Last update : June 24, 2015 National competent authoritiesNational competent authorities: Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety (BMUB) – responsible for the implementation of the Atomic Energy Act and the Radiation Protection Ordinance Federal Ministry for Labour and Social Affairs (BMA) - responsible for the implementation of the X-Ray Ordinance. Federal Office for Radiation Protection (BfS) - subordinated to the BMUB BfS hosts the Occupational Radiation Protection and Radiation Protection Register, i.e. the central dose register for individual surveillance of radiation workers (situated in Munich), BfS Coordinating Office on Incorporation Monitoring in Germany (In vivo: two wholebodycounter and partial counter, in vitro: radiochemical laboratories for excretion analysis, situated in Berlin and Munich). Regulatory authorities The direct competencies and responsibilities in relation to the monitoring of occupationally exposed workers and the compliance of their doses with the dose limits are in the hands of some 120 local regulatory authorities in the sixteen Federal States in Germany. These regulatory authorities (“Gewerbeaufsichtsämter”) are responsible for the safety of work and technical installations. Where occupational exposure to ionising radiation is possible these regulatory authorities act as regulators who licence companies and control their radiation protection. Due to the federal system, the de-centralised structure of the state governments with different responsibilities and resources between the ministries, it is not possible to assign the competencies to only one ministry or central authority. National legislative frameworkMain texts of the national regulation: National legislative framework Fundament is the Atomic Energy Act (Act on the Peaceful Utilisation of Atomic Energy and the Protection against its Hazards) (“Atomgesetz”) [[1]]. The Atomic Energy Act contains general regulations concerning the production of nuclear energy and protection against its hazards. It states the general provisions for the safety of nuclear installations. The Atomic Energy Act sets requirements for the employment of persons in places with potential exposure to ionising radiation. Work should be allowed only after appropriate medical examinations were executed by an specially authorised physician (§12.3). The monitoring and recording of occupational exposure should be regulated in the appropriate legal ordinance (§12.4). §12c establishes the Radiation Protection Register. It regulates generally the tasks of this central dose register, the recording and the access to the dose data. Subordinate to the Atomic Act are two Ordinances which transpose the Guideline 96/29 EURATOM and in which the provisions for the protection of occupationally exposed workers are laid down: Ordinance on the Protection Against Damages Through Ionising Radiation (Radiation Protection Ordinance, "Strahlenschutzverordnung"), [[2]] Ordinance on the Protection Against Damages Through X-Ray Radiation (X-Ray Ordinance, "Röntgenverordnung") [[3]] The main difference between the two ordinances lies in their area of application and in the responsibility for their implementation. The X-Ray Ordinance has to be applied in facilities with X-ray installations or other electric sources of ionising radiation where the energy of produced X-rays is ³ 5 keV and where the energy of accelerated electrons is £ 3 MeV. Responsible for implementation of the X-Ray Ordinance is the Federal Ministry of Employment and Social Affairs (BMA) and its corresponding state ministries. The radiation protection in all other facilities where exposure to ionising radiation is possible is regulated by the Radiation Protection Ordinance. The responsibility for their implementation is vested to the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety (BMUB) and its corresponding State Ministries. The General Administrative Directive for Radiation Passes [[4]] contains the content of the radiation passbook for outside workers and the administrative procedures for the passbook issuing and registration. Radiation passbooks are also issued, to labour-forces who execute activities with enhanced exposure to natural sources. The Ordinance on the Establishment of a Radiation Protection Register is identical with §112 StrlSchV and §35a RöV) [[5]]. It regulates the data transfer from dosimetric services to the radiation protection register, the dose and the personal data that should be transferred and the time limits for the transfer, the requirements to the registration authorities for the transfer of information about issued radiation passes to the Register, the access to the individual dose data in the Radiation Protection Register and the utilisation of dose data for scientific research, that the X-Ray Ordinance complies with Art. 12c of the Atomic Energy Act and sets the same requirements for the transfer of dose and personal data to the radiation protection register as in the area of he application of the Radiation Protection Ordinance. Subordinated to the Radiation Protection Ordinance and X-Ray-Ordinance are several guidelines and recommendations. They contain requirements for the technical equipment, quality assurance, procedures for dose determination, assessment, documentation and information flows, calculation tables etc.. They are addressed primarily to regulatory bodies and dosimetry services. For dose monitoring from external exposure: Guideline Requirements for Dosimetry Services for Person Doses [[6]] Requirements for Personal Dosemeters (Recommendations of the Radiation Protection Board) [[7]] Guideline for Physical Radiation Protection Control for the Determination of Body Doses Part I: Determination of the body dose from external exposure [[8]] Determination of radiation exposure from cosmic exposure of air crews (Recommendation of the Radiation Protection Board) [[9]] For dose monitoring from internal exposure: Guideline for Physical Radiation Protection Control for the Determination of Body Doses Part II: Determination of Doses from Internal Exposure [[10]] including Requirements for Laboratories for Incorporation Measurements Guideline for Assessment of Exposures by Incorporated Radiation Emitters Guideline for the monitoring of radiation exposure from activities (i.e. exposure from natural sources) [[11]]. The procedure to implement an act, ordinance or guideline for radiation protection on a federal level is quite long. The proposals have to be discussed and approved by the concerned federal ministries and the respective federal authorities. To accelerate the agreement, two committees with representatives of all states discuss new proposals: State Committee for Atomic Energy ("Länderausschuss für Atomenergie") State Committee X-Ray Ordinance ("Länderausschuss Röngenverordnung") Both committees have sub-committees which meet regularly and discuss actual matters in order to reach a harmonised transposure of radiation protection between the different Federal States. References [1] Gesetz über die friedliche Verwendung der Kernenergie und den Schutz gegen ihre Gefahren (Atomgesetz), issued 15.07.1985, (BGBl I S.1565) last version from 12.08.2005 (BGBl, I S. 2365) [2] Verordnung über die Umsetzung von EURATOM-Richtlinien zum Strahlenschutz, Art. 1, Verordnung über den Schutz von Schäden durch ionisierende Strahlen (Strahlenschutzverordnung - StrlSchV) from 20.07.2001, BGBl I S. 1714 ber. I 2002 S. 1459). [3] Verordnung über den Schutz von Schäden durch Röntgenstrahlen (Röntgenverordnung - RöV) from 30.04.2003, BGBl. I S. 604, BGBl. III 751-13). [4] Allgemeine Verwaltungsvorschrift zu § 62 Abs.2 Strahlenschutzverordnung ("AVV Strahlenpass") vom 20.07.2004 (BAnz. Nr. 142a vom 21.07.2004 S. 1) [5] Strahlenschutzregisterverordnung from 3. April 1990 (BGBl. I/90, S. 607) [6] Richtlinie über Anforderungen an Personendosismessstellen nach Strahlenschutzverordnung und Röntgenverordnung vom 10.12. 2001, (GMBl. 2002 S. 136). [7] SSK Empfehlung Anforderungen an Personendosimeter (BAnz. Nr. 112 vom 21.06.2003) [8] Richtlinie für die physikalische Strahlenschutzkontrolle zur Ermittlung der Körperdosen, Teil 1: "Ermittlung der Körperdosis bei äußerer Strahlenexposition (§§40,41,42 StrlSchV; §35 RöV) vom 08.12.2003, (GMBl. Nr. 22 vom 19.03.2004 S. 410) [9] Ermittlung der durch kosmische Strahlung verursachten Strahlenexposition des fliegenden Personals - Vorschlag zur Umsetzung des § 103 der Strahlenschutzverordnung – StrlSchV vom 19. Februar 2003, Empfehlung der Strahlenschutzkommission, (BAnz. Nr. 108a vom 13.06.2003 S. 1) [10] Richtlinie für die physikalische Strahlenschutzkontrolle zur Ermittlung der Körperdosis Teil 2: Ermittlung der Körperdosis bei innerer Strahlenexposition (Inkorporationsüberwachung) (§§ 40, 41 und 42 StrlSchV) (to be issued in 2006) [11] Richtlinie für die Überwachung der Strahlenexposition bei Arbeiten nach Teil 3 Kapitel 2 Strahlenschutzverordnung vom 15.12.2003, (GMBl. Nr. 22 vom 19.03.2004 S. 418) Provisions more stringent than the Directive EURATOM: YesOccupational lifetime dose limit: 400 mSv. Organdose limits: 20 mSv/Year: eye lens (in future, persently 150 mSv/year), 50 mSv/year: gonades, ovaries, red bone marrow, uterus, 150 mSv/year: bladder, brain, breast, upper and lower colon, small intestine, liver, lung, stomach, spleen, kidney, adrenal glands, pancreas, thymus, oesophagus, 300 mSv/year: bon surface, thyroid, 500 mSv/year: ancles, feet, forearms, hands, skin. National dose registerNational body responsible of national statistics: National dose register The German national dose register is called “Radiation Protection Register”. The basis for the establishment of Radiation Protection Register was set up in 1990 with the amendment of the Atomic Energy Act (§12 c) and the corresponding amendments of the Radiation Protection Ordinance and the X-Ray Ordinance. The main tasks of the Radiation protection Register, as stated in the Atomic Energy Act are: control of compliance with dose limits, regard for the principals of radiation protection. The Radiation Protection Register is operated at the Federal Office for Radiation Protection (BfS) and charged with the assembling of the individual dose data from the different dosimetrc services for external exposure and incorporation and with the control of dose limits. The SSR also provides annual reports for the federal authorities with exposure statistics and the results of the surveillance. Database content Personal information: Family name, surnames, former name, title, date of birth, place of birth1, sex, occupational category, employers category Employers information: name, address, employer's ID-number given by the dosimetry service, name, telephone, fax of radiation protection officer, name and address of regulatory authority, state, Monitoring information: begin and end of the monitoring intervals, monitoring reasons, Exposure conditions: type of exposure (external, internal whole body, partial body, type of radiation, particle energy, radionuclides, incorporation way) Dose assessment details: type, number of the used approved dosemeter, in the case of internal exposure - measurements method, activity, dose assessment procedure Dose information: personal whole body dose, partial doses, part of neutron dose, doses due to incorporation Classification of workers: In the context of the adoption of the new EU-BSS the present workers classification scheme will be updated in the next years, following the ESOREX Categories where appropriate. Two classifications are set in the register. One refers to employer categories, the other to the occupational categories of workers. The employer categories are divided into the two main sectors - medicine and industry - and subdivided in 15 sub-categories: Medicine: medical practice, hospital, clinic, sanatorium, dental practice, dental clinic, veterinary practice or clinic, spas, other medical offices. Industry, research and education: Fabrication, processing, services outside of the nuclear sector, research, development and education in natural science and technical fields, nuclear power plants, other nuclear facilities, transport, facilities for nuclear decommissioning, storage of radioactive materials, technical safety, regulatory authorities and qualified experts, facilities with exposure to natural radiation, other industrial facilities. The workers categories are classified in 5 main work sectors and 20 occupational categories: Medicine: X-ray diagnostics (only radiography), X-ray diagnostics (incl. radiography and fluoroscopy), nuclear medicine (only diagnostics), nuclear medicine (incl. therapy and diagnostics) with unsealed sources, radiation therapy, radiopharmacy, laboratory medicine, biochemistry, other medical practices Utilisation of radioactive materials, X-ray- and other electric sources of ionising radiation except nuclear facilities: handling sealed sources except production of radioisotopes and radiography, handling unsealed sources incl. production of radioisotopes, operation of X-ray tubes and other sources except radiography and non-destructive material testing, radiography with radioactive sources or X-ray tubes, operation of equipment for the X-ray fine structure analysis and fluorescence analysis, testing and servicing X-ray-tubes and other sources (accelerators) inc. its production. Nuclear facilities: Operation, monitoring inclusive radiation protection, technical service including radiography and maintenance, cleaning and decontamination, closing down nuclear facilities. Facilities for the production of ionising radiation: operation, production and maintenance of facilities for the production of ionising radiation and facilities for irradiation with radiation sources. Transport, conditioning and waste management of radioactive materials: transport, conditioning, decommissioning and storage. Other practices not to classify in the above criteria. Access to the data On request, information about individual registered data are available for competent regulatory bodies on request, the monitored worker on application, legal accident insurance organisations on application, employer's radiation protection officers on application, responsible medical practitioners on application. Utilisation for research projects The use of the data from Radiation Protection Register for research purposes has been foreseen with the establishment of the Register. In such cases the anonymity of the personal data must be guaranteed, the purpose of the study and the quantity of the needed information has to be carefully specified and the access to the data restricted only to the need of the study. Reports Periodically, the SSR produces an own annual report and annually dose distribution statistics on occupational exposure for the BMU and the German Parliament. These dose statistics are based on the individual dose recordings received from the dosimetry services. It is published in the annual reports of the BMU. Periodically, the BfS prepares also statistics on occupational exposure over longer time periods in order to follow the trends in the number of occupationally exposed workers, and in the collective and the average doses in main work sectors such as the nuclear industry or medicine. Emergence of the Radiation Protection Register Surveillance of radiation passbook registration: since 1995 Surveillance of personal dose measurements: since 1998 Surveillance of doses from incorporation: since 2002 Surveillance air craft crew exposure: since 2003 Surveillance doses from terrestrial natural sources: since 2003. Types of recorded data: Passive dosimetryInternal dosimetry: commited doses onlyMeasurements of internal exposure to radonAircrew external dosimetryNotional dosesData sender to the register: Only several dosimetry services (e.g. only officially approved dosimetry services)Other:Federal Office for Civil Aviation: calculated and accumulated monthly doses of Aircraft crews . About 70 registration offices for Radiation Passbooks send Information on the issuing or other administrative proceesesof of radiation passbooks. Doses received in another country: YesThere is no direct, electronic access to the data. On request, information about individual registered data are available for competent regulatory bodies on request, the monitored worker on application, legal accident insurance organisations on application, employer's radiation protection officers on application, responsible medical practitioners on application. Other access to the register data: WorkersAuthoritiesRPE/RPOOccupational doctorEmployerOther:legal accident insurance organisations on application,
