Department Safety of Nuclear Waste Management

Guideline for the design approval procedure of packages for the transport of radioactive material, of special form radioactive material and low dispersible radioactive material R 003 Department Safety of Nuclear Waste Management

Salzgitter, November 2012

Guideline for the design approval procedure of packages for the transport of radioactive material, of special form radioactive material and low dispersible radioactive material R 003 Department Safety of Nuclear Waste Management 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 und gering dispergierbaren radioaktiven Stoffen - R 003 - published in Verkehrsblatt des Bundesministers für Verkehr, Bau- und Wohnungswesen (BMVBW) of 17 November 2004 (VkBl. Heft 23, S. 594, 2004). The translation has been prepared by staff members of the Department SE 1.1 Transporte of the Federal Office for Radiation Protection (Bundesamt für Strahlenschutz), Salzgitter, Germany.

CONTENTS 1 SCOPE...4 2 COMPETENT AUTHORITIES IN THE FEDERAL REPUBLIC OF GERMANY...5 2.1 DESIGNS OF PACKAGES FOR THE TRANSPORT OF RADIOACTIVE MATERIAL...5 2.2 DESIGNS OF SPECIAL FORM RADIOACTIVE MATERIAL AND LOW DISPERSIBLE RADIOACTIVE MATERIAL...5 3 DESIGN APPROVAL PROCEDURE...5 3.1 APPROVAL OF DESIGN OF PACKAGES FOR THE TRANSPORT OF RADIOACTIVE MATERIAL...5 3.1.1 APPLICATION... 5 3.1.2 APPLICATION DOCUMENTS... 5 3.1.3 DESIGN ASSESSMENT... 7 3.1.4 DESIGN APPROVAL... 8 3.2 VALIDATION OF FOREIGN PACKAGE DESIGN APPROVALS...8 3.2.1 APPLICATION... 8 3.2.2 APPLICATION DOCUMENTS... 8 3.2.3 SAFETY ASSESSMENT... 9 3.2.4 VALIDATION... 9 3.3 DESIGN APPROVAL OF SPECIAL FORM RADIOACTIVE MATERIAL AND LOW DISPERSIBLE RADIOACTIVE MATERIAL...9 3.3.1 APPLICATION... 9 3.3.2 APPLICATION DOCUMENTS... 10 3.3.3 DESIGN ASSESSMENT... 10 3.3.4 DESIGN APPROVAL... 10 4 FEES...11 3

1 SCOPE This guideline explains the Ordinance on the Domestic and International Carriage of Dangerous Goods by Road and Rail Verordnung über die innerstaatliche und grenzüberschreitende Beförderung gefährlicher Güter auf der Straße und mit Eisenbahnen (Gefahrgutverordnung Straße und Eisenbahn GGVSE); the Ordinance on the Carriage of Dangerous Goods by Sea Verordnung über die Beförderung gefährlicher Güter mit Seeschiffen (Gefahrgutverordnung See GGVSee), the Ordinance on the Carriage of Dangerous Goods by Inland Waterways Verordnung über die Beförderung gefährlicher Güter auf Binnengewässern (Gefahrgutverordnung Binnenschifffahrt GGVBinSch); and the Regulations on Certification and Licencing in Aviation Luftverkehrs Zulassungs Ordnung; 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 Safety Standards Series No. TS-R-1 of the International Atomic Energy Agency (IAEA), for all designs of Type C, B(U), B(M) packages for radioactive material; Type CF, B(U)F, B(M)F, AF and IF packages for fissile material; packages for non-fissile or fissile excepted uranium hexafluoride (Type H(U), H(M)); special form radioactive material; and low dispersible radioactive material. 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. 4

2 COMPETENT AUTHORITIES IN THE FEDERAL REPUBLIC OF GERMANY 2.1 DESIGNS OF PACKAGES FOR THE TRANSPORT OF RADIOACTIVE MATERIAL 2.1.1 The Federal Office for Radiation Protection (Bundesamt für Strahlenschutz (BfS) 2 ) is responsible for the design approval of Type C, B(U), B(M) packages and Type CF, B(U)F, B(M)F, AF and IF packages for fissile material. 2.1.2 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)). 2.1.3 BfS is responsible for the validation of foreign package design approvals. 2.2 DESIGNS OF SPECIAL FORM RADIOACTIVE MATERIAL AND LOW DISPERSIBLE RADIOACTIVE MATERIAL BAM is responsible for the design approval of special form radioactive material and low dispersible radioactive material. 3 DESIGN APPROVAL PROCEDURE 3.1 APPROVAL OF DESIGN OF PACKAGES FOR THE TRANSPORT OF RADIOACTIVE MATERIAL 3.1.1 APPLICATION The application for a package design approval according to section 2.1.1 above should be sent to BfS 4 in duplicate including all documents as required under section 3.1.2. One copy will be sent to BAM by BfS. The application for a package design approval according to section 2.1.2 above should be sent to BAM 4 in duplicate including all documents as required under section 3.1.2. One copy will be sent to BfS by BAM. BfS and 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. 3.1.2 APPLICATION DOCUMENTS The application documents must include at least the information required by the applicable paragraphs 5 of TS-R-1 6. Compliance with all applicable requirements for the requested design approval shall be demonstrated by providing a Package Design Safety Report. The Package Design Safety Report must include in particular: a) the modes of transport for which a design approval is requested together with the relevant dangerous goods transport regulations; 5

b) a detailed description of the proposed radioactive contents including the following information, as applicable: nuclides/nuclide composition, activity and mass, physical and chemical state, geometric shape, arrangement, irradiation parameters, materials of manufacture, nature and characteristics of the radiation emitted, heat capacity to be dissipated and mass of fissile material; c) 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 detailed description of the design and its components, i.e. the complete drawings, parts lists, material specifications and a description of the overall packaging concept, the packaging body, the packaging inserts, the containment system including the pertinent components, the components required for shielding, the components of the confinement system to ensure subcriticality, the transport concept including any devices required for the safe handling, transshipment and securing in or on the conveyance, the protection against corrosion, the protection against contamination and the impact limiting components; e) the safety demonstration showing plausibly that the design meets all the requirements of the applicable regulations according to a) above. The safety demonstration shall be based on the structures of the applicable regulations listed under section 1 above 7. The demonstration has to cover in particular: demonstration of mechanical stability for routine, normal and accident conditions of transport for the components of the containment system, the components of the shielding, the components of the confinement system for ensuring subcriticality and the attachments for lifting by crane and for transport on public traffic routes, demonstration of thermal behaviour for routine, normal and accident conditions of transport including an evaluation of thermal stresses and the thermal behaviour of the components of the containment system, the components of the shielding and the components for ensuring subcriticality, demonstration that the limits for the release of radioactive material for normal and accident conditions of transport are met, demonstration that for the maximum radioactive contents the dose rate limits for normal and accident conditions of transport are met, for fissile material demonstration of subcriticality for routine, normal and accident conditions of transport; 6

f) the quality assurance and monitoring programme for design, manufacturing, documentation and 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 and in-transit storage; g) in the case of an application for design approval of Type B(M) and B(M)F packages 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, and the range of ambient conditions (temperature, insolation) for which the package is designed. The safety demonstration of a design can be accomplished by using the results of tests performed with prototypes or models of appropriate scale, by reference to previous satisfactory demonstrations of a sufficiently similar nature, by calculation, when the calculation procedures are generally agreed to be suitable and conservative or by a combination of these test methods. Reference to test results of designs similar to the design for which approval is requested is permissible if the similarity can be demonstrated sufficiently by justification and validation. If computer codes are used for safety demonstration it is up to BfS and 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, BfS and BAM may require proofs of qualification for staff members performing the calculations. 3.1.3 DESIGN ASSESSMENT BfS and BAM carry out the comprehensive safety assessment of the design (design assessment). They assess the safety demonstration of a design with respect to compliance with the regulations listed under section 1 above. In detail, BAM carries out the safety assessment with respect to the mechanical and thermal design, the release of radioactive material and quality assurance. Required tests with prototypes, models or single components are performed by BAM. BAM may accept tests conducted by other laboratories, provided that such laboratories can prove that they meet the requirements under DIN EN ISO/IEC 17025 8 as amended. For designs according to section 2.1.1 above BAM summarizes the results of the design assessment in an assessment report. BfS carries out the safety assessment with respect to shielding, criticality safety, material assignment (LSA, SCO, LDM 9 ) and compliance with the activity limits concerning the radiological properties. For designs according to section 2.1.2 above, BfS summarizes the results of the design assessment with respect to shielding and material assignment in an assessment report. 7

The assessment reports may contain suggestions for additional conditions for the design approval, if necessary. The competent authority for design approval as listed under section 2 above summarizes the results of the complete procedure and issues the design approval certificate. 3.1.4 DESIGN APPROVAL Design approval is granted if the design assessment has been concluded with positive results. The approval certificate is generally issued for a validity period of three years. The competent authority may consider a deviation from this validity period if the applicant requests any other validity period and substantiates such request. The validity of the approval certificate will be extended upon application if the legal regulations have not changed materially and safety related objections against an extension of the validity period can not be 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 quality assurance and monitoring programme. 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 BfS and BAM maintain a register of the design approval certificates issued by them, which they transmit to IAEA. BfS and BAM have the exclusive right to publish design approval certificates (including extracts of such certificates). 3.2 VALIDATION OF FOREIGN PACKAGE DESIGN APPROVALS 3.2.1 APPLICATION The application for validation of a foreign package design approval should be sent to BfS 4 in duplicate including all documents as required under section 3.2.2. One copy will be sent to BAM by BfS. BfS and BAM acknowledge receipt of the application and carry out the safety assessment. Applications will generally be processed in chronological order based on the date of receipt of the complete application documentation. 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 10 ; 8

e) a German translation 10 of the quality assurance and monitoring programme 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/reinspection 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) and B(M)F packages 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 and the package design does not meet which are valid at the time of the application. 3.2.3 SAFETY ASSESSMENT BfS and BAM carry out the safety assessment. They assess the safety demonstration of a design with respect to compliance with the regulations listed under section 1 above. Depending on the package design, BfS determines the mode and extent of the assessment in consultation with BAM. BfS summarizes the results of the complete procedure and issues the validation certificate. 3.2.4 VALIDATION Validation is granted 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. BfS maintains a register of the validation certificates, which it transmits to IAEA. BfS has the exclusive right to publish validation certificates (including extracts of such certificates). 3.3 DESIGN APPROVAL OF SPECIAL FORM RADIOACTIVE MATERIAL AND LOW DISPERSIBLE RADIOACTIVE MATERIAL 3.3.1 APPLICATION The application for a design approval of special form radioactive material should be submitted to BAM including all documents as required under section 3.3.2 in one copy. The application for a design approval of low dispersible radioactive material should be sent to BAM 4 in duplicate including all documents as required under section 3.3.2. One copy will be sent to BfS by BAM. BAM and, if involved, BfS acknowledge receipt of the application. Applications will generally be processed in chronological order based on the date of receipt of the complete application documentation. 9

3.3.2 APPLICATION DOCUMENTS The application documents must include at least the information required by the applicable paragraphs 11 of TS-R-1 6. 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; d) information on the proposed scope of application; e) documentation of performed tests 12 to show that the requirements are met (e.g. test reports for ISO classification tests for special form radioactive material); f) the quality assurance and monitoring programme for manufacturing and use for all manufacturers indicated as required under section a) above, including the specification of appropriate leakage tests. 3.3.3 DESIGN ASSESSMENT BAM and, for low dispersible radioactive material, BfS carry out the comprehensive safety assessment of the design (design assessment). They assess the safety demonstration of a design with respect to compliance with the requirements set out in the regulations. In detail, BAM carries out the safety assessment with respect to mechanical and thermal design, release of radioactive material and quality assurance. If necessary, this may include the performance of tests with prototypes. For low dispersible radioactive material BfS carries out the safety assessment with respect to the radiation level and summarizes the results of the design assessment in an assessment report. The assessment reports may contain suggestions for additional conditions for the design approval, if necessary. BAM summarizes the results of the complete procedure and issues the design approval certificate. 3.3.4 DESIGN APPROVAL Design approval is granted if the design assessment has been concluded with positive results. The approval certificate is generally issued for a validity period of five years. The competent authority may consider a deviation from this validity period if the applicant requests any other validity period and substantiates such request. The validity of the approval certificate will be extended upon application if the legal regulations have not changed materially and safety related objections against an extension of the validity period cannot be 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. BAM maintains a register of the design approval certificates, which it transmits to IAEA. BAM has the exclusive right to publish design approval certificates (including extracts of such certificates). Translator s note: This bullet point has been assigned twice in the German publication. 10

4 FEES Fees arising from design and safety assessment and certification are charged to the account of the applicant and are calculated on a time basis according to the institutions internal procedures for charging fees, i.e. the current version of the BfS Dienstanweisung über die Erhebung von Gebühren und Auslagen and the BAM Kostenverordnung, both based on the relevant national ordinance Kostenverordnung für Maßnahmen bei der Beförderung gefährlicher Güter (GGKostV). 1 [comment on exact wording not applicable to English version] 2 Bundesamt für Strahlenschutz, Postfach 10 01 49, D-38201 Salzgitter 3 Bundesanstalt für Materialforschung und prüfung, D-12200 Berlin 4 It is also allowed to send one copy of the application including the required documents to each of the institutions, i.e. BfS and BAM. This procedure must be indicated in the application. 5 Paragraphs 805(b), 807, 810 and 813 in the revised 1996 edition of TS-R-1. 6 For simplification it is referred to IAEA regulation TS-R-1 instead of referring to all regulations concerning the different modes of transport listed under section 1. 7 In the case of an extensive Package Design Safety Report a summary report shall be provided stating the results according to the structure of the applicable legal regulations. This summary report shall contain reference to the detailed demonstrations. 8 DIN EN ISO/IEC 17025 Allgemeine Anforderungen an die Kompetenz von Prüf- und Kalibrierlaboratorien General requirements on the competence of testing and calibration laboratories 9 LSA: low specific activity material SCO: surface contaminated object LDM: low dispersible radioactive material 10 In consultation with BAM, BfS may agree to wholly or partially dispense with a translation. 11 Paragraph 803 in the revised 1996 edition of TS-R-1. 12 In case of computer code application for safety demonstration the provisions set out in section 3.1.2 apply accordingly. 11

Verantwortung für Mensch und Umwelt Kontakt: Bundesamt für Strahlenschutz Postfach 100149 38201 Salzgitter Telefon: + 49 30 18333-0 Telefax: + 49 30 18333-1885 Internet: www.bfs.de E-Mail: epost@bfs.de Gedruckt auf Recyclingpapier aus 100% Altpapier