Guideline for the design approval procedure of packages for the transport of radioactive material, of special form radioactive material, low

Transcription

1 Guideline for the design approval procedure of packages for the transport of radioactive material, of special form radioactive material, low dispersible radioactive material and excepted fissile material R 003

2 Salzgitter, March 2017

3 Guideline for the design approval procedure of packages for the transport of radioactive material, of special form radioactive material, low dispersible radioactive material and excepted fissile material R 003 This publication contains the translation of Richtlinie für das Verfahren der Bauart-Zulassung von Versandstücken zur Beförderung radioaktiver Stoffe, von radioaktiven Stoffen in besonderer Form, von gering dispergierbaren radioaktiven Stoffen und von freigestellten spaltbaren Stoffen - R published in Verkehrsblatt, Amtsblatt des Bundesministeriums für Verkehr und digitale Infrastruktur (BMVI) of 9. Juni 2016 (VkBl. Heft 12, S. 430, 2016). The translation has been prepared by staff members of the Department GE 3 Behälterzulassungen, Transportgenehmigungen of the Federal Office for the Safety of Nuclear Waste Management (Bundesamt für kerntechnische Entsorgungssicherheit), Salzgitter, Germany. With the entry into force of the Act on the Organizational Restructuring in the Field of Nuclear Waste Management at the 30 July 2016, the corresponding specialised tasks of the Federal Office for Radiation Protection (Bundesamt für Strahlenschutz BfS) have been transferred to the Federal Office for the Safety of Nuclear Waste Management (Bundesamt für kerntechnische Entsorgungssicherheit BfE)

4 CONTENTS 1 SCOPE COMPETENT AUTHORITIES IN THE FEDERAL REPUBLIC OF GERMANY PACKAGE DESIGNS FOR THE TRANSPORT OF RADIOACTIVE MATERIAL DESIGNS FOR SPECIAL FORM RADIOACTIVE MATERIAL AND LOW DISPERSIBLE RADIOACTIVE MATERIAL DESIGNS FOR EXCEPTED FISSILE MATERIAL DESIGN APPROVAL PROCEDURES APPROVAL OF PACKAGE DESIGNS FOR THE TRANSPORT OF RADIOACTIVE MATERIAL APPLICATION APPLICATION DOCUMENTS DESIGN ASSESSMENT DESIGN APPROVAL VALIDATION OF FOREIGN PACKAGE DESIGN APPROVALS APPLICATION APPLICATION DOCUMENTS SAFETY ASSESSMENT VALIDATION APPROVAL OF DESIGN FOR SPECIAL FORM RADIOACTIVE MATERIAL AND LOW DISPERSIBLE RADIOACTIVE MATERIAL APPLICATION APPLICATION DOCUMENTS DESIGN ASSESSMENT DESIGN APPROVAL APPROVAL OF DESIGN FOR EXCEPTED FISSILE MATERIAL APPLICATION APPLICATION DOCUMENTS DESIGN ASSESSMENT DESIGN APPROVAL FEES

5 1 SCOPE This guideline explains the Ordinance on the Domestic and International Transport of Dangerous Goods by Road, Rail and Inland Waterways Verordnung über die innerstaatliche und grenzüberschreitende Beförderung gefährlicher Güter auf der Straße, mit Eisenbahnen und auf Binnengewässern (Gefahrgutverordnung Straße, Eisenbahn und Binnenschifffahrt GGVSEB); the Ordinance on the Transport of Dangerous Goods by Sea Verordnung über die Beförderung gefährlicher Güter mit Seeschiffen (Gefahrgutverordnung See GGVSee); and the Regulations on Certification and Licencing in Aviation LuftverkehrsZulassungsOrdnung (LuftVZO); if the design is subject to competent authority approval according to the above-mentioned rules and regulations for the transport of radioactive material as amended, which are based on the Regulations for the Safe Transport of Radioactive Material, 2012 Edition Specific Safety Requirements No. SSR-6 of the International Atomic Energy Agency (IAEA), for all designs for Type C, B(U), B(M) packages for radioactive material; packages for fissile material (CF, B(U)F, B(M)F, AF and IF); packages for non-fissile or fissile excepted uranium hexafluoride (Type H(U), H(M)); special form radioactive material; low dispersible radioactive material; and fissile material excepted under paragraph 417 (f) of the SSR-6 4. The design approval 1 is the precondition under public law for the manufacture and use of the designs mentioned above. The holder of the design approval is responsible for manufacturing a safe design and informing the user in an appropriate way of the intended use according to the design approval specifications (training, documentation for use and maintenance). The product liability of the holder of the design approval remains unaffected by the obligations under public law. 1 [comment on exact wording not applicable to English version] 5

6 2 COMPETENT AUTHORITIES IN THE FEDERAL REPUBLIC OF GERMANY 2.1 PACKAGE DESIGNS FOR THE TRANSPORT OF RADIOACTIVE MATERIAL The Federal Office for the Safety of Nuclear Waste Management (Bundesamt für kerntechnische Entsorgungssicherheit (BfE) 2 ) is responsible for the design approval of Type C, B(U) and B(M) packages and packages for fissile material (CF, B(U)F, B(M)F, AF and IF) The Federal Institute for Materials Research and Testing (Bundesanstalt für Materialforschung und -prüfung (BAM) 3 ) is responsible for the design approval of packages for non-fissile or fissile excepted uranium hexafluoride (Type H(U), H(M)) The BfE is responsible for the validation of foreign package design approvals. 2.2 DESIGNS FOR SPECIAL FORM RADIOACTIVE MATERIAL AND LOW DISPERSIBLE RADIOACTIVE MATERIAL The BAM is responsible for the design approval of special form radioactive material and low dispersible radioactive material. 2.3 DESIGNS FOR EXCEPTED FISSILE MATERIAL The BfE is responsible for the design approval of fissile material excepted under paragraph 417 (f) of the SSR DESIGN APPROVAL PROCEDURES 3.1 APPROVAL OF PACKAGE DESIGNS FOR THE TRANSPORT OF RADIOACTIVE MATERIAL APPLICATION The application for a package design approval according to section above should be sent to the BfE 5 in duplicate including all documents as required under section The BfE will send one copy to the BAM. The application for a package design approval according to section above should be sent to the BAM 5 in duplicate including all documents as required under section The BAM will send one copy to the BfE. The BfE and the BAM acknowledge receipt of the application. Applications will generally be processed in chronological order based on the date of receipt of the complete application documentation. 2 Bundesamt für kerntechnische Entsorgungssicherheit, Postfach , Salzgitter. 3 Bundesanstalt für Materialforschung und -prüfung (BAM), Berlin 4 For simplification, it is referred to IAEA regulation SSR-6 instead of referring to all regulations concerning the different modes of transport listed under section 1. 5 It is also allowed to send one copy of the application including the required documents to each of the institutions, i.e. BfE and BAM. This procedure must be indicated in the application. 6

7 3.1.2 APPLICATION DOCUMENTS The application documents must include at least the information required by the applicable paragraphs 6 of SSR-6 4. Compliance with all applicable requirements for the requested design approval shall be demonstrated by providing a Package Design Safety Report. The Technical Guide Package Design Safety Reports for the Transport of Radioactive Material 7, as amended, is to be taken as a basis for the preparation of the Package Design Safety Report. For an application for the design approval of Type B(M) packages and Type B(M) packages for fissile material (B(M)F) the following is to be added: a list of the requirements for Type B(U) or B(U)F package designs with which this package design does not conform; any proposed supplementary operational controls to be applied during transport which are necessary to ensure the safety of the package or to compensate for the deficiencies mentioned above; a statement relative to any restrictions on the mode of transport and to any special loading, carriage, unloading or handling procedures; and the range of ambient conditions (temperature, insolation) for which the package is designed. If computer codes are used for safety demonstration, it is up to the BfE and the BAM to require additional documents to show suitability and appropriate validation of these codes, such as: documents to show the extent and results of verification/validation of the code including the determination and justification of safety factors, if appropriate (conservatism); documents to show the verification of these codes on the basis of comparisons of calculations and other investigations (e.g. measurements); justification for the applicability of these codes including a statement of possible sources of errors, particularly for conditions for which sufficient verification has not yet been provided; assessment of the effects of modelling assumptions and simplifications as well as any other calculational parameter with influence on the calculated results, particularly on safety margins against the limits for safety related parameters; and justification of input parameters. Furthermore, the BfE and the BAM may require proofs of qualification for staff members performing the calculations DESIGN ASSESSMENT The BfE and the BAM carry out the comprehensive safety assessment of the design. They assess the Package Design Safety Report of a design with respect to compliance with the legal requirements. In detail, the BAM carries out the safety assessment with respect to the mechanical and thermal design, the release of radioactive material and the management system 8. Required tests with prototypes, models or single components are performed by the BAM. The BAM may accept tests conducted by other laboratories, provided that such laboratories can prove that they meet the requirements for appropriate testing equipment according to SSR-6 and SSG-26 9 and for testing 6 Paragraphs 807(c), 809, 812 and 815 in the 2012 Edition of SSR-6. 7 The Technical Guide Package Design Safety Reports for the Transport of Radioactive Material, as amended, is available on the BfE website. 8 BAM-GGR 011 Quality Assurance Measures of Packagings for Competent Authority Approved Package Designs for the Transport of Radioactive Material (This procedural rule as amended is available on the BAM website.) 9 Advisory Material for the IAEA Regulations for the Safe Transport of Radioactive Material (2012 Edition), Specific Safety Guide No. SSG-26 7

8 expertise under DIN EN ISO/IEC as amended. For designs according to section, above the BAM summarizes the results of the design assessment in an assessment report. The BfE carries out the safety assessment with respect to shielding, criticality safety, material assignment (LSA, SCO, LDM 11 ) and compliance with the activity limits concerning the radiological properties. For designs according to section above, the BfE summarizes the results of the design assessment with respect to shielding and material assignment in an assessment report. Additional conditions may result from the assessment report for the respective design approval. The competent authority for design approval as listed under section 2 above summarizes the results of the complete procedure DESIGN APPROVAL The competent authority according to section 2 grants the design approval, if the design assessment has been concluded with positive results. The approval certificate is generally issued for a validity period of three years. A deviation from this validity period may be requested by the applicant. This application needs to be substantiated. The validity period of the design approval will be extended upon application if the legal regulations have not changed substantially and safety related objections against an extension of the validity period are not raised, either. Such application shall include documents to show that all applicable requirements continue to be met. This includes, e.g., an assessment of the influence of advanced technical standards on the design as well as the practical experience feedback from using the design, particularly concerning the management system. A valid design approval certificate authorizes the manufacture of an unlimited number of packagings unless stated otherwise in the design approval certificate and subject to legal regulations (e.g. legal changes, transitional periods). Subject to other required approvals (e.g. shipment approval), any package may be transported if at the time of transport the following documents are available: a valid design approval certificate, a certificate of the inspections carried out before commencement of operation (certificate of acceptance) and the certificates of re-testing/re-inspection as required. Both, the BfE and the BAM maintain a register of the design approval certificates issued by them. The BfE and the BAM have the exclusive right to publish design approval certificates (including extracts of such certificates). 3.2 VALIDATION OF FOREIGN PACKAGE DESIGN APPROVALS APPLICATION The application for validation of a foreign package design approval should be sent to the BfE 5 in duplicate including all documents as required under section The BfE will send one copy to the BAM. The BfE and the BAM acknowledge receipt of the application. Applications will generally be processed in chronological order based on the date of receipt of the complete application documentation. 10 DIN EN ISO/IEC Allgemeine Anforderungen an die Kompetenz von Prüf- und Kalibrierlaboratorien General requirements on the competence of testing and calibration laboratories 11 LSA: low specific activity material SCO: surface contaminated object LDM: low dispersible radioactive material 8

9 3.2.2 APPLICATION DOCUMENTS The application must include at least the following documents: a) a copy of the foreign package design approval certificate; b) a German translation of this design approval certificate; c) if not included in the certificate, a reproducible illustration, not larger than 21 cm by 30 cm, showing the make-up of the package, including impact limiters, devices for thermal insulation and packaging inserts, if applicable; (The illustration shall indicate at least the overall outside dimensions, the masses of the main components of the packaging and the gross masses for empty and loaded condition.) d) a German translation of the complete Package Design Safety Report 12 ; e) a German translation 12 of the management system for use including all instructions necessary for use (including special stowage provisions or other instructions, e.g. for safe heat dissipation or for ensuring subcriticality), maintenance and re-testing/re-inspection as well as for operations during transport (including transfer between different modes of transport with the devices and conveyances applied) and in-transit storage; f) a German translation of the handling instructions; g) in the case of an application for validation of a design approval of Type B(M) packages and Type B(M) packages for fissile material B(M)F additionally: a list of the requirements for Type B(U) or Type B(U)F package designs with which this package design does not conform; any proposed supplementary operational controls to be applied during transport which are necessary to ensure the safety of the package or to compensate for the deficiencies mentioned above; a statement relative to any restrictions on the mode of transport and to any special loading, carriage, unloading or handling procedures; the range of ambient conditions (temperature, insolation) for which the package is designed; h) in the case of an application for a validation of a package design approval based on transitional arrangements, an additional statement indicating which of the requirements listed under section 1 above the package design does not meet and which are valid at the time of the application SAFETY ASSESSMENT The BfE and the BAM carry out the safety assessment. They assess the Package Design Safety Report of a design with respect to compliance with the legal requirements. Depending on the package design, the BfE determines the mode and extent of the assessment in consultation with the BAM. The BfE summarizes the results of the complete procedure VALIDATION The BfE grants the validation, if the safety assessment has been concluded with positive results. The validation certificate is issued for a validity period, which will not exceed the validity period specified in the original approval certificate. The BfE maintains a register of the validation certificates. The BfE has the exclusive right to publish validation certificates (including extracts of such certificates). 12 In consultation with BAM, BfE may agree to wholly or partially dispense with a translation. 9

10 3.3 APPROVAL OF DESIGN FOR SPECIAL FORM RADIOACTIVE MATERIAL AND LOW DISPERSIBLE RADIOACTIVE MATERIAL APPLICATION The application for a design approval of special form radioactive material should be submitted to the BAM including all documents as required under section in one copy. The application for a design approval of low dispersible radioactive material should be sent to the BAM 5 in duplicate including all documents as required under section The BAM will send one copy to the BfE. The BAM and, if involved, the BfE acknowledge receipt of the application. Applications will generally be processed in chronological order based on the date of receipt of the complete application documents APPLICATION DOCUMENTS The application documents must include at least the information required by the applicable paragraphs 13 of SSR-6 4. The BAM procedural rule BAM-GGR 017 Guideline for Testing and Approval of Special Form Radioactive Material 14, as amended, is to be taken as a basis for the preparation of the documents. These documents must include in particular: a) specification of manufacturer(s) of the design or design components; b) design identification; c) a detailed description of the radioactive material or, if a capsule, the contents, including the following information: nuclides/nuclide composition; activity and mass, if necessary; physical and chemical state; and nature of the radiation emitted including utilized radiation; d) a detailed description of the design, i.e. the complete drawings, material specifications and indication of markings; e) information on the proposed scope of application; f) documentation of performed tests 15 to show that the requirements are met; g) the management system for manufacturing and use for all manufacturers indicated as required under section a) above, including the specification of preparatory measures for transport DESIGN ASSESSMENT The BAM and, for low dispersible radioactive material, the BfE carry out the comprehensive safety assessment of the design (design assessment). They assess the Package Design Safety Report of a design with respect to compliance with the legal requirements. In detail, the BAM carries out the safety assessment with respect to the mechanical and thermal design, the release of radioactive material and the management system. For low dispersible radioactive material, the BfE carries out the safety assessment with respect to the radiation level and summarizes the results of the design assessment in an assessment report. Additional conditions may result from the assessment report for the respective design approval. 13 Paragraph 803 in the 2012 Edition of SSR The BAM procedural rule BAM-GGR 017 Guideline for Testing and Approval of Special Form Radioactive Material, as amended, is available on the BAM website. 15 In case of computer code application for safety demonstration the provisions set out in section apply accordingly. 10

11 The BAM summarizes the results of the complete procedure DESIGN APPROVAL The BAM grants the design approval, if the design assessment has been concluded with positive results. The approval certificate is generally issued for a validity period of five years. A deviation from this validity period may be requested by the applicant. This application needs to be substantiated. The validity period of the design approval will be extended upon application if the legal regulations have not changed substantially and safety related objections against an extension of the validity period are not raised, either. Except as required in the design approval certificate and subject to legal regulations (e.g., legal changes, transitional periods), a valid design approval certificate authorizes the manufacture of an unlimited number of special form radioactive material or low dispersible radioactive material. The BAM maintains a register of the design approval certificates. The BAM has the exclusive right to publish design approval certificates (including extracts of such certificates). 3.4 APPROVAL OF DESIGN FOR EXCEPTED FISSILE MATERIAL APPLICATION The application for a package design approval of fissile material excepted under paragraph 417 (f) of the SSR-6 4 should be sent to the BfE in duplicate including all documents as required under section The BfE will send one copy to the BAM. The BfE and the BAM acknowledge receipt of the application. Applications will generally be processed in chronological order based on the date of receipt of the complete application documentation APPLICATION DOCUMENTS The application documents must include at least the information required by the applicable paragraphs 16 of SSR-6 4. These documents must include in particular: a) a detailed description of the material; particular reference shall be made to both physical and chemical states; b) a statement of the tests that have been carried out and their results, or evidence based on calculative methods, to show that the material is capable of meeting the requirements to be excepted from classification as FISSILE ; c) a description of the management system; d) a statement of specific actions to be taken prior to shipment DESIGN ASSESSMENT The BfE and the BAM carry out the comprehensive safety assessment. They assess the Package Design Safety Report of a design with respect to compliance with the legal requirements. Depending on the package design, the BfE determines the mode and extent of the assessment in consultation with the BAM. The BfE summarizes the results of the complete procedure. 16 Paragraph 805 in the 2012 Edition of SSR-6. 11

12 3.4.4 DESIGN APPROVAL The BfE grants the design approval, if the design assessment has been concluded with positive results. The approval certificate is generally issued for a validity period of five years. A deviation from this validity period may be requested by the applicant. This application needs to be substantiated. The validity period of the design approval will be extended upon application if the legal regulations have not changed substantially and safety related objections against an extension of the validity period are not raised, either. The BfE maintains a register of the design approval certificates. The BfE has the exclusive right to publish design approval certificates (including extracts of such certificates). 4 FEES Design and safety assessment and approval are subject to fees. The applicant shall bear the costs incurred. The amount of costs for the activities of the BAM are determined by the relevant national ordinance Kostenverordnung für Maßnahmen bei der Beförderung gefährlicher Güter (GGKostV) as amended. The hourly rates for the cost calculation for the BfE are determined in the current version of the Dienstanweisung über die Erhebung von Gebühren und Auslagen für Amtshandlungen des BfS (DA-Amtshandlungen). 12

13 Kontakt: Bundesamt für kerntechnische Entsorgungssicherheit Krausenstraße Berlin Zweiter Dienstsitz: Willy-Brandt-Straße 5, Salzgitter Telefon: Internet: info@bfe.bund.de (kostenpflichtig): info@bfe.d .de Gedruckt auf Recyclingpapier aus 100% Altpapier