at least shall include:a. The type/classification of accidents that may happen in the installation;b. Emergency response for each type/classification of accidents;c. Emergency response organizations;

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d. Emergency response procedure;e. Available emergency response equipment;f. Emergency response personnelg. Emergency response training;h. Communication system with other competent authorities concerned with the emergency

response.

Article 35

The provisions mentioned in Article 33 and Article 34 will be further regulated by the decree of chairman of the regulatory body.

VIII. EDUCATION AND TRAINING BAPETEN

8.1. Overview of Training Infrastructure in BAPETEN

Since the institution of BAPETEN in 1998, education and training has been one of its main duties. Growing number of practices using nuclear technology has not attained by adequate resources in maintaining safe use of radiation sources. Thus BAPETEN has the obligation to achieve sufficient level of capabilities and competencies among the users of radiation sources for the sake of public safety and welfare. To further enhance effectiveness and performance, BAPETEN ought to develop its human resources through suitable education and training, thus achieving appropriate knowledge and expertise in carrying out their duties. Consequently, training infrastructures have been established to cater the need of radiation protection personnel in various nuclear related practices. The major training infrastructure in Indonesia are as follows:

a. Education institutes

In the past few Years, there has been a decline in public interest in the study of nuclear technology, fewer students enrolled in nuclear science subject, resulting in closure and amalgamation of nuclear science department in universities. Yet the demand for the professionals in nuclear technology is increasing, especially in medical practices. To anticipate changes in public interest, BAPETEN has been assisting universities in providing nuclear related post graduate degree, especially in the field of medical physic and nuclear medicine. In addition, BAPETEN also collaborates with UGM in providing the degree in Industrial Safety, with carries out substantial study on radiation protection.

b. College for Nuclear Technology (STIN) in Yogyakarta

The establishment of College for Nuclear Technology is needed to supply professionals in nuclear technology as well as to response lower participation of public education on the subject. The college, which is under the auspices of BATAN, is the only institution that

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provides bachelor degree in nuclear science and technology, hence matching the demand of young nuclear engineer in Indonesia. Until now, STTN has produced 300 high quality graduates who finally dedicate their knowledge in various nuclear-related practice in Indonesia. BAPETEN maintain close ties with STTN, especially in promoting the role BAPETEN in regulating the use of radiation sources, BAPETEN regularly conducts seminar, training, and short courses in STTN to enhance safe practice in their future workplace.

c. Overseas and domestic planning

In order to the basic knowledge in radiation protection maintained by tertiary education system, advance training courses are established in Indonesia. Most of these training course require skill and experts such that collaboration with domestic and international partners is necessary. BAPETEN, works together with department of health to perform radiation safety training course for medical practitioners. International and bilateral cooperation is particularly helpful in providing technical know-how and skills and therefore achieving higher capabilities and competencies in safe use of radiation sources. As to match the growing needs training, BAPETEN itself undertakes 10 to 20 training courses with qualified instructor from BATAN and BAPETEN. Currently, BATAN and BAPETEN are the only national training institutes that cater for radiation protection training courses.

8.2. Education and training for radiation protection officers and experts.

Any national training institutions could organize radiation protection training courses after obtaining accreditation from BAPETEN. Accredited institution are given the opportunity to conduct their basic training course for radiation protection officers (RPO) provided that they have met teaching requirements established by BAPETEN. The basic requirements for RPO course would range from standard curriculum, suitable qualification of teaching personnel to adequate teaching facilities. Here BAPETEN has the duty to oversee, evaluate and maintain standards of the training courses, hence sufficient competencies and capabilities of RPO are established. At the present, only Education Training Center (ETC) of BATAN has been fully accredited and recommended by BAPETEN. ETC of BATAN carries out seven-in house RPO training course annually. In addition, they conduct training courses in other places if requested, especially when large number of participant in the corresponding area of requesting parties involved. There is no provision for on the job training in RPO training course. Having completed the RPO training course, the RPO will receive license from BAEPETEN after passing basic RPO examination satisfactorily. As to maintain adequate level of knowledge, BAPETEN conducts requalification training course for RPO. The officers are required to undertake requalification training course minimum twice within five-Years license period.

It is important to note the level of radiation protection in Indonesia is far from

adequate in medical practices. With the establishment of standard radiation protection program through out the country, there has been a sudden shortage of radiation protection officers in medical practices. Hence, starting the Year 2000 BAPETEN has developed a crash training program with the objective to accelerate the capability and improve radiation

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protection program in medical practices. It is expected that within 5 Years, 1500 radiation protection officers will be available to serve in medical practices.

In order to improve the quality of trainees, BAPETEN works together with competent institutions to conduct Training for Trainers (TOT). Additionally, fellowship are available for qualified personnel to pursue higher degree in local and overseas universities, such that expertise on the subject could be achieved.

8.2. Education and training for manager and workers

BAPETEN has close cooperation with ETC of BATAN and department of health to develop the curricula of basic radiation protection training course for radiation workers. Most of the training program are self sustaining and therefore reduce the workload of BAPETEN.

There has been discussion to prepare practice-specific curricula of the radiation protection training course for nuclear facilities, therapeutics, diagnostic, industrial, and academic practices. These are important recommendation for BAPETEN in promoting safe use of radiation sources.

8.3. Education and training for medical and paramedics professionals

In order to maintain adequate level of radiation protection in medical practices, BAPETEN maintains close cooperation with medical association (such as Physician Association of Indonesia-IDI) to carry out basic radiation protection training courses for medical personnel. It is expected that training courses could fulfill the shortage of knowledge in medical practices, especially among physicist and nurses. BAPETEN also works with relevant medical association to organize seminars promoting safety of medical professionals and the benefits of patients. In addition, BAPETEN initiated visits to hospitals and medical institutions to provide guidance on the safe use of radiation sources.

Currently, very few universities in Indonesia specialize in nuclear technology. Some universities offer education in nuclear physics as post graduate programs in faculty of medicine. The universities that provides these program s are University of Indonesia with master degree in Medical Physics, and Diponegoro University and Padjajaran University with Master degree in Nuclear Medicine.

8.4. Education and training peripheral personnel

Throughout the country, there are more than 2000 license holders in medical practices and 600 license holders in industrial. In order to ensure safe use of radiation sources, the users hold close collaboration with BAPETEN and BATAN in improving their human resources. As mentioned earlier, BAPETEN along with BATAN train their respective RPO and provide technical assistances in maintaining high safety standards in their domains. BAPETEN in cooperation with ETC of BATAN conducts training courses for peripheral

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personnel upon request, specially providing them basic knowledge in radiation safety. The training program could be conducted in ETC facilities or in their corresponding area (in house training). These training program becomes necessary when new procedures have been established or new equipment have been introduced. BAPETEN also conducts trainings for peripherals staff of licensee holding institutions, especially in disseminating new regulation or recommendations from BAPETEN.

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