ML24304B050

Enclosure - Safety Evaluation Report Revalidation Recommendation for the French Certificate of Approval No. F/410/B(U)-96, Revision Bi for the Model No. Manon Package, Docket No. 71-3094

ML24304B050
Person / Time
Site:	07103094
Issue date:	11/12/2024
From:	Storage and Transportation Licensing Branch
To:
Shared Package
ML24304B048	List: ML24304B049 ML24304B050
References
EPID L-2023-DOT-0007
Download: ML24304B050 (1)

Text

Enclosure UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 SAFETY EVALUATION REPORT Docket No. 71-3094 Model No. MANON Package French Certificate F/410/B(U)-96 Revision Bi

SUMMARY

By letter dated April 6, 2023 (Agencywide Documents Access and Management System Accession No. ML23251A205) as supplemented on April 24, 2024 (ML24312A201), the U.S.

Department of Transportation (DOT) requested that the U.S. Nuclear Regulatory Commission (NRC) staff perform a review of the Certificate of Competent Authority No. F/410/B(U)-96 Revision Bi, Model No. MANON. In your application you requested that the NRC provide a recommendation to revalidate the Model No. MANON package for import and export use.

Specifically, you requested that the NRC only review the content in appendix 3 to the French certificate, specifically the Gisete 4 isotope generator.

The NRC reviewed the information provided to DOT by Orano TN (the applicant) in its application for the Model No. MANON package against the regulatory requirements of the International Atomic Energy Agency (IAEA) Specific Safety Requirements No. SSR-6, Regulations for the Safe Transport of Radioactive Material, 2012 Edition (SSR-6 or the Regulations). Based on the statements and representations in the information provided by DOT and the applicant, the staff recommends the revalidation of the French Certificate of Approval F/410/B(U)-96, for the Model No. MANON package, for shipment as described in this safety evaluation report (SER). The staff notes, however, that the application does not provide any calculation to demonstrate that the package meets the tie down system design requirement using acceleration factors in the SSG-26, Table IV.2.

1.0 GENERAL INFORMATION The packaging for shipment of the Gisete 4 isotope generator consists of either an Internal Enclosure Assembly (EDCI) or an External Enclosure Assembly (EDCE) with shims inside of a casing. The casing is comprised of the upper and lower shell and shock absorber.

1.1 Contents The package contents consist of a Gisete 4 radioisotope thermal generator (RTG), which may contain a maximum of 203 TBq of the three sources: Cobalt-60, Cesium-137, and Strontium-90, producing less than or equal to 37 W of decay heat.

2.0 STRUCTURAL EVALUATION The objective of the structural evaluation is to verify that the structural performance of the package meets the requirements of the IAEA SSR-6, 2012 Edition. This revision of the package is for the transport of the Gisete 4 isotope generator, complying with the IAEA requirements on radioactive material Type B(U) transportation.

2 2.1 Description of Structures The MANON series of packages are comprised of a standardized casing with an attached shock absorbing system. The space within the casing can accommodate a variety of payloads. The payloads are secured in place within the casing with the help of either an EDCI or an EDCE with shims. The safety analysis report (SAR) figure 3.8 shows the configuration for this revision of the Manon package with the Gisete 4 payload within the EDCE secured by a K3 shimming system. The proposed Manon package for the Gisete 4 content is a Type B(U) package designed to transport a strontium RTG, which is designated as non-removable equipment. The package has the following principal structural components: casing, EDCE, Non-removable Equipment (AI) /radioisotope generator (i.e., Gisete 4), and the internal shimming to secure the non-removable equipment. Detailed descriptions of the structural components are provided in chapter 03, DESCRIPTION OF THE PACKAGING, of the SAR. The following are the summarized descriptions of the safety significant components.

Casing: The casing is a two-piece shock absorbing system including upper casing and lower casing. Each half of the casing comprises three sub-assemblies including the shell, foam covered with stainless sheathing, and handling elements. It provides the mechanical protection for the EDCE. The shell is cylindrical in shape and made of stainless steel. The foam inside the sheathing is made of phenolic foam DL NU280h, which provides the shock-absorption function. The handling elements in the form of trunnions provide the lifting attachments for the casing. The overall external dimensions of the casing are 2,550 mm in diameter and 2,570 mm in height. The mass of the casing is approximately 5,487 kg. Appendix 4 in chapter 03 of the SAR provides the mass balance for other structural components.

External Enclosure Assembly: The EDCE is used to provide containment for the non-removable equipment and is placed inside the casing. It is comprised of three sub-assemblies: a body, a lid, and a shimming system. The body is made up of 2 stainless steel pieces in cylindrical shape, and a layer of phenolic foam between 100 mm and 154 mm for shock absorbing and thermal protection. The overall dimensions of the EDCE are 1,780 mm in diameter and 1,672 mm in height. The maximum mass of the empty EDCE is approximately 2,148 kg.

Internal shimming system: The shimming system for Gisete 4 includes a lower and an upper shimming system named as K3. The total maximum mass of the K3 shimming system is 373 kg.

Non-removable Equipment (AI): The overall dimensions of the Gisete 4 90Sr isotope generators are 853 mm in diameter and 865 mm in height. The maximum mass of Gisete 4 is 2,270 kg.

The applicant provided the general casing with an empty EDCE diagram in appendix 0, figure 0.4, in the SAR. The applicant also provided the diagram of the Gisete 4 non-removable equipment of the Manon transportation package in appendix 3, figure 3.7, in the SAR. The total mass for the casing, EDCE, shimming system, and the Gisete 4 isotope generators is 10,278 kg.

The staff reviewed the designs for completeness and accuracy and found that the geometry, dimensions, material, components, notes, and fabrication details were adequately described.

3 2.2 Structural Analyses 2.2.1 Strength Analysis of the Containment Enclosures The applicant performed a structural analysis to demonstrate the strength of the enclosures in the package comprising the Non-removable Equipment, EDCE screws, closure plate screws, and the EDCE when they are subjected to pressures under normal conditions of transport (NCT) and accident conditions of transport (ACT) and during the lifting process. The fatigue induced strength reduction is also considered in the analysis.

The applicant considered the following design criteria per IAEA SSR-6 requirements:

(a). A maximum normal operating pressure (MNOP) lower than the pressure of 700 kPa (IAEA SSR-6-2012, §664).

(b). An ambient pressure reduction to 60 kPa (IAEA SSR-6-2012, §645, 652) during which the enclosure must retain the radioactive content.

(c). an external overpressure of 150 kPa, following an immersion test (IAEA SSR-6-2012, §729).

The applicant used the ANSYS finite element (FE) computer program to build the structural models of EDCE by using 8-node linear solid elements for a 20 mm plate to which the lifting points are attached and 4-node linear shell elements for the rest of the EDCE. This model is used for calculating the induced stresses in the structure subjected to the required pressures under NCT and ACT and during the lifting process. A comparison study by the applicant is conducted to validate that the degree of freedom discontinuity between the shell element to solid element led to a conservative stress result. The staff considered this modeling approach acceptable.

For fatigue effect, the stresses of the EDCE structure are checked for a permissible stress of the structural component material during lifting, when the ambient pressure decreases to 60 kPa under NCT or ACT, or when the ambient pressure increases to 150 kPa (immersed to 15 m).

The maximum stress and the allowable stress are shown in table 13 and table 14 in section 6.5.3 of chapter 04-03 for screwed connection and enclosure components respectively. The results showed that the induced stresses on all enclosure components were below permissible stress limits. The results also show that the bolts prestress is adequate for the imposed load.

Therefore, the bolts remain in tension, which indicates that the fastening bolts of the lids and closure plates on the EDCE provide the required leak tightness. The staff found that the enclosures can withstand a lowering ambient pressure down to 60 kPa and withstand an increasing external pressure up to 150 kPa. Therefore, the IAEA requirements are met.

2.2.2 Strength Analysis of the Tie-Downs, Handling Devices, Lifting Components and Stacking The applicant performed a structural analysis to determine the strength of the tie-downs, handling devices, lifting components and stacking. The applicant utilized the ANSYS FE computer program and manual calculation for different structural components. Descriptions of the FE structural modeling with the analytical assumptions and design criteria are provided in chapter 04-02 of the SAR.

4 In section 5.3 - HANDLING - LIFTING of chapter 04-02 of the SAR, tables 1, 2 and 3 provide the results of the FE structural analysis for the calculated stress at the lifting points of the casing and EDCE, the calculated stresses for the handling systems, and the calculated stresses on removable components, respectively. In section 5.3.3, manual calculations for casing and EDCE lifting devices are provided. The staff reviewed the results which show that all calculated stresses are less than the material yield stress per IAEA SSG-26, Para IV.8. The staff concluded that the lifting design meet the IAEA requirements.

In section 5.4 - STRENGTH OF THE TIE DOWN LUGS IN ROUTINE CONDITIONS OF TRANSPORT of chapter 04-02 of the SAR, tables 9 and 10 provide the results for the tie down lugs and casing shell in normal transportation condition including the fatigue condition. The lug welds are also evaluated in section 5.4.7 and 5.4.9 for normal transportation conditions and fatigue conditions. The results show that all calculated stresses are less than the material yield stress per IAEA SSG-26, Para IV.8, for the tie down system using the acceleration factors recommended for most international transport in table IV.1 of the IAEA Specific Safety Guide SSG-26, Revision 0. However, according to the IAEA SSG-26, Para IV.12, the package designer is responsible for ensuring that the package tie down attachment points are designed in compliance with values acceptable to the relevant competent authorities and defined in modal requirements. This requires the use of acceleration factors recommended in table IV.2 of the IAEA SSG-26 for U.S. transportation, which is consistent with the U.S. regulatory requirement Title 10 of the Code of Federal Regulations (10 CFR) Section 71.45(b)(1). The staff found that the SAR does NOT provide any calculation to demonstrate that the package meets the tie down system design requirement using acceleration factors in the SSG-26, table IV.2.

In Section 6 - STACKING of chapter 04-02 of the SAR, the applicant provides a buckling analysis and its result for the packaging. The IAEA SSR-6 requires that the Manon packaging be subjected to the greater of five times the mass of the package or 13 kPa times the vertical projected area of the package. Using the greater of these two, the applicant calculated an allowable buckling load of 2.8x108 N, which is more than 300 times the load induced by the stacking of five packages (735,750 N). Based on the calculation provide in the SAR, the staff concluded that the Manon transportation package meets the IAEA requirements for the stacking.

The staff reviewed the analysis results submitted by the applicant. The staff concluded that the package components (i.e., tie-downs, handling devices, lifting components, and other elements) have adequate strength to meet the requirement of IAEA SSR-6 except for the tie down devices.

2.3 Normal and Accident Conditions of Transport Due to the largest mass and its associated largest drop energy of Marguerite 20 among all Non-removable Equipment, the Marguerite 20 package is selected as a representative of all AI packages for all test scenarios. Both analytical and 1/3 scale prototype analyses are performed for the package drop test under NCT and ACT conditions. The tests were planned and carried out in accordance with the requirements of IAEA SSR-6.

The applicant performed three types of simulated drop tests using FE analysis in LS-DYNA.

These tests include Type 1, under NCT: drop from a height of 0.6 meter (m); Type 2, under ACT condition: drop from a height of 9 m; and Type 3, under ACT: drop onto a bar from a height of 1

m. Various configurations are studied (corner, edge, with or without whiplash) to evaluate the harshest conditions. Different structural components and bolt performance are checked. The results are in section 6 of chapter 04-03 of the SAR. In section 7 of chapter 04-03 of the SAR,

5 the applicant concluded that the damage is limited to various degrees of deformation to the protective enclosure and shimming system only, with no rupture at the containment enclosure closing system, and EDCE sources and contents are free from external aggression.

The applicant also performed a total of fifteen (15) drop tests using the 1/3 scale model to demonstrate the structural integrity and performance of the package under NCT and ACT. Five (5) tests were under NCT, and ten (10) tests were under ACT. The free fall drop test heights onto a flat target were 0.68 m and 9.76 m for NCT and ACT, respectively, and the height for the drop onto a bar for ACT was 1.07 m. The drop test orientations were chosen to cause maximum damage to the package. Chapters 04-04 and 04-05 of the SAR provide detailed information for the drop test program.

The applicant provided a summary of the drop test results in chapter 04-06 of the SAR, which compares favorably with the analytical test results. Based on the results of the tests in the SAR, the staff concluded that the sources and non-removable equipment in the Manon package will not undergo any structural functional failures under NCT and ACT.

2.4 Evaluation Findings

Based on a review of the statements and representations contained in the application, the staff finds that the structural designs of the components of the Manon transportation package meet the structural requirements of the IAEA SSR-6, 2012 edition, with exception of the tie down system. The tiedown system design does NOT fulfill the requirement using acceleration factors for the US transport per table IV.2 of the IAEA SSG-26.

3.0 THERMAL EVALUATION 3.1 General Considerations MANON is a Type B(U) package designed to transport specified strontium isotope generators, which are designated in the application as non-removable equipment. The package consists of the MANON casing, the External Enclosure Assembly (EDCE) placed within the MANON casing, non-removable equipment/isotope generator (e.g., Gisete 4 with Strontium-90 source) within the EDCE, and the internal shimming to secure the non-removable equipment and EDCE.

Chapter 04-07 section 6 indicated that the MANON package is transported for non-exclusive use. The focus of this revalidation is the transport of the Gisete 4 isotope generator. According to the French certificate (F/410/B(U)-96 (3i)), the package is transported in a vertical position.

3.2 Thermal Design Features According to chapter 03, the Gisete 4 isotope generator content is placed within an EDCE, which is placed within the cavity of the MANON casing. A stainless-steel shimming system is part of the EDCE to secure the non-removable equipment. The casing cylindrical enclosure and the EDCE enclosure consist of stainless-steel half-shells. Phenolic foam (DL NU280h) is placed around the MANON casing and, for the EDCE, is located axially and injected onto the radial portion with stainless steel plates covering the foam. Details of the packages phenolic foam were provided in document NOT 0301 Rev 01 MANON CASING Technical Specifications for MANON casing phenolic foam. There is no mechanical cooling system.

According to chapter 03, the MANON casing and the phenolic foam associated with the MANON casing and EDCE provide thermal protection at the high temperatures of the hypothetical fire accident. Thermal properties of the foam and stainless-steel components,

6 including density, specific heat, and thermal conductivity, were provided in Note on Thermal Calculations (NC LME 50291001-08 rev. C), which indicated that the foam properties were referenced in document DSTM9665 Rev. A NU280H.

Chapter 03 indicated that the welds associated with the casing and the EDCE are noted in the drawings and are based on NF EN ISO 15607 (or equivalent). The welds of the EDCE containment are full penetration and a tensile test is carried out on representative samples of each welding procedure. The weld filler material is based on the mechanical properties of the metals used in construction and all welds are inspected using a dye penetrant method; in addition, EDCE containment welds are inspected during fabrication by radiography or ultrasound.

According to chapter 03, both the MANON casing and the EDCE have fusible plugs (i.e.,

thermal fuses) located in their outer periphery; the fuses are holes that are filled with polyurethane mastic and pellets of polyethylene with a melting point lower than 180 °C. The thermal fuses allow water vapor from the phenolic foam to dissipate from the foam during a fire scenario to prevent pressurization of adjacent structural metal. Chapter 03 also stated the thermal fuses have a compatible temperature range between -40 °C and 70 °C. According to chapter 04-11 table 2, the thermal fuse is an important-to-safety component and must meet a certificate of conformity. Chapter 05-01 indicated that the packages systematic maintenance and minor maintenance includes checking the condition of the thermal fuses and leak testing of the of the fusible plugs associated with the MANON casing and EDCE.

3.3 Decay Heat Chapter 02 stated that non-removable content transported inside the EDCE consists of isotope generators with Sr-90 sources in the form of sintered pellets. Staff notes that the applications analyses (e.g., thermal) often were based on the bounding Marguerite 20 isotope generator, which according to chapter 2 section 6.2, has a 4000 kg mass and 1699.42 TBq activity; these values are greater than the Gisete 4 mass and activity of 2270 kg and 202.7 TBq, respectively.

Likewise, the Marguerite 20 isotope generator has a 309 W decay heat (calculated based on the year 2006), which is greater than the Gisete 4 isotope generator thermal power of 37 W (calculated based on the year 2006). Staff notes that the actual decay heat of the shipment would be further reduced from the analyzed 309 W value, considering the Gisete 4s decay heat of 37 W would have decreased during the years between 2006 and 2023.

3.4 Summary of Temperatures and Pressures Chapter 04-07 provided a summary of temperatures for NCT and ACT. A listing of the temperatures and pressures at NCT and ACT is provided below in SER section 3.5 and section 3.6.

3.5 Thermal Evaluation for Normal Conditions of Transport Chapter 04-07 indicated that the ANSYS 11 finite element analysis software was used for the thermal analysis. Although the French certificate (F/410/B(U)-96 (3i) Revision, appendix 3) indicated the package is designed to be handled, loaded, and transported in a vertical position, the document Note on Thermal Calculations (NC LME 50291001-08 rev. C) stated that analyses were made with the package being in a horizontal orientation and a vertical orientation with maximum temperatures being reported for the horizontal orientation. The three-dimensional (3-D) EDCE and MANON casing model included the shell, end plates, and phenolic foam.

7 Chapter 04-07 also indicated that the bounding 309 W decay heat was applied homogeneously to the wall of a cavity simulating the space occupied by the isotope generator.

In terms of modeling inputs and boundary conditions, the document Note on Thermal Calculations provided the density, thermal conductivity, and heat capacity of the 304L stainless steel and foam that comprise the EDCE and MANON casing. Section 6.5 indicated that the models ambient air temperature boundary condition was 38 °C. Section 6.6.2 provided the heat transfer coefficient correlations for the horizontal and vertical surfaces. Solar radiation was 800 W/m2 on horizontal surfaces and 200 W/m2 for vertical surfaces. Emissivity of the steel structure was taken as 0.2 and the solar absorptivity coefficient was 0.4.

Chapter 4-07 Thermal Study section 6 indicated that a 410 W decay heat inside the MANON casing resulted in a surface temperature of less than 50 °C, which is the regulatory limit for non-exclusive use transportation. The thermal study stated that the surface temperature would also be less than 50 °C for a confined transport condition. Note on Thermal Calculations (NC LME 50291991-08 rev. C) indicated that a routine transport condition (without insolation) of a 309 W Marguerite 20 isotope generator would result in a package surface temperature of 48 °C. Staff notes that the surface temperature when transporting a Gisete 4 isotope generator would be reduced from the analyzed condition because of its lower decay heat of 37 W.

The results in chapter 04-07 indicated that the mean temperature of the foam located in the casing protective covers is 60.2 °C, which is below the 70 °C temperature referenced in the tests described in chapter 04-04. Likewise, the mean temperature of the EDCE foam was 83.7 °C, the maximum temperature of the EDCE flange was 94 °C, and the temperatures of the EDCE gaskets were 93 °C, which is less than the limit criterion of 170 °C reported in section 8.2 of chapter 04-07. As indicated earlier, the above-mentioned package temperatures would be lower because the Gisete 4 decay heat of 37 W is much less than the 309 W analyzed value.

Regarding cold temperatures, chapter 04-08 stated that the phenolic foam retains its effectiveness at -40 °C and that the ethylene propylene diene monomer (EPDM) gaskets are guaranteed to -55 °C, per the STACEM F-DEV-04-02 Technical data sheet. Chapter 03 section 6.5.4.6 stated that the fusible plugs have a minimum allowable temperature of -40 °C.

Chapter 04-01 presented results of the MNOP analysis that considered the effect of an internal 113 °C temperature and conservatively considered the effect of radiolysis gases that can exist when transporting a rhodamine source (i.e., content in a CC33 shell and 870 L VS drum),

although the current revalidation is based on a Sr-90 source within the Gisete 4 isotope generator. The result was an MNOP of 38.4 kPa gauge pressure, (i.e., assuming a zero ambient external pressure).

3.6 Thermal Evaluation for Accident Conditions of Transport According to section 7.3 of Notes on Thermal Calculations, the transient thermal analysis applied the package temperatures at normal conditions as initial conditions. Section 6.6.3.2 indicated the emissivity of the external package surface was 0.8 during and after the 800 °C fire.

The flame emissivity was taken as 1. Section 6.6.2.2 stated that the convective heat transfer coefficient between the package and the 800 °C fire was 10 W/m2-K. After the 30-minute fire, the convection heat transfer coefficient correlations were those used during normal conditions; likewise, solar irradiation was applied during the cool-down portion of the transient.

According to section 6.2 of Note on Thermal Calculations, the thermal model considered the damage to the package after lateral drops, including reduced casing foam thickness and the

8 isotope generator being closer to the casing structure that is exposed to the fire. Section 8.2 of chapter 04-07 noted that ACT package temperatures were highest when the MANON casing and EDCE container arrangement was in the horizontal configuration.

Results from section 7.3.1, Note on Thermal Calculations, indicated that the outer package (i.e., casing) had a maximum temperature of 800 °C. In addition, gaskets reached a maximum temperature of 141 °C after 4 hour4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> 45 minutes, which is less than the 170 °C allowable temperature. Temperature transient profiles (up to 100,000 seconds) of the EDCE cavity and gasket were provided in figure 10 and indicated a cavity gas temperature of 144 °C. Section 10 of chapter 04-07 stated that lead temperatures during NCT and ACT were below the melting point. In order to determine a bounding source temperature during the fire ACT, section 8.2 of chapter 04-07 discussed a thermal analysis that conservatively assumed a 1541 W decay heat (more than twice the decay heat from a Cobalt 60 source content), resulting in a maximum package temperature of 558 °C; this showed that temperatures would be below the melting points of Co-60, Ce-137, and Strontium-90 sources (e.g., Gisete 4 isotope generator). Finally, as noted earlier, package temperatures would be lower due to the Gisete 4 decay heat of 37 W being much less than the analyzed value of 309 W.

As mentioned above, Note on Thermal Calculations figure 10 indicated that air in the enclosure assembly reached a temperature of 144 °C after 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> and 20 minutes of the ACT transient.

The applicant used the Ideal Gas Law to calculate a 1.44 bar (144,000 Pa) absolute internal pressure within the EDCE during accident conditions. Similar to the previously mentioned NCT pressure analyses, chapter 04-01 calculated an EDCE ACT pressure of 49.8 kPa (gauge) assuming a rhodamine source content that underwent radiolysis. As mentioned above, this is a conservative assumption for the current revalidation request of transporting a Gisete 4 isotope generator with a strontium source. Regarding the structural integrity of the EDCE containment boundary, section 5.5 of Chapter 04-01 indicated structural safety coefficients above 1.25 for the conditions of decreasing ambient pressure to 60 kPa (60,000 Pa) and for external overpressures of 150 kPa (150,000 Pa).

3.7 Conclusion This licensing action is a revalidation of the French certificate for the MANON package that was approved according to the IAEA SSR-6 2012 edition. Based on a review of the relevant portions of the French certificate and the representations in the application, the staff has reasonable assurance that the MANON package with the Gisete 4 non-removable equipment with a decay heat of 37 W meets the thermal requirements of IAEA SSR-6 2012 edition.

4.0 CONTAINMENT EVALUATION 4.1 General Considerations MANON is a Type B(U) package designed to transport specified strontium isotope generators, which are designated in the application as non-removable equipment. The package consists of the MANON casing, the EDCE placed within the MANON casing, non-removable equipment/isotope generator (e.g., Gisete 4 with Strontium-90 source) within the EDCE, and the internal shimming to secure the non-removable equipment and EDCE. Chapter 04-07 section 6 indicated that the MANON package is transported for non-exclusive use. The focus of this revalidation is the transport of the Gisete 4 isotope generator.

9 4.2 Description of Containment System Chapter 3 section 6.5 indicated that the MANON package relies on the EDCE as the containment boundary, which includes a stainless-steel body, stainless steel lid and screws, vent closure plate fastening on the lid, and EPDM gaskets. The body consists of 2 stainless steel shells, each shell has a flange that connect with 18 screws. Two trapezoidal grooves are machined into the upper flange to hold two EPDM O-ring gaskets. An inter-ring space between the gaskets is used to leak test the flange; a plug is positioned over the hole through the flange from the inter-ring space when leak testing is completed. A stainless-steel vent closure plate protects the self-sealing coupling on the vent and is fastened to the lid. Chapter 3 section 10.4 and appendix 6 provided information on the screws and section 10.5 stated that the surface properties in contact with the gaskets are appropriate to achieve containment. Section 10.6 provided the EPDM gasket specifications (e.g., 48DRL13 by STACEM or EP8517 by Joint Francais) and appendix 7 provided the gasket geometric design details. MANON casing and EDCE drawings (EMB/MANON/AMINT/DSS/PE 0500 Rev. A) were referenced in the French Certificate (F/410/B(U)-96 (3i)).

Chapter 03 indicated that the welds associated with the casing and the EDCE are noted in the drawings and are based on NF EN ISO 15607 (or equivalent). The welds of the EDCE containment are full penetration and a tensile test is carried out on representative samples of each welding procedure. The weld filler material is based on the mechanical properties of the metals used in construction and all welds are inspected using a dye penetrant method; in addition, EDCE containment welds are inspected during fabrication by radiography or ultrasound.

According to chapter 03 and chapter 05-01, the closure of the MANON casing includes M30 screws (30 quantity) with an 850 Nm tightening torque. Likewise, the closure arrangement of the EDCE is secured by M24 screws (18 quantity) with a 760 Nm tightening torque and EDCE closure plate M10 screws (4 quantity) with a 35 Nm tightening torque. Chapter 05-01 also indicated that safety seals are installed on the package.

4.3 Description of Content Chapter 02 stated that non-removable content, consisting of isotope generators with Sr-90 sources in the form of sintered pellets, are transported inside the EDCE. Staff notes that the applications analyses (e.g., thermal) often were based on the bounding Marguerite 20 isotope generator, which according to chapter 2 section 6.2, has a 4000 kg mass and 1699.42 TBq activity; these values are greater than the Gisete 4 mass and activity of 2270 kg and 202.7 TBq, respectively. Likewise, the Marguerite 20 isotope generator has a 309 W decay heat (calculated based on the year 2006), which is greater than the Gisete 4 isotope generator thermal power of 37 W (calculated based on the year 2006). Using the leakage rate equations provided in chapter 02, section 9.4 concluded that the intrinsic specific activity of the materials transported in the EDCE is less than the maximum specific activity calculated to meet regulatory release criteria, and based on those calculations, the permissible normalized leak rate for the EDCE is 6.2E-4 Pa m3/sec (SLR). Staff notes that the actual decay heat and activity of the shipment would be reduced from the above-mentioned values considering the smaller-sized Gisete 4 isotope generators Sr-90 pellet activity that would be actually transported would decrease during the years between 2006 and 2023.

10 4.4 Description of Containment System Performance The condition of the EDCE containment boundary after normal conditions (e.g., drop height of 0.6 m) and accident conditions (e.g., cumulative NCT and ACT drop height of 9.6 m as well as drop onto a bar from a height of 1 m) was discussed in Chapter 04-03 (Analytical study of the behaviour of the package during drop tests under NCT and ACT, DSEM 5107 Rev 02).

Specifically, section 5 indicated that there would be minimal delayed impact of the package contents from the drops because the isotope generator (i.e., bounding Marguerite 20) is wedged inside the EDCE and, likewise, the EDCE is wedged against the MANON casing via the shimming system. Table 6 indicated that, for the 9.6 m drop test, the analytical LS-DYNA calculations showed the EDCE body and lids maximum plastic strains were much less than the permissible strain limit and the EDCE flange had no plastic strain. In addition, the section 6.5.3 analyses indicated that after ACT the packaging screws met requirements of mechanical strength, non-shearing of tapped hole threads and screws, non-plastic regime of screws, and no detachment of package screws, thereby ensuring leaktightness. The document Note on Mechanical Calculations (NC LME 50291001-01 ver. B) indicated that the EDCE joining surface parts and the screws did not undergo permanent deformation, there was no separation at the EDCE interface, and that the EDCE had continued leaktightness after the drop.

Similarly, the document Note on Mechanical Calculations, External enclosure assembly for non-removable equipment, Casing for SV34, SV69 and non-removable equipment (NC LME 50291001-04 ver. B) discussed the effect of pressure loads on the EDCE structure, EDCE screws, and closure plate screws due to reduction in ambient pressure to 60 kPa and immersion to 15 m, respectively. It was noted for NCT and ACT that the reduction in ambient pressure to 60 kPa resulted in a higher load because it represents approximately two times the differential pressure at ambient condition. Analytical results for reduction in ambient pressure to 60 kPa and the results for immersion to 15 m indicated that the EDCE structure, EDCE screws, and closure plate screws can withstand the corresponding loads. For example, section 5.5 of chapter 04-01 indicated structural safety coefficients above 1.25 for the conditions of decreasing ambient pressure to 60 kPa (60,000 Pa) and for external overpressures of 150 kPa (150,000 Pa).

Finally, the Note on Thermal Calculations (NC LME 50291001-08 Rev. C) stated that the maximum gasket temperature during the fire ACT was 144 °C, which was below the 170 °C allowable temperature reported in Chapter 04-07.

Chapter 04 section 6.1 noted that the isotope generator non-removeable equipment provides radiological protection and confines the Sr-90 source pellets. Likewise, although chapter 04-10 Analytical study of the behavior of the package during drop tests under NCT and ACT (DSEM 5107 Rev 02) indicated the Marguerite 20 isotope generator (which bounds the Gisete 4 isotope generator) within the EDCE is not damaged during the drop tests, confinement credit was not taken for the isotope generators presence, such that the containment release calculations conservatively assumed a suspended aerosol volume concentration of Sr-90 would transfer from the isotope generator into the EDCE. Chapter 4-11 stated that the allowable leakage rate test limit for the MANON package transporting the EDCE was 6.2E-4 Pa m3/sec (SLR). This value was based on the chapter 4-11 analysis showing this leakage rate would result in releases that remain below the regulatory limits of 10E-6 A2/hr at NCT and an A2/week at ACT.

According to chapter 05-01 section 6, systematic maintenance of the MANON casing and EDCE is performed prior to each transport. For example, the condition of the EDCEs EPDM gaskets is checked and the gaskets are replaced beyond 30 cycles of use or if they are not within

11 specification. Although not listed in the systematic discussion of section 6.2, it is noted that a pre-shipment leakage rate test is performed after loading of the isotope generator in the EDCE.

Specifically, section 5.6.1 of chapter 05-01 indicated that, as part of loading, the air leakage testing of the gasket interspace (e.g., lid/flange gaskets and closure plate/gaskets) is performed with the overall acceptance criteria of 6.2E-4 Pa m3/sec, as described in the chapter 05-01 appendix. [Staff notes that leakage test rates are typically denoted at normalized SLR conditions, according to chapter 04-10.] Minor maintenance of the MANON casing and EDCE is performed every 3 years or 30 cycles, consisting of systematic maintenance and replacement of all gaskets and inspection of mating surfaces. In addition, the chapter 05-01 Appendix indicates that leak testing is performed on the EDCE containment enclosure welds to an overall criterion less than 1E-5 Pa m3/sec. Major maintenance of the MANON casing and EDCE is performed every 6 years or 60 cycles and consists of the systematic maintenance and minor maintenance activities as well as a helium leak test of the containment enclosure welds with an overall acceptance criterion of less than 1E-8 Pa m3/sec. Details of the packages air and helium leakage rate test procedures were provided in the appendix to chapter 05-01. In addition, chapter 03 section 12.6 provided additional leak test details; for example, the leak rate test of the internal gaskets of the EDCEs containment flanges and the vent orifice closure plates use a pressure rise test method whereas the leak rate of the containment enclosure welds during fabrication is measured using an integral vacuum helium leak test. As noted in chapter 05, chapter 05-01, and chapter 05-02, package use and qualifications (e.g., leakage rate) are performed as part of the certified ISO 9001 quality assurance system. For example, section 8 of chapter 04-05 Drop Test program noted that leak tests are performed by qualified personnel with COFREND certification.

4.5 Conclusion This licensing action is a revalidation of the French certificate for the MANON package that was approved according to the IAEA SSR-6 2012 edition. Based on a review of the relevant portions of the French certificate and the representations in the application, the staff has reasonable assurance that the MANON package with Gisete 4 non-removable equipment content with a decay heat of 37 W meets the containment requirements of IAEA SSR-6 2012 edition.

5.0 CRITICALITY This package does not include transportation of any fissile material. Thus, no criticality evaluation was performed.

6.0 SHIELDING The staff reviewed the revalidation of French Competent Authority Certificate F/410/B(U)-96 for the Model No. MANON Cask (MANON Cask) to ensure that the shielding is adequate to meet the radiation level requirement within the IAEA SSR-6, 2012 Edition (IAEA 2012a) for protecting people and the environment, for this type of package. Specifically, staff verified compliance with the requirements of paragraphs 523, 526, 527, 648(b), and 659(b)(1).

6.1 Shielding Design Features The staff reviewed the information related to the shielding components of the packaging of the MANON Cask which consist of the following components: a cylindrical external mechanical protection, including two half-shells, an upper and a lower one, made of stainless-steel plating and each composed of a shell welded to a disc forming the bottom, and an identical shock

12 absorbing systems for both half-shells made up of phenolic foam. These shock absorbers have the general shape of a ring, into which a recess is machined to create an overlapping zone for the protective shell. A schematic diagram of the tie-down system is shown in figure 0.5 of the application.

The packaging consists of a casing with three possible types of contents: waste, sources, and non-removable equipment (AI). The contents are transported in the following containers: SV34 equipped with an EDCI, SV69 container, and the EDCE, which could be non-removable equipment in either CC33 shell or, 870L VS drum, and the sources transported in the SV34 and SV69 containers are either Co-60 or Cs-137 sources. The contents to be transported are Co-60 and Cs-137 sources, placed in source baskets.

6.2 Radioactive Materials and Source Terms 6.2.1 Radioactive Materials The maximum permissible activity of the sources is 980 TBq for Co-60 and 3,150 TBq for Cs-137. The two types of sources can be mixed if the total heat output does not exceed 410 W and the total activity does not exceed 3150 TBq. The non-removable equipment (AI) consists of Sr-90 isotope generators. The sources transported in the CC33 shell are Sr-90 sources. The maximum permissible activity of the sources is 173 TBq. The contents of the 870 L VS drums consist of solid waste in metal primary packaging (boxes, canisters, metal containers, etc.)

blocked in the drum by a concrete-type immobilization mortar.

Description of the SV34, SV69, and EDCE configurations are described in section 6.2 of the application. For the SV34 container, the applicant considered to place an EDCI inside the cavity of each SV34 container model. The SV34 container is placed inside the MANON package with an interface, which is a shimming system consisting of an upper part and a lower part. For the SV69 container, the applicant considered to place it inside the MANON package with an interface, which is a shimming system consisting of an upper part and a lower part. To provide an overall leakage rate measurement, the SV69 container is fitted with a new lid. For the EDCE container, it can hold an item of non-removable equipment, a CC33 shell containing a source or an 870 L VS drum.

The SV34 container is cylindrical in shape with a vertical centerline. It is composed of a stainless-steel body, shielding made of lead and depleted uranium (radiological protection), and an EDCI. To be able to replace the gaskets of the SV34 container in the "packaging loaded" configuration, an EDCI is placed inside the SV34 cavity. This EDCI is slid into the internal cavity of the SV34 and secured using the interfaces of the old plug. The SV69 container is cylindrical in shape with a vertical centerline. It consists of lead shielding. It is made up of elements such as a body, a lead plug, a stainless-steel securing plate, a shock absorbing cover made of poplar and balsa.

6.2.2 Source terms For the SV34 and SV69 containers, they hold sources of Co-60 and CS-137. For the calculation method of these isotopes, the applicant performed calculations based on the maximum activity of the sources as follow: for Co-60: 3700 TBq, and for Cs-137: 7400 TBq. The following spectra used for the calculations: Co-60 spectrum: two gamma rays of 1.17 and 1.33 MeV with a 100 percent yield, and Cs-137 spectrum: one gamma ray of 0.662 MeV with an 85 percent yield. For the non-removable equipment, the isotope generator is strontium Sr-90 which only emits beta

13 radiation. It emits one negative beta electron, with a maximum energy of 546 keV. Sr-90 is in equilibrium with yttrium (Y-90). The applicant used ORIGEN2.2 to generate the source terms.

The applicants model consists of a minimum number of sources, 14 pins, in every other position, around the outermost ring of the basket only, with the same activity in all positions, and a total activity of 7.4 PBq (200 kCi). The sources are evenly distributed around the outer basket ring as required by the operating instructions. Thus, this configuration minimizes self-absorption in the contents and maximizing the radiation output. Modelling was based on 7.40 PBq contents so the results were scaled up in direct proportion for 8.51 PBq.

The applicant removed non-shielding components (e.g., fasteners, fins, grilles, etc.) from the model as they would have no effect on the results. The applicant only considered gamma radiation. The NRC staff found this approach acceptable because Co-60 produces both gamma and beta radiation, and the interaction of the radiation with the thick shielding of the transport package means that the dose rates will be dominated by gamma radiation rather than the beta.

6.2.3 Summary Tables of Maximum External Radiation Levels Section 9 of the chapter 04-09, Radiation Protection Study, presents the maximum external radiation levels. The B(U) or B(U)F type packaging, comprising a casing and a choice of either an SV34 container, with its EDCI, an SV69 container, or an EDCE, is designed for the transportation of sources, non-removable equipment, and waste.

For NCT, maximum intensities of external radiation obtained for the SV69 configuration, the highest intensity of radiation resulted to be in contact with the package of 7.73x10-2 mSv/h (7.73 mrem/h) with a regulatory limit of 2 mSv/h (200 mrem/h).

For the EDCE configuration (Point source of 1,699 TBq), the maximum intensities of external radiation around the leakage line, against the lateral, internal wall of the SV34, resulted to be 9.81X10-1 mSv/h (98.1 mrem/hr) with a regulatory limit of 2 mSV/h (200 mrem/h).

For the SV34 configuration (Bounding source Co-60 (3700 TBq)), the maximum intensities of external radiation resulted to be in contact to the package (Mid-height radial of the package level with the source) 1.05 x 10-1 mSv/h (10.5 mrem/hr) with a regulatory limit of 2 mSV/h (200 mrem/h).

For ACT, the dose equivalent rates (DER) are determined: at 1 m from the external surface of the package.

For SV34 ACT, maximum intensity of external radiation resulted to be at radial mid-height 3.46E-02 mSV/h (3.46 mrem/h) with a regulatory limit of 10 mSV/h (1,000 mrem/h).

For SV69 ACT, maximum intensity of external radiation resulted to be at Radial mid-height 3.01E-02 mSV/h (3.01 mrem/h) with a regulatory limit of 10 mSV/h (1,000 mrem/h).

For the non-removable equipment (point source of 1,699 TBq of Sr-90), the maximum intensity external radiation resulted to be 9.81E-02 mSV/h (9.81 mrem/h).

The staff reviewed these radiation levels and found them acceptable. The applicant included the maximum radiation levels for this package surfaces and the appropriate distances from the surfaces for this type of transport for which this package is designed and intended.

14 6.3 Shielding Evaluation 6.3.1 Evaluation of Dose Equivalent Rates The applicant determines the DER around a B(U) type packaging equipped with its casing and consisting of an SV34 container with its internal enclosure, an SV69 container or non-removable equipment fitted with an external enclosure, as selected. The irradiation generated by the content of the SV34 and SV69 containers is attributable to a source of Co-60, or a source of Cs-137. According to the results, the source of Co-60 bounds the source of Cs-137.

The applicant used the TRIPOLI 4.3.2 software which uses the Monte-Carlo method to process neutron and gamma transport, as well as neutron-gamma transport (coupled) in 3-D geometries. The Monte-Carlo method deals with physical phenomena (collisions) accurately since it reproduces the life of the particles through the material. TRIPOLI 4.3.2 therefore supplies the averaged results for the events and the associated statistical error (standard deviation). The dose equivalent rates were assessed according to the standard International Commission on Radiological Protection (ICRP) 60,1990 Recommendations of the International Commission on Radiological Protection. The ENDF-B/VI library is used for cross-sections.

Staff evaluated the effects of accident conditions on the package and found reasonable assurance the package meets the requirements of IAEA 2012a. The applicant showed the radioactive material meets the requirements to be determined special source under IAEA 2012a. As a result, staff finds reasonable assurance that any effects on the targets would not result in significant changes from the configuration evaluated by the applicant.

The applicant did not use the flix-to-dose conversion factors in the 1977 revision of American National Standards Institute/American Nuclear Society 6.1.1, which is the NRC acceptable conversion factors. However, the staff found the use of the ICRP 60 acceptable because it is an upgraded version for ICRP 26, which provide the means to derive doses under the dosimetry concept and are appropriate for determining compliance with the limits in 10 CFR 72.104(a) and 10 CFR 72.106(b) limits. Also, the ICRP is used widely throughout the world to limit exposure of both radiation workers and members of the public to ionizing radiations.

6.4 Evaluation Findings

Based on a review of the statements and representations in the MANON package application and as discussed above, the staff has reasonable assurance that the MANON Cask package meets the requirements in paragraphs 523, 526, 527, 648(b), and 659(b)(i) in IAEA SSR-6, 2012 Edition. The staff recommends revalidation of French Competent Authority Certificate F/410/B(U)-96 for the Model No. MANON Cask (MANON Cask).

7.0 MATERIALS EVALUATION The purpose of the materials evaluation is to verify that the materials performance of the MANON package configured for Gisete-4 content meets the regulatory requirements of IAEA SSR-6 (2012). The staffs material review focused on the changes since the staffs most recent recommendation to revalidate the MANON package (2019), including changes to mechanical properties used in the structural analysis, seal specifications, and package inspection requirements. The staff used NUREG-2216, Standard Review Plan for Transportation Packages for Spent Fuel and Radioactive Material, to guide the review of the proposed packaging changes.

15 7.1 Drawings The staff reviewed the drawings and verified that the applicant provided an adequate description of component safety functions, materials of construction, dimensions and tolerances, and fabrication specifications. The staff notes that minor updates to tolerances were incorporated, and drawings were revised to reference newly added procurement specifications for phenolic foam and stainless steels used in the packaging.

Based on the evaluation above, the staff finds that the drawings contain sufficient information to describe the design and manufacture of the package, and the package meets the requirements in paragraph 652 of IAEA SSR-6.

7.2 Materials Codes and Standards The staff reviewed the material codes and standards referenced in the application, many of which come from national (e.g., French Association Française de Normalisation) and international (e.g., International Organization for Standardization [ISO]) standards organizations.

The procurement specifications that were added for the stainless steel plates used for the MANON casing, the EDCE, and the associated shimming systems reference two standards: NF EN 10029 for hot-rolled steel plates and NF EN ISO 9445 for continuously cold-rolled stainless steel. The screws that are used to bolt the casing and EDCE are manufactured in accordance with NF EN ISO 898-1, Mechanical properties of fasteners made of carbon steel and alloy steel.

The staff finds the packages materials codes and standards to be acceptable because they adequately provide materials specifications, mechanical properties, and fabrication requirements and their use conforms to the French construction standards, as applicable. The staff finds that the package meets the requirements in paragraph 652 of IAEA SSR-6.

7.3 Weld Design and Inspection The application provided minor updates to welding specifications, including a statement that all welds are executed in accordance with the updated standard NF EN ISO 15607 (this standard replaces the previously referenced NF P22-470). Additionally, the welding data package and many of the drawings and analyses have been revised to specify radiographic or ultrasonic inspection of the EDCE containment enclosure welds. These radiographic and ultrasonic inspections are performed in accordance with the following standards for non-destructive testing of welds: NF EN ISO 5817, NF EN ISO 10675-1, and NF EN ISO 17460.

Based on the evaluation above, the staff finds that the manufacture of the package is in accordance with applicable standards, and the package meets the requirements in paragraph 659 of IAEA SSR-6.

7.4 Mechanical Properties The application modified the mechanical properties used for the EDCE flange and closure plate screws, as well as the austenitic stainless steel constituting the casing, EDCE, and internal shimming. The yield strength values cited for the screws are consistent with the temperature dependent properties in NF EN ISO 898-1. The increased yield strength values for the EDCE stainless steel were updated in accordance with the stainless steel specification. Additionally, the stainless steel specification provided specific mechanical property values for a small number of external casing components that previously only specified an overall energy density value,

16 due to their puncture-resistance (high strain) function. The specification now has defined values for yield strength, ultimate strength, and elongation (which are used to calculate the energy density), as well as a specified alternative that a steel plate with an inferior mechanical property may be acceptable for these external casing components provided the specified energy density value is met.

The staff determined that these controls for mechanical properties are capable of ensuring that the external casing can perform its puncture resistance function, and therefore finds them to be acceptable. The staff finds that the package meets the requirements in paragraph 652 of IAEA SSR-6.

7.5 Thermal Properties of Materials The applicant did not make any changes that affected the thermal properties of the package materials, and the staff verified that the thermal properties used for the various packaging components (e.g., stainless steel, phenolic foam) remained valid.

Based on the evaluation above, the staff finds that the properties of materials used in the thermal analysis are acceptable, and the package meets the requirements in paragraph 652 of IAEA SSR-6.

7.6 Radiation Shielding Materials As previously analyzed and evaluated, the applicant credited only the stainless steel of the EDCE containment boundary in the radiation shielding analysis in SAR chapter 04-09. The analysis did not model or take credit for the shielding provided by the stainless steel outer casing, phenolic foam impact limiters, or non-removable equipment (i.e. lead biological shielding cask). The staff verified that the shielding analysis identified appropriate material property values for the density and geometry of the EDCE stainless steel.

Based on the evaluation above, the staff finds that the EDCE and meet the requirements in paragraphs 501b and 659 of IAEA SSR-6.

7.7 Corrosion and Chemical Reactions The staff reviewed the design, inspection, and maintenance of the package and confirmed that no changes were made that would affect the physical and chemical compatibility of the packaging and any components or structures. The package design does not include coatings for corrosion protection. The packaging features austenitic stainless steel, which has a high degree of corrosion resistance, and phenolic foam that has substantially low chloride concentration levels. Fusible plugs in the casing and EDCE allow the water in the phenolic foam to vaporize and prevent excessive pressure build-up in the event of a fire. In response to a request for additional information, the applicant clarified that the leak testing for the fusible plugs will consist of a bubble soap test and a pressure gradient test (leak rate 10-3 Pam3s-1) to ensure satisfactory leak-tightness.

Based on the evaluations above, the staff finds that the package design, inspections, and maintenance activities adequately prevent against adverse reactions that may affect the ability of the package to perform its safety functions, and the package meets the requirements in paragraph 652 of IAEA SSR-6.

17 7.8 Bolting Material The application made minor revisions to clarify that the surface treatment of the screws used to bolt the external casing and the EDCE is a dichromate zinc-plated surface treatment to reduce seizing in the stainless steel threads. The staff verified that the bolt materials have adequate tensile strength, resistance to creep and brittle fracture, resistance to corrosion (and other chemical reactions), and a coefficient of thermal expansion compatible with the stainless steel components being bolted together.

The staff finds that the bolting material is appropriate for the application and supports the conclusion that the package is capable of withstanding any effects that may arise during routine conditions of transport (e.g., acceleration, vibration). Based on the evaluation above, the package meets the material requirements in paragraph 652 of IAEA SSR-6.

7.9 Seals The application made minor changes to gasket dimensions and modified the design to replace one of the EPDM elastomer seals used for the EDCE containment boundary with a bi-material gasket consisting of a zinc-plated steel with a nitrile butadiene rubber seal. In response to a request for additional information, the applicant clarified that the new bi-material gasket has no containment or safety function and stated that the purpose of the gasket is to reduce the pressure difference between the internal and external of the EDCE to facilitate opening.

In addition to the design capability of the seals, SAR chapter 05-01 states that a systematic check will be conducted before and after each transport operation to assess the validity and condition of gaskets and mating surfaces, and that all gaskets will be replaced during the minor maintenance period (every 3 years or 30 cycles).

Based on the staffs evaluation of the capability of both the bi-material gasket and EPDM gaskets to perform the applicable functions, in addition to the inspections that will occur to ensure satisfactory performance, the package meets the requirements in paragraph 659 of IAEA SSR-6.

7.10 Evaluation Findings Based on a review of the statements and representations in the application, the staff concludes that the applicant adequately described and evaluated the materials used in the MANON package and that the package (configured for Gisete 4 content) meets the requirements of IAEA SSR-6 (2012).

8.0 QUALITY ASSURANCE EVALUATION The purpose of the quality assurance (QA) [i.e., management system in IAEA SSR-6, 2012 Edition] review is to verify that the packaging incorporates adequate quality controls in its design, manufacture, operation, and maintenance. The staff reviewed the description of the QA program for the Model No. MANON package against the standards in the IAEA SSR-6, 2012 Edition.

8.1 Staffs Evaluation of the Quality Assurance Program The applicant developed and described a QA program for activities associated with transportation packagings for radioactive materials. Those activities include design,

18 procurement, fabrication, assembly, testing, modification, maintenance, repair, and use. The applicant described the QA organizations independence from other branches in the organization, which includes those responsible for product cost and schedule. The applicants description of the QA program meets the requirements of the applicable versions of IAEA SSR-6, International Organization for Standardization, Standard No. 9001, Quality management systems Requirements, and other applicable standards. The staff finds the QA program description acceptable, since it allows implementation of the associated QA program for the design, procurement, fabrication, assembly, testing, modification, maintenance, repair, and use of the Model No. MANON transportation package.

The staff finds, with reasonable assurance, that the QA program for the MANON transportation packaging:

a. meets the requirements in IAEA SSR-6, 2012 Edition, and

b. encompasses design controls, materials and services procurement controls, records and document controls, fabrication and maintenance controls, nonconformance and corrective actions controls, an audit program, and operations or programs controls, as appropriate, adequate to ensure that the package will allow safe transport of the radioactive material authorized in this approval.

8.2 Evaluation Findings

Based on review of the statements and representations in the Model No. MANON package application and as discussed in this SER section, the staff has reasonable assurance that the MANON package meets the requirements in IAEA SSR-6, 2012 Edition. The staff recommends revalidation of French Competent Authority Certificate No. F/410/B(U)-96.

CONCLUSION Based on the statements and representations presented in the SAR and supplemental information, the staff agrees that the package meets the standards in IAEA Safety Standards SSR-6, 2012 Edition but does not provide any calculation to demonstrate that the package meets the tie down system design requirement using acceleration factors in the SSG-26, Table IV.2. The staff recommends that DOT revalidate French Certificate of Approval No.

F/410/B(U)-96, Revision Bi, for import and export use.

Issued with letter to R. Boyle, DOT.