ML21319A050

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E-59637 Letter from Orano to DOT Requesting Review of Japanese Certificate of Compliance
ML21319A050
Person / Time
Site: 07103100
Issue date: 10/11/2021
From: Shaw D
Orano TN Americas
To: Boyle R
Office of Nuclear Material Safety and Safeguards, Radioactive Material Transportation and Storage Consulting, US Dept of Transportation, Pipeline & Hazardous Materials Safety Admin
B WHITE NRC/NMSS/DFM/STLB 3014156577
Shared Package
ML21319A049 List:
References
E-59637
Download: ML21319A050 (98)
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Text

Enclosure 1 to E-59637 Mitsubishi Nuclear Fuel Letter

October 11, 2021 MBB-21-0057 U.S. Department of Transportation Attn: Mr. Richard W. Boyle, Chief Pipeline & Hazardous Materials Safety Administration Radioactive Materials Branch 1200 New Jersey Avenue, S.E.

East Building, PHH-20 Washington, DC 20590

Subject:

Revalidation of Containers required for Fresh Fuel Recovery Projects

Dear Mr. Boyle,

The Japanese nuclear industry is still struggling to recover from impact of the earthquake and tsunami on March 11, 2011. We are slowly but surely resuming various nuclear operations, however, as you may know, it has been decided that the older nuclear power plants which cannot comply with the newly imposed regulatory requirement due to technical or economic reasons, would be decommissioned. Most of these plants had fresh (un-irradiated) fuel in their respective storage areas (both wet and dry) when they were shutdown back in 2011, and as the first critical step in the decommissioning program, the fresh fuel has to be shipped out of the nuclear power plant.

Mitsubishi Nuclear Fuel Co., Ltd., with Framatome Inc. and Orano NPS group (including TN Americas) as essential partners, have contracted with various Japanese utilities to ship this fuel from the Japanese nuclear power plants to Framatomes nuclear fuel fabrication plant in Richland WA to recover the enriched uranium contained within this fuel. We call these projects in a general term, Fresh Fuel Recovery (FFR) project. As for the contaminated fuel which are fuel stored in wet storage, even though the fuel falls under the Type-A package category, considering the surface contamination of the fuel from wet storage and other sources, we intend to use a container which can contain all contamination within the container. This container is called MX-6 (precisely speaking, MX-6 for BWR and MX-6P for PWR) which was originally designed, manufactured and licensed by the Japanese authority (Ministry of Land, Infrastructure and Transportation, back in 2007) as a Type-B package. Due to the earthquake in 2011, the containers were never used and have been stored since then. As the container is capable of transporting Type-B material, it was decided to make use of it and to re-license this container for Type-A material for the FFR projects.

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The FFR projects are extremely important for the Japanese nuclear industry to move forward, and it also is symbolic to show to the public that the plant decommissioning is in progress. We believe that Framatome Inc., an US company, supporting the Japanese decommissioning programs especially the decommissioning of Fukushima Daiichi (1F), is a significant contribution and is in line with the international nuclear cooperation between USA and Japan. We intend to make all possible efforts to successfully ship out the fuel and the revalidation process of the MX-6 containers is a vital bottle neck process to achieve this. The technical evaluation cannot be carried out overnight, but we are committed to support you or anyone in this process so that the shipment schedules of the decommissioning program could be met. The scheduled plan of the FFR projects subjected to use the MX-6 and MX-6P containers are provided in the attachment below for your information.

Your understanding and support on this subject would be highly appreciated. If you have any questions, please do not hesitate to contact me, my staff or any of our partners in the US.

Thank you very much for you attention.

Sincerely, Kenji Umeda President & CEO Mitsubishi Nuclear Fuel, Ltd.

CC: Mr. Ala Alzaben Vice President, Framatome Inc. (ala.alzaben@framatome.com)

Mr. Amir Vexler President, Orano USA and TN Americas (amir.vexler@orano.group)

Mr. Olivier Roulleaux-dugage President and CEO, TN Tokyo (olivier.roulleaux-dugage@orano.group)

Contacts:

Role Company Contacts Overall project lead Mitsubishi Nuclear Fuel Mr. Nori Kaneko norihiko.kaneko.jt@nu.mhi.com (Japan) Phone: +81 90 8646 6538 Fuel recipient Framatome Mr. Kris Mitchell kris.mitchell@framatome.com (U recovery) Phone: +1 509 375 8319 US revalidation TN Americas Ms. Laurence Labbe laurence.labbe@orano.group Phone: +1 410 910 6929 Mr. Peter Vescovi peter.vescovi@orano.group Phone: +1 336 420 8325 Container related TN Tokyo Mr. Nobuhiko Suzuki Suzuki.nobuhiko@tntokyo.com (Japan) Phone: +81 3 3508 2201 2

Attachment:

Summary of Fresh Fuel Recovery Projects (contaminated Fuel) *1 Container Indented schedule Intended schedule of the Utility Site/Unit Number of assembly Type of 1st shipment last shipment MX-6 *2 Tokyo Electric Power Company Fukushima Daiichi (1F) Unit 4 204 Beginning of 2023 2028 Fukushima Daiichi (1F) Unit 6 56 Total of 7 shipments MX-6P *2 Kansai Electric Power Company Mihama Unit 1 36 September 2024 2026 Shikoku Electric Power Company Ikata Unit 1 16 July 2023 *4 Total of 6 shipments Ikata Unit 2 2 *3 Kyushu Electric Power Company Genkai Unit 1 8 September 2025 Genkai Unit 2 16 338 assemblies Total Total of 13 shipments (Approx. 80 tU)

Note 1: Besides the above, there are approx. 240 assemblies (Approx. 100tU) of non-contaminated fuel stored in dry storage, to be shipped to Framatome Inc. using standard fresh fuel containers.

Note 2: MNF has secured 3 MX-6 and 2 MX-6P containers. The 2 MX-6P containers will be commonly used for the PWR fuel respectively for the PWR utilities.

Note 3: As MX-6P can transport 8 PWR fuel, 6 non-contaminated fuel will be transported along with this 2 contaminated fuel.

Note 4: The competent authority at Ehime Prefecture which Ikata is located, uniquely requires completion of all license necessary for transportation (including US revalidation) by end of the year before. Thus, November-December 2022 is the targeted due date to complete the license process for MX-6P.

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Enclosure 2 to E-59637 Competent Authority of Japan Approval Certificate Number J/2037/AF-96, Revision 0 Japanese Original and English Translation

Enclosure 2 to E-59637 Competent Authority of Japan Approval Certificate Number J/2037/AF-96, Revision 0 Japanese Original

Enclosure 2 to E-59637 Competent Authority of Japan Approval Certificate Number J/2037/AF-96, Revision 0 English Translation

Enclosure 3 to E-59637 MX-6P Safety Analysis Report for (Proprietary Version)

Sent as separate enclosure

Enclosure 4 to E-59637 MX-6P Safety Analysis Report for (Public Version)

Sent as separate enclosure

Enclosure 5 to E-59637 Relation between SSR-6 and Japanese regulations

Relation between SSR-6 and Japanese regulations Japanese regulations introduce IAEA regulation basically, however the construction is different and rather complicate. As the result, simple comparison is not easy, and a kind of cross reference table is not prepared officially.

This document includes the following materials.

- Framework of Japanese regulations (You can find the outline by Attachment-1)

- Location of Japanese regulation including a part of SSR-6 requirements

- Chapter II-F of SAR with SSR-6 article numbers Unfortunately, English translation of Japanese regulations are not published, so, just numbers of article etc. are given in the above materials.

We hope this information would be helpful for your understanding.

2021/08/24 Y. Kawano TNT

Framework for Safety Regulation of Transport of Nuclear Fuel Materials in Japan Mode of transport Land transport Sea transport Air transport (Packages / Transport method) (Packages / Transport method)

Packages Transport method Radioactive materials Act on the Regulation of Nuclear Source Ship safety Act (MLIT) Civil Aeronautics Act (MLIT)

Material, Nuclear Fuel Material and Reactors Article 59, Article 64 The Cabinet Order for Enforcement of the Act on the Regulation of Nuclear Source Material, Nuclear fuel materials etc. Nuclear Fuel Material and Reactors Article 48, Article 49 Regulation A NRA Ordinance on Off-Site Transportation MLIT Ordinance on Vehicle Transport of MLIT Regulations for the Carriage and MLIT Ordinance for Enforcement of of Nuclear Fuel Materials, etc. Nuclear Fuel Materials, etc. Storage of Dangerous Goods in Ship the Civil Aeronautics Act Regulation B NRA Notification on Technical Details for MLIT Notification on Details for Vehicle Off-Site Transportation of Nuclear Fuel Transport of Nuclear Fuel Materials, etc.

Materials, etc.

Locations of Japanese regulation including a part of SSR-6 requirements (1/14)

Items in the Ordinance Items in the Notification SSR-6 Other regulation (Regulation A) (Regulation B)

BASIC RADIONUCLIDE VALUES 402 Article 3, Item 1, No.1 Article 3, No. 1, Table No. 1 DETERMINATION OF BASIC RADIONUCLIDE VALUES 403 Article 3, Item 1, No.1 Article 3, No. 1, Table No. 2,3 404 Article 3, Item 1, No.1 Article 3, No. 1, Table No. 6 405 Article 3, Item 1, No.1 Article 3, No. 1, Table No. 5 406 Article 3, Item 1, No.1 Article 3, No. 1, Table No. 2,4,5 407 Article 3, Item 1, No.1 Article 3, No. 1, Table No. 3 CLASSIFICATION OF MATERIAL Low specific activity material 408 409 410 411 Surface contaminated object 412 413 414 Special form radioactive material 415 Low dispersible radioactive material 416 Fissile material 417 418 Uranium hexafluoride 419 420 CLASSIFICATION OF PACKAGES 421 Article 3, Item 1, No.2 Article 3, 4, 5

Locations of Japanese regulation including a part of SSR-6 requirements (2/14)

Items in the Ordinance Items in the Notification SSR-6 Other regulation (Regulation A) (Regulation B)

Classification as excepted package 422 Article 3, Item 1, No.1 Article 3 423 Article 3, Item 1, No.1 Article 3, No. 2 Article 4, Item 1, No.6 424 Article 4, Item 1, No.6 425 Article 28 426 Article 3, Item 1, No.1 Article 3, No. 3 Additional requirements and controls for transport of empty packagings 427 Article 3, Item 1, No.1 Article 3, No. 4 Classification as Type A package 428 429 Article 3, Item 1, No.2 Article 4 430 Classification as Type B(U), Type B(M) or Type C package 431 Article 3, Item 1, No.3 432 433 SPECIAL ARRANGEMENT 434 REQUIREMENTS BEFORE THE FIRST SHIPMENT 501 REQUIREMENTS BEFORE EACH SHIPMENT 502 503 TRANSPORT OF OTHER GOODS 504 Article 3, No.4, 10 505 506

Locations of Japanese regulation including a part of SSR-6 requirements (3/14)

Items in the Ordinance Items in the Notification SSR-6 Other regulation (Regulation A) (Regulation B)

OTHER DANGEROUS PROPERTIES OF CONTENTS 507 REQUIREMENTS AND CONTROLS FOR CONTAMINATION AND FOR LEAKING 508 Article 4, No.8 Article 9 PACKAGES 509 MLIT Ordinance 510 Article 25, 26 511 Article 25, 26 512 MLIT Ordinance 513 Article 26, No.4 514 MLIT Ordinance REQUIREMENTS AND CONTROLS FOR TRANSPORT OF EXCEPTED PACKAGES 515 516 Article 4, No.7 REQUIREMENTS AND CONTROLS FOR TRANSPORT OF LSA MATERIAL AND SCO 517 IN INDUSTRIAL PACKAGES OR UNPACKAGED 518 519 520 Article 13, No.1-I, No.2-I Article 13, No.1- II, No.2- II 521 Article 3, Item 2 Article 6 522 MLIT Ordinance DETERMINATION OF TRANSPORT INDEX 523 Article 17, No.4 Article 36, Item 1 MLIT Ordinance 524 Article 36, Item 1 MLIT Ordinance 524A Article 36, Item 1 MLIT Ordinance

Locations of Japanese regulation including a part of SSR-6 requirements (4/14)

Items in the Ordinance Items in the Notification SSR-6 Other regulation (Regulation A) (Regulation B)

DETERMINATION OF CRITICALITY SAFETY INDEX FOR CONSIGNMENTS, FREIGHT 525 Article 36, Item 2 MLIT Ordinance CONTAINERS AND OVERPACKS LIMITS ON TRANSPORT INDEX, CRITICALITY SAFETY INDEX AND DOSE 526 MLIT Ordinance RATES FOR PACKAGES AND OVERPACKS 527 Article 5, No.7 528 Article 5, No.7 CATEGORIES 529 Article 17, No.7 Article 37, No.1 MARKING, LABELLING AND PLACARDING 530 Marking 531 Article 17, No.7 Article 37, No.2- I MLIT Ordinance 532 533 Article 17, No.7 Article 37, No.2- II MLIT Ordinance 534 Article 17, No.7 Article 37, No.2 MLIT Ordinance 535 536 Article 17, No.7 Article 37, No.3 MLIT Ordinance 536A 537 Labelling 538 539 Labelling for radioactive contents 540 Labelling for criticality safety 541 542

Locations of Japanese regulation including a part of SSR-6 requirements (5/14)

Items in the Ordinance Items in the Notification SSR-6 Other regulation (Regulation A) (Regulation B)

Placarding 543 544 CONSIGNORS RESPONSIBILITIES 545 Particulars of consignment 546 Consignors certification or declaration 547 MLIT Ordinance 548 549 MLIT Ordinance 550 551 552 553 Information for carriers 554 Article 17, No.5- I MLIT Ordinance 555 556 Notification of competent authorities 557 558 559 Article 13 560 Possession of certificates and instructions 561

Locations of Japanese regulation including a part of SSR-6 requirements (6/14)

Items in the Ordinance Items in the Notification SSR-6 Other regulation (Regulation A) (Regulation B)

TRANSPORT AND STORAGE IN TRANSIT Segregation during transport and storage in 562 Article 17, No.3 MLIT Ordinance transit 563 Stowage during transport and storage in 564 Article 17, No.2 MLIT Ordinance transit 565 MLIT Ordinance 566 MLIT Ordinance 567 MLIT Ordinance 568 MLIT Ordinance 569 MLIT Ordinance 570 MLIT Ordinance Additional requirements relating to transport 571 MLIT Ordinance by rail and by road 572 MLIT Ordinance 573 MLIT Ordinance 574 MLIT Ordinance Additional requirements relating to transport 575 MLIT Regulations by vessels (Ship safety Act) 576 MLIT Regulations (Ship safety Act)

Additional requirements relating to transport 577 MLIT Ordinance by air (Civil Aeronautics Act) 578 MLIT Ordinance (Civil Aeronautics Act) 579 MLIT Ordinance (Civil Aeronautics Act)

Locations of Japanese regulation including a part of SSR-6 requirements (7/14)

Items in the Ordinance Items in the Notification SSR-6 Other regulation (Regulation A) (Regulation B)

Additional requirements relating to transport 580 by post 581 CUSTOMS OPERATIONS 582 UNDELIVERABLE CONSIGNMENTS 583 RETENTION AND AVAILABILITY OF 584 TRANSPORT DOCUMENTS BY CARRIERS 585 586 587 REQUIREMENTS FOR RADIOACTIVE MATERIAL Requirements for LSA-III material 601 Requirements for special form radioactive 602 Article 3, No.1 Article 3, No.1 material 603 Article 3, No.1 604 Requirements for low dispersible radioactive 605 material REQUIREMENTS FOR MATERIAL 606 EXCEPTED FROM FISSILE CLASSIFICATION

Locations of Japanese regulation including a part of SSR-6 requirements (8/14)

Items in the Ordinance Items in the Notification SSR-6 Other regulation (Regulation A) (Regulation B)

GENERAL REQUIREMENTS FOR ALL 607 Article 4, No.1 PACKAGINGS AND PACKAGES 608 Article 4, No.1 609 610 Article 4, No.3 611 612 613 Article 4, No.2 613A Article 3, No.3 (for new application) 614 Article 4, No.4 615 Article 4, No.5 616 Article 4, No.2 617 618 MLIT Regulations (Ship safety Act)

ADDITIONAL REQUIREMENTS FOR PACKAGES 619 MLIT Ordinance TRANSPORTED BY AIR (Civil Aeronautics Act) 620 MLIT Ordinance (Civil Aeronautics Act) 621 MLIT Ordinance (Civil Aeronautics Act)

REQUIREMENTS FOR EXCEPTED PACKAGES 622 Article 4 REQUIREMENTS FOR INDUSTRIAL PACKAGES 623 Article 8 624 Article 9, Item 1 Article 21, Annex 9

Locations of Japanese regulation including a part of SSR-6 requirements (9/14)

Items in the Ordinance Items in the Notification SSR-6 Other regulation (Regulation A) (Regulation B)

Requirements for Type IP-3 625 Article 10, Item 1 Article 22, Annex 10 Alternative requirements for Type IP-2 and Type IP-3 626 Article 9, Item 2 627 Article 9, Item 2 Article 10, Item 2 628 Article 9, Item 2 Article 10, Item 2 629 Article 9, Item 2 Article 10, Item 2 630 Article 9, Item 2 Article 10, Item 2 REQUIREMENTS FOR PACKAGES CONTAINING URANIUM HEXAFLUORIDE 631 632 Article 12 Article 28 633 Article 12, Item 2, No.4 634 Article 12 REQUIREMENTS FOR TYPE A PACKAGES 635 Article 5 Article 4 636 Article 5, No. 2 637 Article 5, No. 3 638 MLIT Regulations (Ship safety Act) 639 Article 5, No. 4 640 MLIT Regulations (Ship safety Act) 641 MLIT Regulations (Ship safety Act) 642 MLIT Regulations (Ship safety Act) 643 MLIT Regulations (Ship safety Act) 644 MLIT Regulations (Ship safety Act)

Locations of Japanese regulation including a part of SSR-6 requirements (10/14)

Items in the Ordinance Items in the Notification SSR-6 Other regulation (Regulation A) (Regulation B)

REQUIREMENTS FOR TYPE A PACKAGES 645 (cont.) Article 5, No. 5 646 Article 5, No. 1 (Article 4, No. 5) 647 MLIT Regulations (Ship safety Act) 648 Article 5, No. 9 Article 13, Annex 3 649 Article 5, No. 6- II 650 Article 5, No. 9 Annex 3, No. 2 Article 5, No. 6- I 651 Article 5, No. 10 Annex 3, No. 2 REQUIREMENTS FOR TYPE B(U) PACKAGES 652 Article 7, No. 1 653 Article 7, No. 2 Article 19, Annex 7 654 Article 7, No. 2 655 Article 7, No. 2 (Article 6, No. 2- III) 656 Article 7, No. 2 Article 19, Annex 7 (Annex 4) 657 Article 7, No. 2 Article 19, Annex 7 658 Article 7, No. 3 Article 20, Annex 8 (Annex 5) 659 Article 7, No. 2 Article 19, Annex 7 Article 7, No. 3 Article 20, Annex 8 (Annex 5)

Article 17 660 Article 7, No. 1 Article 18, Annex 6 (Article 6, No. 5) 661 Article 7, No. 5 662 MLIT Regulations (Ship safety Act) 663 664 Article 7, No. 6

Locations of Japanese regulation including a part of SSR-6 requirements (11/14)

Items in the Ordinance Items in the Notification SSR-6 Other regulation (Regulation A) (Regulation B)

REQUIREMENTS FOR TYPE B(U) PACKAGES 665 (cont.)

666 Article 7, No. 4 REQUIREMENTS FOR TYPE B(M) 667 MLIT Regulations PACKAGES (Ship safety Act) 668 REQUIREMENTS FOR TYPE C PACKAGES 669 670 671 672 REQUIREMENTS FOR PACKAGES 673 Article 11 CONTAINING FISSILE MATERIAL 674 Article 23, Item 2, No. 1- III (1),

(2), (3)

Article 23, Item 2, No. 1- I 675 Article 23, Item 2, No. 2 Contents specification for assessments of 676 package designs containing fissile material 677 Article 25, No. 2 Geometry and temperature requirements 678 Article 11, No. 1 Article 24, Annex 11 679 Article 11, No. 3 Assessment of an individual package in 680 Article 11, No. 2- I, II, III Article 25, No. 1 isolation 681 Article 25, No. 3 682 Article 11, No. 2- I, II, III Article 25 683

Locations of Japanese regulation including a part of SSR-6 requirements (12/14)

Items in the Ordinance Items in the Notification SSR-6 (Regulation A) (Regulation B) Other regulation Assessment of package arrays under normal 684 Article 11, No. 2- IV Article 27 conditions of transport Annex 11 Assessment of package arrays under accident 685 Article 11, No. 2- V Article 27 conditions of transport Article 26, Annex 12 Determination of criticality safety index for 686 packages DEMONSTRATION OF COMPLIANCE 701 702 LEACHING TEST FOR LOW DISPERSIBLE 703 Article 3, Item 2 Article 5, No. 3- III, Annex 2 RADIOACTIVE MATERIAL TESTS FOR SPECIAL FORM RADIOACTIVE MATERIAL General 704 Article 2, No. 1, Annex 1 Test methods 705 Annex 1, No. 1 706 Annex 1, No. 2 707 Annex 1, No. 3 708 Annex 1, No. 4 709 Article 3, No. 1 Article 3, No. 1 Leaching and volumetric leakage assessment 710 Article 3, No. 1, Annex 1, No. 5-I methods 711 Article 3, No. 1 TESTS FOR LOW DISPERSIBLE 712 RADIOACTIVE MATERIAL

Locations of Japanese regulation including a part of SSR-6 requirements (13/14)

Items in the Ordinance Items in the Notification SSR-6 Other regulation (Regulation A) (Regulation B)

TESTS FOR PACKAGES Preparation of a specimen for testing 713 714 715 716 Target for drop tests 717 Test for packagings designed to contain 718 Article 12, Item 2, 3 Article 29, Annex 13 uranium hexafluoride Article 32, Annex 16 Tests for demonstrating ability to withstand 719 Article 13, Annex 3, No. 1 normal conditions of transport 720 721 Article 13, Annex 3, No. 1-I 722 Article 13, Annex 3, No. 1-II (1),

(2) 723 Article 13, Annex 3, No. 1-II (3) 724 Article 13, Annex 3, No. 1-II (4)

Additional tests for Type A packages designed 725 Article 13, Annex 3, No. 2 for liquids and gases Tests for demonstrating ability to withstand accident 726 Article 6, No. 3 Article 16, Annex 5 conditions of transport Article 6, No. 5 Article 18, Annex 6 727 Article 16, Annex 5, No. 1-I, II 728 Article 16, Annex 5, No. 2 729 Article 16, Annex 5, No. 3

Locations of Japanese regulation including a part of SSR-6 requirements (14/14)

Items in the Ordinance Items in the Notification SSR-6 Other regulation (Regulation A) (Regulation B)

Enhanced water immersion test for Type B(U) 730 Article 18, Annex 6 and Type B(M) packages containing more than 105A2 and Type C packages Water leakage test for packages containing 731 Article 26, Annex 12, No. 1-IV fissile material 732 Article 26, Annex 12, No. 1-II, III 733 Article 26, Annex 12, No. 1-IV Tests for Type C packages 734 735 736 737

II - F Evaluation of compliance to the Ordinance and the Notification This package is type A package. The evaluation of the compliance to the Ordinance and the Notification for this package is shown in Table II -F.1.

II - F - 1

Table II-F.1 Evaluation of compliance with the technical standards of the Ordinance and the Notification (1/13)

Items in the Ordinance Items in the Notification Corresponding Explanation (Regulation A) (Regulation B) items in SSR-6 (Transport of nuclear materials as (Nuclear materials can be nuclear fuel package) transported as Type L package)

Article 3 Item 1 No.1 Article 3 422 Not applicable (Limit of activity of nuclear materials which can be transported as Type A package)

No.2 Article 4 429 The nuclear fuel material contained in this packaging falls under the category called Others than special type nuclear fuel materials etc. It is un-irradiated uranium with maximum enrichment of 5 % and maximum radioactive quantity of 590 GBq. Thus, the uranium falls under the U (un-irradiated uranium with II - F - 2 enrichment not more than 20%) in Table No.1 of the Notification and A2 value unlimited.

On the other hand, the radioactive quantity adhered on the contents is sufficiently smaller than A2 value even if the influence of storage in a spent fuel pool is considered.

Thus, the radioactivity contained in this packaging does not exceed the A2 value, and this packaging is categorized as the type A packaging.

No.3 431 Not applicable Item 2 408, 412, 521 Not applicable Item 3 (Section VI) This package conforms to the technical standards specified by Articles 4 to 10 as described below:

Table II-F.1 Evaluation of compliance with the technical standards of the Ordinance and the Notification (2/13)

Items in the Ordinance Items in the Notification Corresponding Explanation (Regulation A) (Regulation B) items in SSR-6 (Technical standards for Type L packages)

Article 4 This package is designed so that handling operation is capable easily by using No. 1 607, 608 trunnions or handling belts on body and a dedicated lifting device with crane.

Assuming that the maximum weight of the package is applied with a handling load with a safety factor of 3 particularly during abrupt lifting, the strength of the packaging body, trunnions and handling belts was evaluated by calculation using a formula based on mechanics of materials as well as the ABAQUS code.

The evaluation has shown that the package has a sufficient strength to accommodate the handling load and can be thus handled safely.

No. 2 616 As shown in the followings, this packaging is designed so that there is no possibility of cracks, breakage, etc. due to changes of ambient temperature II - F - 3 (40 to 38) and pressure and vibration, etc. expected to occur during transportation as shown below.

1. The minimum temperature of the package components and contents is 40C, which is the expected minimum ambient temperature during transportation. The maximum temperature of the packaging components and contents is 70C according to an evaluation conservatively conducted with considerations given to the heat supply from solar insolation specified in the normal conditions of transport for Type BM packages, although this is a Type A package.

616 2. The dimensional changes of the package due to thermal expansion within the expected temperature range from 40C to 70C during transportation were evaluated using a physical formulation. The evaluation has shown that the packaging body will never interfere with the basket. It has also shown that there is a sufficient clearance between the contents, i.e., fuel assemblies, and the packaging body or lodgments and they will never interfere with each other. In addition to the evaluation, another evaluation using the ABAQUS code was also conducted to determine the thermal stress of the packaging body, indicating that the packaging body has a sufficient strength against the thermal stress expected to occur.

Table II-F.1 Evaluation of compliance with the technical standards of the Ordinance and the Notification (3/13)

Items in the Ordinance Items in the Notification Corresponding Explanation (Regulation A) (Regulation B) items in SSR-6 These evaluation results indicate that the packaging will not be damaged by the expected temperature changes during transportation, maintaining the structural integrity of this packaging.

616 3. As the packaging is exposed to temperature changes during transportation, its internal pressure may be 0.186 MPa absolute at maximum or 0.065 MPa absolute at minimum. Based on a conservative assumption that the pressure difference between the internal pressure and the ambient pressure is 0.202 MPa (inside pressure) or 0.101 MPa (outside pressure) in case the ambient pressure decreases to 60 kPa, strength evaluation was conducted using the ABAQUS code. The evaluation has shown that the containment system of the packaging has a sufficient strength to maintain the structural integrity of the packaging. It has also shown that the displacement of opening in the lid gasket part is sufficiently smaller than the gasket compression by initial tightening (compressed thickness), maintaining the containment performance.

II - F - 4 613 4. This package is transported with its shell part secured to the transport frame.

Assuming that the expected acceleration during transportation is 2 G in the direction of travel, 3 G in the vertical direction and 2 G in the lateral direction, strength evaluation was carried out using the ABAQUS code. The evaluation has shown that the shell part of the packaging secured to the transport frame has a sufficient strength to maintain the structural integrity of the packaging.

613 5. The natural frequency of the package determined through the use of the ABAQUS code is not less than 55 Hz. This implies that no resonance will be caused by the expected vibration during transportation (mainly 20 Hz or less).

The package may also be applied with load amplification due to vibration during transportation when taking into account the maximum response factor of 1.2 against transportation vibration. Still, according to the evaluation stated in item 4 above, the shell part of the packaging body has an adequate strength with a sufficient safety allowance against the assumed acceleration even if it is applied with the amplified load. Thus, the structural integrity will not be lost.

In terms of the lid, lid fixing bolts and bottom, a formula based on mechanics of materials was used to evaluate their strength, which has proven that they have a sufficient strength. Therefore, the packaging maintains its structural integrity even with the possible load amplification due to vibration.

Table II-F.1 Evaluation of compliance with the technical standards of the Ordinance and the Notification (4/13)

Items in the Ordinance Items in the Notification Corresponding Explanation (Regulation A) (Regulation B) items in SSR-6 No. 3 610 On the surface of this package, no protrusion exists except the trunnions, handling belts and lifting lug of shock absorbing covers to be used for handling.

And, the surface of this package is finished smoothly and removing contaminations can be performed easily when it is contaminated with radioactive material.

No. 4 614 The packaging components use chemically stable materials such as stainless steel and titanium alloy. No hazardous physical or chemical reaction could occur between any combinations of the materials constituting the packaging or between the materials constituting the packaging and the contents.

1. As indicated in Article 4 No.2, any thermal expansion of the materials constituting the packaging and the contents within the expected temperature range during transportation can never cause a crack or rupture due to interference (constraint) between the materials or between the materials and II - F - 5 the contents.
2. As this package is dry type without coolant, there is no possibility of breakage of package due to freezing.
3. The resin (vinyl-ester resin) and gaskets (EPDM) never chemically react with metal when they come into contact with metal.
4. The resin is hermetically sealed in the shell part, lid, and bottom of the packaging body. Since the package is used in dry condition, the components will have no corrosion between their materials.

No. 5 615 The quick connection installed in the lid has a quick connection cover. It is also designed to be protected by the top shock absorbing cover during transportation.

Therefore, no undue operation is possible during transportation.

No. 6 424 (b) Not applicable No. 7 516 Not applicable

Table II-F.1 Evaluation of compliance with the technical standards of the Ordinance and the Notification (5/13)

Items in the Ordinance Items in the Notification Corresponding Explanation (Regulation A) (Regulation B) items in SSR-6 (External contamination limit)

No. 8 Article 9 508 The external contamination of this package is checked to confirm that it does not exceed the criteria at the inspection before shipment.

No. 9 622 (636) Not applicable No. 10 504 As the contents inspection is carried out as an inspection before shipment when fuels are loaded to confirm that there is nothing to be loaded other than specified things such as the fuel assembly, the stool and the packing materials etc., it is not possible that something, which could impair the safety of this package, are loaded.

(Technical standards for Type A packages)

Article 5 II - F - 6 No. 1 635 This package conforms to the standards specified by the previous article (Articles

4) Item 1 to 5 and 8 and 10 as mentioned above.

No. 2 636 This package is cylindrical container with outside dimensions having external diameter of approx. 2.1 m and total length of approx. 6.0 m, then each side of the circumscribed rectangular solid is more than 10 cm.

No. 3 637 The lid of this package is securely installed by the lid tightening bolts, and as the lid is covered with the top shock absorbing cover on which security seal is installed during transportation, no undue operation is possible, and it is clearly indicated that it has been opened if that is the case.

No. 4 638 Since the expected ambient temperature range for this package during transportation is from 40C to 38C as indicated in Article 4 No.2, the packaging components are assumed to have a temperature from 40C to 70C. Within this temperature range, the packaging components will not experience significant embrittlement or strength decrease of materials, so this temperature range will not affect their required strength of materials. Therefore, the components will not have a crack or breakage within the temperature range from 40C to 70C

Table II-F.1 Evaluation of compliance with the technical standards of the Ordinance and the Notification (6/13)

Items in the Ordinance Items in the Notification Corresponding Explanation (Regulation A) (Regulation B) items in SSR-6 No. 5 645 Even if the ambient pressure is assumed to be 60 kPa as indicated in Article 4 No.2, the packaging maintains its structural integrity and the displacement of opening in the lid gasket part is sufficiently smaller than the gasket compression by initial tightening (compressed thickness). This means that the containment system of this packaging is maintained, and no leakage of radioactive material is possible.

No. 6 649, 650 (b) Not applicable (Equivalent dose rate)

No. 7 Article 8 527, 528 This package was analyzed using the DORT code under the following conservative conditions. The analysis has shown that the maximum equivalent dose rate on the surface of the package under routine conditions of transport is not more than 6 Sv/h and never exceeds the criterion of 2 mSv/h.

II - F - 7

1. In terms of the uranium source intensity of the contents, the maximum radioactivity should be used with considerations given to decay of the uranium isotope nuclides.
2. The fuel assemblies as the contents of the package include those that were stored in the spent fuel pool. Therefore, the fuel assemblies should be considered as a radioactive source on an assumption that part of the radioactive materials included in the pool water remains on the surface of the fuel assemblies.
3. In the analysis model, all the basket parts except the lodgments and aluminum spacers should be ignored. The parts of the basket located below the lodgments should be replaced by the air. The shock absorbing covers should be conservatively replaced with the air, but only the distance should be considered.

No. 8 Article 8 (573) According to the results of an analysis conducted under the same conditions as those Different criteria specified by Article 5 No.7, the maximum equivalent dose rate in a position 1 m away from the surface of the package under routine conditions of transport is not more than 2 Sv/h and never exceeds the criterion of 100 Sv/h.

Table II-F.1 Evaluation of compliance with the technical standards of the Ordinance and the Notification (7/13)

Items in the Ordinance Items in the Notification Corresponding Explanation (Regulation A) (Regulation B) items in SSR-6 (Normal conditions of transport for Type A packages and additional conditions of transport for Type A packages containing liquid or gaseous nuclear fuel materials)

No. 9 Article 13 Annex 3 No.1 721 a. Water spray The packaging, whose external surface is made of bare or painted stainless steel, never has deterioration or corrosion due to water absorption during water spray test. Therefore, this test will never affect the structural integrity or containment performance of the package. And also, the packaging will have no damage that would affect the shielding analysis.

722 b. Free drop This package should be subjected to a free drop test from a height of 0.3 m since its maximum weight is 19.5 ton. Free drop events from this height were II - F - 8 analyzed using the LS-DYNA code to determine the stress and strain that can occur in various parts of the package.

The packaging body was evaluated for the vertical, horizontal and corner drop positions in such a way that can maximize the damage. For the purpose of analysis, the maximum weight of the package was conservatively assumed to hit a rigid surface. The analysis has shown that a minute plastic strain of maximum 0.5 % occurs in the packaging body, but the stress of the lid fixing bolts and containment sealing surface is below the yield stress. No opening that would cause leakage in the lid gasket part occurs. The shock absorbing covers have deformation of maximum 77 mm.

The basket was evaluated for the horizontal drop in which the basket is applied with the total weight of the contents to have maximum damage. The evaluation has shown that no plastic strain occurs in the basket components.

The fuel assemblies as the contents were evaluated for the vertical and horizontal drops in which the compressive and bending loads applied to the fuel cladding are both highest.

The evaluation has shown that the fuel cladding will not rupture.

According to these results, the package shows the following condition after being subjected to this test:

  • The packaging maintains its structural integrity and containment performance in spite of a minute plastic strain of the packaging body.
  • The shock absorbing covers are slightly deformed.

Table II-F.1 Evaluation of compliance with the technical standards of the Ordinance and the Notification (8/13)

Items in the Ordinance Items in the Notification Corresponding Explanation (Regulation A) (Regulation B) items in SSR-6

  • The basket maintains its structural integrity.
  • The fuel cladding has no rupture and the fuel assemblies maintain their containment.

723 c. Stacking test For this package, the load equivalent to five times the gross weight of the package is higher than the projected area of the packaging multiplied by 13 kPa.

Therefore, the stacking test was conducted by applying a load equivalent to five times the package weight (19.5 ton).

The shell part was evaluated using the ABAQUS code, which has shown that the stress that occurs in the shell part is below the design yield stress. The shock absorbing covers were evaluated using a formula based on mechanics of materials, which has revealed that the shock absorbing covers have no significant deformation.

In terms of the lid gasket part, the load applied to the packaging during the stacking test is smaller than the load applied during the free drop test and is II - F - 9 embraced by the free drop test results. No opening that would cause leakage in the lid gasket part will occur.

Therefore, the packaging never loses its structural integrity or containment performance during this test. And the packaging also has no damage that would affect the shielding analysis when it is subjected to this test.

724 d. Penetration The package was subjected to a penetration test in which a bar of a mass of 6 kg and a diameter of 3.2 cm is dropped from a height of 1 m on to the outer surface of the package, in order to evaluate the penetration.

Among the outer surfaces of the packaging body constituting the containment system, the external plate has the smallest thickness. The drop of the bar onto the external plate was evaluated using a formula based on mechanics of materials.

The evaluation has shown that the dropped bar will not penetrate the external plate and will not reach the containment boundary. Furthermore, among the outer surfaces of the package including the parts other than the containment system, the outer plate of the shock absorbing covers has the smallest thickness.

The drop of the bar on to this outer plate was evaluated using the LS-DYNA code. The evaluation has shown that the dropped bar will not penetrate the outer plate of the shock absorbing covers and will not reach the containment system protected by the shock absorbing covers.

Table II-F.1 Evaluation of compliance with the technical standards of the Ordinance and the Notification (9/13)

Items in the Ordinance Items in the Notification Corresponding Explanation (Regulation A) (Regulation B) items in SSR-6 Therefore, the packaging will never lose its structural integrity or containment performance during this test. And the packaging also will have no damage that would affect the shielding analysis when it is subjected to this test.

Annex 3 No.2 725 Not applicable No. 9 I 648 (a) As mentioned above, when this package is placed under normal conditions of transport, the package will never lose the containment performance and its containment will be maintained. Therefore, no leakage of radioactive material occurs.

No. 9 II 648 (b) As mentioned above, when this package is placed under normal conditions of transport, the shock absorbing covers will be slightly deformed, but the packaging body will maintain its structural integrity. The containment of the II - F - 10 packaging and fuel assemblies will also be maintained.

Based on the evaluation approach stated in Article 5 No.7, the equivalent dose rate was evaluated using the DORT code with considerations given to the deformation of the shock absorbing covers. The results show that the maximum equivalent dose rate on the surface is not more than 6 Sv/h, showing no increase from the level under routine conditions of transport. It can be concluded that the maximum equivalent dose rate on the surface will never exceed the criterion of 2 mSv/h with no substantial increase No. 10 651 Not applicable Article 6 667 Not applicable Article 7 652 Not applicable Article 8 623 Not applicable Article 9 624 Not applicable Article 10 625 Not applicable

Table II-F.1 Evaluation of compliance with the technical standards of the Ordinance and the Notification (10/13)

Items in the Ordinance Items in the Notification Corresponding Explanation (Regulation A) (Regulation B) items in SSR-6 (Technical standards of nuclear (Normal conditions of transport for material package for fissile materials) package containing fissile materials)

Article 11 Article 24 Annex 11 678 Under normal conditions of transport for packages containing fissile material, this package shows the same condition as that described in Article 5 No.9 (normal conditions of transport for Type A packages).

(Accident conditions of transport for package containing fissile materials)

Article 26 Annex 12 732 a. Drop test I Free drop events from a height of 9 m were analyzed using the LS-DYNA code to determine the stress and strain that can occur in various parts of the package.

The packaging body was evaluated for the vertical, horizontal, corner and slap down drop positions in such a way that can maximize the damage. For the II - F - 11 purpose of analysis, the maximum weight package was conservatively assumed to hit a rigid surface during a drop test from a height of 9.3 m with considerations given to accumulated damages attributable to the 9.0 m drop as well as the 0.3 m drop. The analysis has shown that a local plastic strain occurs in the packaging body, but it is smaller than the elongation. The shock absorbing covers have deformation of maximum 310 mm.

The basket was evaluated for the horizontal drop in which the basket is applied with the whole of weight of the contents to have maximum damage. The evaluation has shown that a local plastic strain occurs in the basket components, but it is smaller than the elongation.

The fuel assemblies as the contents were evaluated for the vertical and horizontal drops in which the compressive and bending loads applied to the fuel cladding are both highest. The evaluation has shown that the fuel cladding will not rupture.

According to these results, the package shows the following condition after being subjected to this test:

  • The shock absorbing covers are deformed.
  • The packaging body and basket maintain their shape only with a local plastic strain.

Table II-F.1 Evaluation of compliance with the technical standards of the Ordinance and the Notification (11/13)

Items in the Ordinance Items in the Notification Corresponding Explanation (Regulation A) (Regulation B) items in SSR-6 732 b. Drop test II The damage of the packaging after being dropped from a height of 1 m on to a mild steel bar of a diameter of 15 cm was evaluated by a drop test using a 1/2 scale model. This drop test has revealed the following. When the packaging is vertically dropped so that the lid or bottom is directly hit, the shock absorbing covers rupture and part of the inner shell swells toward inside but will not rupture. The containment performance of the packaging is maintained.

Effect of the swelling of the inner shell after the horizontal drop to directly hit the shell part stated above to the basket was evaluated using the LS-DYNA code. The evaluation has shown that the structural sections in the vicinity of the directly hit parts are deformed and the aluminum plates have a local plastic strain exceeding the elongation, but the lodgments loading fuel assemblies maintain their arrangement. No deformation that would damage the fuel II - F - 12 assemblies will occur.

732 c. Thermal test (fire resistance test)

The damaged condition of this package after being subjected to fire resistance test was evaluated using the ABAQUS code and different formulas to determine the temperature, stress and strain of the package components.

The initial temperature for the fire resistance test, i.e., the ambient temperature of 38C superimposed by the solar insolation, was calculated using a formula based on heat transfer engineering. The result was 70C. Then, the thermal analysis using the ABAQUS code was conducted to evaluate the temperature of the packaging during the fire resistance test. In addition, the internal pressure of the packaging was calculated by formulas of pressure and temperature then a structural evaluation of the packaging using the ABAQUS code and another structural evaluation of the fuel cladding using a formula based on mechanics of materials were conducted.

Table II-F.1 Evaluation of compliance with the technical standards of the Ordinance and the Notification (12/13)

Items in the Ordinance Items in the Notification Corresponding Explanation (Regulation A) (Regulation B) items in SSR-6 The thermal analysis model for the fire resistance test was developed with considerations given to the possibility of reduction of heat transfer distance due to the deformation of the shock absorbing covers during the drop test I. The evaluation temperature of the fuel assemblies as the contents was conservatively set to the maximum temperature of the basket.

According to these results, the package shows the following condition after being subjected to this test.

  • The inner shell is deformed in such a manner that the central part swells to have a larger inner radius by 4.8 mm.
  • Part of the resin and of the wood inside the shock absorbing covers are carbonized.

II - F - 13 731, 733 d. Immersion test (0.9 m)

This is not applicable since leakage of water was already assumed in the criticality evaluation.

For the 15 m immersion test, the ABAQUS code was used to carry out analysis.

The results show that the packaging will not have significant deformation.

Therefore, for the Notification Annex 12, the conditions specified in No.1 are the conditions under which the packaging can have the maximum damage.

Article 11 673 The package has been verified through analysis not to reach criticality under the Body text conditions including the during transport conditions. The package also conforms to each item of the Regulation as follows:

No. 1 I 678 When this package is under these conditions, the shock absorbing covers are deformed, but structural parts of the packaging body have no dent that can embrace a cube measuring 10 cm per side.

II 678 This package is a cylindrical container with outside dimensions having an external diameter of approx. 2.1 m and a total length of approx. 6.0 m.

Even if the shock absorbing covers are deformed when this package is under these conditions, each side of the circumscribed rectangular solid is not less than 10 cm.

Table II-F.1 Evaluation of compliance with the technical standards of the Ordinance and the Notification (13/13)

Items in the Ordinance Items in the Notification Corresponding Explanation (Regulation A) (Regulation B) items in SSR-6 Article 11 (Normal conditions of transport for Based on the damaged condition of this package under normal and accident No. 2 package containing fissile materials) conditions of transport for packages containing fissile materials, the following I, II, III, IV, V Article 24 682 (b) conservative conditions were established. An analysis model with an infinite number of packages embracing all the conditions including the during transport conditions (Accident conditions of transport for specified in the main text of Article 11 as well as the conditions A to E of No.2 of package containing fissile materials) Article 11 was developed and subjected to analysis using the SCALE code system Article 26 682 (c) (KENO-VI code):

1. With the damaged condition of the packaging taken into account, all the parts (Condition of individual package outside the inner shell of the packaging body as well as the lid, bottom and shock in isolation for package containing absorbing covers are ignored, and a packaging model with an infinite number of fissile materials) packages arranged in a given layout in which the longitudinal length is assumed to Article 25 680, 681 be infinite has been established by setting total reflection boundary condition outside the model.

II - F - 14 (Condition of package arrays for 2. With the possibility of deformation of the fuel assemblies taken into account, the package containing fissile materials) fuel assemblies are arranged in the lodgments with expansion of fuel rod pitch for Article 27 684, 685 all spans.

3. On an assumption that water enters the package, the water density inside/outside the packaging is optimized to maximize the effective multiplication factor.

These analyses have revealed that the effective multiplication factor is 0.91655 and the package never reaches criticality.

No. 3 679 The components of this packaging will have no crack or breakage due to changes in ambient temperature within the range from 40C to 70C.

As this package is dry type without coolant, there is no possibility of breakage of package due to freezing.

IRRS Follow-up Mission to JAPAN 2020 SARIS Summary Report (Safety Requirements for Transport of Radioactive Material)

November 2019 Ministry of Internal Affairs and Communication Ministry of Health, Labour and Welfare Nuclear Regulation Authority Japan

IRRS Follow-up Mission to JAPAN 2020 Contents 1 Framework for safety regulation of transport of radioactive materials in Japan ...................................... 3 2 Authorization ................................................................................................................................... 4 2.1 Authorization in land transport of nuclear fuel materials etc. .................................................................. 4 2.1.1 Conclusions ..................................................................................................................................... 4 2.1.2 Generic issues .................................................................................................................................. 5 2.1.3 Authorization requirements for transport ............................................................................................. 5 2.1.4 Improvement of the competence of the staff of Nuclear Regulation Authority related to transport of nuclear fuel materials etc. .............................................................................................................................. 6 2.1.5 Action Plan ...................................................................................................................................... 6 2.2 Authorization in land transport of nuclear source materials .................................................................... 6 2.2.1 Conclusions ..................................................................................................................................... 6 2.2.2 Generic issues .................................................................................................................................. 6 2.3 Authorization in land transport of radioisotopes etc. .............................................................................. 7 2.3.1 Conclusions ..................................................................................................................................... 7 2.3.2 Generic issues .................................................................................................................................. 7 2.3.3 Authorization requirements for transport ............................................................................................. 7 2.3.4 Improvement of the competence of the staff of Nuclear Regulation Authority related to transport of radioisotopes etc................................................................................................................................ 8 2.4 Authorization in land transport of radiopharmaceuticals ........................................................................ 8 2.4.1 Conclusions ..................................................................................................................................... 8 2.4.2 Generic issues .................................................................................................................................. 8 2.5 Authorization in land transport by post etc. .......................................................................................... 8 2.5.1 Conclusions ..................................................................................................................................... 8 2.5.2 Generic issues .................................................................................................................................. 8 3 Review and assessment ..................................................................................................................... 9 3.1 Review and assessment in land transport of nuclear fuel materials etc. .................................................... 9 3.1.1 Conclusions ..................................................................................................................................... 9 3.1.2 Generic issues .................................................................................................................................. 9 3.2 Review and assessment in land transport of radioisotopes etc. ............................................................... 10 3.2.1 Conclusions ................................................................................................................................... 10 3.2.2 Generic issues ................................................................................................................................ 10 3.3 Review and assessment in land transport of radiopharmaceuticals ......................................................... 11 3.3.1 Conclusions ................................................................................................................................... 11 3.3.2 Generic issues ................................................................................................................................ 12 3.4 Review and assessment in land transport by post etc. ........................................................................... 12 3.4.1 Conclusions ................................................................................................................................... 12 3.4.2 Generic issues ................................................................................................................................ 12 4 Inspection ...................................................................................................................................... 12 4.1 Inspection in land transport of nuclear fuel materials etc. ................................................................... 12 4.1.1 Conclusions ................................................................................................................................... 12 4.1.2 Generic issues ................................................................................................................................ 12 4.2 Inspection in land transport of nuclear source materials ....................................................................... 13 4.2.1 Conclusions ................................................................................................................................... 13 4.2.2 Generic issues ................................................................................................................................ 13 4.3 Inspection in land transport of radioisotopes etc. ................................................................................. 13 4.3.1 Conclusions ................................................................................................................................... 13 4.3.2 Generic issues ................................................................................................................................ 13 4.4 Inspection in land transport of radiopharmaceuticals ........................................................................... 14 4.4.1 Conclusions ................................................................................................................................... 14 4.4.2 Generic issues ................................................................................................................................ 14 4.5 Inspection in land transport by post etc. ............................................................................................. 14 4.5.1 Conclusions ................................................................................................................................... 14 4.5.2 Generic issues ................................................................................................................................ 14 5 Enforcement .................................................................................................................................. 14 1

IRRS Follow-up Mission to JAPAN 2020 5.1 Enforcement in land transport of nuclear source materials and nuclear fuel materials etc. ......................... 14 5.1.1 Conclusions ................................................................................................................................... 14 5.1.2 Generic issues ................................................................................................................................ 15 5.2 Enforcement in land transport of radioisotopes etc. .............................................................................. 15 5.2.1 Conclusions ................................................................................................................................... 15 5.2.2 Generic issues ................................................................................................................................ 15 5.3 Enforcement in land transport of radiopharmaceuticals ....................................................................... 16 5.3.1 Conclusions ................................................................................................................................... 16 5.3.2 Generic issues ................................................................................................................................ 16 5.4 Enforcement in transport by post etc. ................................................................................................ 16 5.4.1 Conclusions ................................................................................................................................... 16 5.4.2 Generic issues ................................................................................................................................ 17 6 Regulations and guides .................................................................................................................... 17 6.1 Regulations and guides in land transport of nuclear source materials and nuclear fuel materials etc............ 17 6.1.1 Conclusions ................................................................................................................................... 17 6.1.2 Generic issues ................................................................................................................................ 17 6.1.3 Action plan .................................................................................................................................... 19 6.2 Regulations and guides in land transport of radioisotopes etc. ............................................................... 20 6.2.1 Conclusions ................................................................................................................................... 20 6.2.2 Generic issues ................................................................................................................................ 20 6.3 Regulations and guides in land transport of radiopharmaceuticals.......................................................... 20 6.3.1 Conclusions ................................................................................................................................... 20 6.3.2 Generic issues ................................................................................................................................ 20 6.4 Regulations and guides in transport by post etc................................................................................... 21 6.4.1 Conclusions ................................................................................................................................... 21 6.4.2 Generic issues ................................................................................................................................ 21 7 Emergency response ....................................................................................................................... 21 7.1 Emergency response in land transport of radioactive materials .............................................................. 21 7.1.1 Conclusions ................................................................................................................................... 21 7.1.2 Generic issues ................................................................................................................................ 21 7.1.3 Action Plan .................................................................................................................................... 22 8 Radiation protection ........................................................................................................................ 24 8.1 Radiation protection in land transport of nuclear source materials and nuclear fuel materials etc................ 24 8.1.1 Conclusions ................................................................................................................................... 24 8.1.2 Generic issues ................................................................................................................................ 24 8.2 Radiation protection in land transport of radioisotopes etc. ................................................................... 24 8.2.1 Conclusions ................................................................................................................................... 24 8.2.2 Generic issues ................................................................................................................................ 24 8.3 Radiation protection in land transport of radiopharmaceuticals........................................................... 25 8.3.1 Conclusions ................................................................................................................................... 25 8.3.2 Generic issues ................................................................................................................................ 25 8.4 Radiation protection in transport by post etc. ...................................................................................... 25 8.4.1 Conclusions ................................................................................................................................... 25 8.4.2 Generic issues ................................................................................................................................ 25 2

IRRS Follow-up Mission to JAPAN 2020 1 Framework for safety regulation of transport of radioactive materials in Japan There are several responsible authorities for the regulation for safe transport of radioactive materials in Japan, according to the type of materials to be transported (nuclear fuel material, nuclear source materials, radioisotopes and radiopharmaceuticals) and mode of transport (land, sea, air and post), they are appropriately developed according to the requirements for authorization on safety regulations specified in IAEA Regulations for the Safe Transport of Radioactive Material (SSR-6) without overlapping and thus basically comply with IAEA safety standards on transport, except for the issues described later.

The responsibilities of the related ministries are as follows. (see Figure 1.)

Regarding the safety regulations related to land transportation of nuclear fuel materials, based on the Act on the Regulation of Nuclear Source Material, Nuclear Fuel Material and Reactors (hereinafter referred to as the Reactor Regulation Act.), Nuclear Regulation Authority (NRA) is responsible for the regulations on packages. Additionally, Ministry of Land Infrastructure, Transport and Tourism (MLIT) is responsible for the safety regulations on the transport methods.

Based on the Reactor Regulation Act, NRA is responsible for packages and transport method related to the safety regulations of land transportation of nuclear source materials.

Regarding the safety regulations related to land transport of radioisotopes, based on the Act on the Regulations on Radioisotopes etc. (hereinafter referred to as the RI Act.), NRA is responsible for the regulations of packages.

Additionally, MILT is responsible for the regulations on the transport methods.

Ministry of Health Labour and Welfare (MHLW) is responsible for the safety regulations for radiopharmaceuticals, both for packages and transport methods, based on the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (hereinafter referred to as the Pharmaceuticals and Medical Devices Act.).

Ministry of Internal Affairs and Communication (MIC) is responsible for the safety regulations for transport of radioactive materials by post etc., based on the Postal Act and the Act on Correspondence Delivery by Private Business Operators (hereinafter referred to as the Postal Act etc.).

Furthermore, MLIT is responsible for the safety regulations for sea transport and air transport of radioactive materials both for packages and transport methods, based on the Ship Safety Act and the Civil Aeronautics Act, respectively. Additionally, the National Police Agency and the Japan Coast Guard are responsible for the date and route of transportation to secure safety.

For the purpose of liaison and coordination among related regulatory authorities responsible for safety regulations for transport of radioactive materials, Interagency Coordination Meeting for the Safe Transport of Radioactive Material are regularly held (2 to 4 times a year), where the opinions are exchanged regarding information exchange and issues related to establishment and amendment of IAEA regulations for the safe transport of radioactive material, the matters related to domestic laws and regulations based on the said regulations and the matters related to safety measures for transport.

Please note that the scope of the review related to transport of radioactive materials in the IRRS follow-up mission, will include only following part of land transportation among all the transport modes: the part related to regulations on land transport of nuclear fuel materials and nuclear source materials and radioisotopes that NRA is responsible for (regarding nuclear fuel materials and radioisotopes, limited to the regulations related to packages), the part related the regulations on land transport of radiopharmaceuticals that MHLW is responsible for, and the part related to the regulations on transport of radioactive materials by post etc. that MIC is responsible for, and the part that requires liaison with the relevant bodies such as emergency response (interface related part only).

3

IRRS Follow-up Mission to JAPAN 2020 Mode of Land Transport Sea Air Transport Packages Transport Method Transport Transport (packages/tra (packages/tr Radioactive nsport ansport method method Materials Nuclear Fuel Reactor Regulation Reactor Regulation Materials etc. Act Act NRA Ordinance on Off-Site MLIT Ordinance on Transportation of Nuclear Vehicle Transport of Fuel materials, etc. Nuclear Fuel Materials, (NRA) etc.

(MLIT) Ship Safety Civil Radioisotopes RI Act RI Act Act Aeronautics NRA Ordinance for MLIT Ordinance on Act Enforcement of the Act on Vehicle Transport of (MLIT) (MLIT) the regulation of Radioisotopes Radioisotopes, etc. (MLIT)

(NRA)

Radiopharmaceuticals Pharmaceuticals and Medical Devices Act (MHLW)

Land transport of nuclear source materials are regulated by the Reactor Regulation Act. (NRA)

Transport by post etc. is regulated by the Postal Act in addition to the above-mentioned Act.

(MIC)

The National Police Agency and the Japan Coast Guard: the date and route of transportation to secure safety.

Fire and Disaster Management Agency: response to fire/accidents etc.

Figure 1. Framework for Safety Regulation of Transport of Radioactive Materials in Japan 2 Authorization 2.1 Authorization in land transport of nuclear fuel materials etc.

2.1.1 Conclusions Based on the self-assessment (SARIS) for the requirements for authorization of land transport of nuclear fuel materials or the materials contaminated by nuclear fuel materials (hereinafter referred to as nuclear fuel materials etc..), it finds that the Reactor Regulation Act provide the legal framework for authorizations appropriately. The requirements, formats and contents of applications for approval, and criteria for the review are well developed, tailored for each authorization stage, based on a graded approach according to radiation risk. Therefore, it identified that the framework and measures for authorizations are in principle in accordance with relevant IAEA safety requirements, except in the following circumstances:

Maintaining consistency and compliance in the management of authorization related to transport of radioactive materials is important. Therefore, NRA should consider to improve the competence of the staff in cooperation with the staff of other regulatory authorities concerned through job training.

To address these challenges, NRA will implement improvement measures based on the Acton Plan as shown in 2.1.5.

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IRRS Follow-up Mission to JAPAN 2020 2.1.2 Generic issues For transport of nuclear fuel materials, pursuant to Article 59(1) of the Reactor Regulation Act, a nuclear operator (including a person to which shipment has been entrusted from a nuclear operator, etc.

The same shall apply hereinafter) shall take the necessary safety measures in compliance with the technical standards specified in the NRA regulations.

Additionally, when necessary for prevention of disasters (in the case of transporting fuel package, fissile package, Type B (U) package or Type B (M) package outside the sites that contain 0.1 kg or more of uranium hexafluoride that requires design approval of package in SSR-6), a nuclear operator shall obtain the confirmation of NRA before shipment in accordance with Article 59(2) of the Reactor Regulation Act. NRA shall require the nuclear operator to submit documents to explain safety of packages upon application for authorization to NRA, pursuant to Article 19 of the NRA Ordinance on Off-Site Transportation of Nuclear Fuel Material etc. (hereinafter referred to as the Nuclear Off-Site Transportation Ordinance), NRA has the authority to determine the said authorization of confirmation of the packages related to land transport of nuclear fuel materials etc.

2.1.3 Authorization requirements for transport A nuclear operator shall be required to obtain package confirmation by NRA before shipment when necessary for prevention of disasters as described in 2.1.2, pursuant to Article 59(2) of the Reactor Regulation Act. The nuclear operator can gradually obtain package design approval and packaging approval prior to package confirmation. In the case where the nuclear operator obtain those approvals, the said nuclear operator shall be able to omit submission of the documents etc. for applications for packaging approval and package confirmation respectively. NRA shall examine compliance with the technical standards specified in the Nuclear Off-Site Transportation Ordinance in each stage of package design approval, packaging approval and package confirmation, based on the applications from nuclear operators according to the type of the nuclear fuel package.

For package design approval, NRA shall examine safety of package design, quality management system of nuclear operators related to design/manufacturing/maintenance/handling of package including the training of the staff, maintenance/handling method of packages. In the case where the design of the package is approved as complying with the technical standard, NRA shall issue the certificate for package design containing nuclear fuel material.

For packaging approval, in addition to the examination matters of package design approval, NRA shall examines the specifications of nuclear fuel materials to be contained, manufacturing method of packaging (including the quality management system related to manufacturing method of packaging),

that the said packaging complies with the design and manufacturing method and the said package is maintained and manufactured and maintained in compliance with design and manufacturing method.

In the case where the packaging is approved as complying with the technical standard, NRA shall issue the certificate for packaging approval with individually identified register number for approved packaging. Additionally, NRA shall manage the register number for approved packaging.

For package confirmation, in addition to the examination matters of packaging approval (possible to be omitted in the case of having obtained package design approval), NRA shall examine the specifications of nuclear fuel materials to be transported and inspection prior to shipment of package.

In the case where the package is approved as complying with the technical standard, NRA shall issue transport confirmation certificate.

Furthermore, in the case where it is extremely difficult to transport the package in accordance with the transport regulations of the Reactor Regulation Act, NRA shall examines the measures and reasons that are difficult to be taken and take necessary measures pursuant to Article 14 of the Nuclear Off-Site Transportation Ordinance. In the said examination, in the case where NRA recognized that necessary measures are taken to secure safe transport and there is no obstacle to secure safety, it shall issue the certificates related to specific measures (limited to the part related to package).

Additionally, as a part of amendment and establishment of relevant regulations/guides associated with enforcement of new inspection system (scheduled to enact in April of 2020), NRA will requires the nuclear operators that will conduct land transport of nuclear fuel materials etc. to develop the method and the organization related to the implementation of quality management related to transport of nuclear fuel materials and preserve the records.

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IRRS Follow-up Mission to JAPAN 2020 2.1.4 Improvement of the competence of the staff of Nuclear Regulation Authority related to transport of nuclear fuel materials etc.

For improvement of the competence of the staff of regulatory body related to transport of nuclear fuel materials etc., as well as the staff of related to commercial nuclear reactor facilities, in addition to the ability evaluation as a part of personnel evaluation for the staff, Nuclear Regulation Authority establishes the basic policy for human resource development and specifies the qualifications to the positions that require highly professional expertise and experience. Then it evaluates the competence of individual staff by conducting oral examination corresponding to each qualification for appointment to the staff engaged in the duties as safety examiners and assigned appropriate qualification for appointment. Subsequently, it has been improved continuously by implementing various kinds of training programs including OJT.

As mentioned above, there are several responsible authorities for the authorization of transport of radioactive materials, maintaining consistency and compliance in the management of authorization related to transport of radioactive materials is important. Therefore, NRA will implement improvement measures based on the Action Plan as shown in 2.1.5 in cooperation with the relevant regulatory authorities, considering adoption of the latest Edition of IAEA Regulations for the Safe Transport of Radioactive Material (2018 Edition) into domestic regulations.

2.1.5 Action Plan No. 1 Basis (B1) IAEA safety standard states the building of competence shall be required for all parties with responsibilities for the safety of facilities and activities, (including authorized parties, the regulatory body and organizations providing services or expert advice on matters relating to safety.) GSR Part1 (Rev.1) R11, para 2.35..

Recommendation (R1) Maintaining consistency and compliance in the management of authorization related to transport of radioactive materials is important. Therefore, NRA should consider to improve the competence of the staff in cooperation with the staff of relevant regulatory authorities by utilizing the training programs.

Action Plan (A1) Maintaining consistency and compliance in the management of authorization related to transport of radioactive materials is important. Therefore, NRA will consider to improve the competence of the staff in cooperation with the staff of relevant regulatory authorities by providing the training programs.

2.2 Authorization in land transport of nuclear source materials 2.2.1 Conclusions Based on the self-assessment (SARIS) for the requirements for authorization of land transport of nuclear source materials, it finds that the Reactor Regulation Act provide the legal framework for authorizations appropriately based on a graded approach according to radiation risk. Therefore, in principle, it identified that the requirements such as the standards for authorization are in accordance with relevant IAEA safety requirements.

2.2.2 Generic issues For transport of nuclear source materials, in compliance with the Reactor Regulation Act, a licensed user of nuclear source materials shall conduct shipment in compliance with the technical standards based on Graded approach according to radiation risk specified by the regulatory authority (the NRA Ordinance on Use of Nuclear Source Materials, Article 2(xii)).

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IRRS Follow-up Mission to JAPAN 2020 2.3 Authorization in land transport of radioisotopes etc.

2.3.1 Conclusions Based on the self-assessment (SARIS) for the requirements for authorization of land transport of radioisotopes or the materials contaminated by radioisotopes (hereinafter referred to as radioisotopes etc..), it finds that the RI Act provide the legal framework for authorizations appropriately. The requirements, formats and contents of applications, and criteria for the review are well developed, tailored for each authorization stage, based on a graded approach according to radiation risk. Therefore, it identified that the framework and measures for authorizations are in principle in accordance with relevant IAEA safety requirements, except in the following circumstances:

It is important that NRA has consistency and compliance in the management of authorization related to transport of radioactive materials. Therefore, it is necessary to improve the competence of the staff in cooperation with the staff of other regulatory authorities concerned through training.

To address these challenges, NRA will implement improvement measures based on the Acton Plan as shown in 2.1.5.

2.3.2 Generic issues For transport of radioisotopes etc., pursuant to Article 18(1) of the RI Act, permission or notification uses etc. shall take the necessary safety measures to prevent radiation hazards in compliance with the technical standards specified in the NRA regulations.

Additionally, pursuant to Article 18(2) of the RI Act, when necessary for prevention of radiation hazards (in the case of transporting Type B (U) package or Type B (M) package outside the sites that requires design approval of package in SSR-6), permission or notification users shall obtain the confirmation of NRA before shipment by the administration. NRA shall require the applicants to submit documents to explain safety of packages upon application for authorization to NRA, pursuant to the NRA Ordinance for Enforcement of the Act on Regulation of Radioisotopes, etc. (hereinafter referred to as the RI Ordinance). In the case of confirmation of the package related to land transport of radioisotopes etc., the certification for transport confirmation related to package shall be issued. Before transport confirmation, the applicants can obtain packaging approval and can also obtain the package design approval. In addition, in the framework, special arrangement regarding transport of radioisotopes etc., can also be approved.

2.3.3 Authorization requirements for transport Permission or notification users etc. are required to obtain confirmation by the administration (package confirmation) for Type B (U) package or Type B (M) package that the RI Act specifies as specially necessary to prevent radiation hazards before transport, based on Article 18(2) of the RI Act.

Prior to package confirmation, regarding compliance with the technical standard of packaging used for transport, permission or notification users etc. can obtain approval from NRA (packaging approval) can gradually obtain package design approval and packaging approval prior to package confirmation, based on Article 18(3) of the RI Act. When it conducts packaging approval, NRA shall issue the certificate for packaging by assigning a series of individually identified register number for approved packaging. Additionally, NRA shall manage the register number for approved packaging.

Furthermore, prior to packaging approval, regarding the design of packaging partly contained in packaging approval, based on Article 18-17(4) of the RI Ordinance, the permission or notification users etc. can obtain the approval (package design approval) from NRA in advance, regarding compliance with the technical standard.

Moreover, based on Article 18-12 of the RI Ordinance, pursuant to the technical standard for various radioactive package, the permission or notification users can transport the packaging in the case where it is extremely difficult to transport the package in accordance with the technical standards specified in Article 18-3 of the NRA Ordinance for Enforcement of the Act on regulation of Radioisotopes, etc. and 7

IRRS Follow-up Mission to JAPAN 2020 in the case where NRA recognizes that necessary measures are taken to secure safe transport and there is no obstacle to secure safety even if the said users transport the packaging not pursuant to the regulations of radioactive package.

2.3.4 Improvement of the competence of the staff of Nuclear Regulation Authority related to transport of radioisotopes etc.

For improvement of the competence of the staff of regulatory body related to transport of radioisotopes etc., in addition to of the ability evaluation as a part of personnel evaluation for the staff, NRA establishes the basic policy for human resource development and specifies the qualifications to the positions that require highly professional expertise and experience. Then it evaluates the competence of individual staff by conducting oral examination corresponding to each qualification for appointment to the staff engaged in the duties as safety examiners and assigned appropriate qualification for appointment. Subsequently, it has been improved continuously by implementing various kinds of training programs including OJT.

There are several responsible authorities for the authorization of transport of radioisotopes etc.,

maintaining consistency and compliance in the management of authorization related to transport of radioactive materials. Therefore, as well as for transport of nuclear fuel materials etc., NRA will implement improvement measures based on the Action Plan as shown in 2.1.5 in cooperation with the relevant regulatory authorities.

2.4 Authorization in land transport of radiopharmaceuticals 2.4.1 Conclusions Regarding authorization on transport of radiopharmaceuticals, pursuant to Ministerial Ordinance/Notification based on the provisions of Pharmaceuticals and Medical Devices Act, similarly as the RI Act, MHLW performs necessary regulations appropriately by specifying rules/standard to incorporate IAEA safety standards.

2.4.2 Generic issues Including the cases to handle radiopharmaceuticals, under the Pharmaceuticals and Medical Devices Act, manufacturers of pharmaceuticals, marketing authorization holders, wholesale distributors and pharmacy proprietors are respectively required to obtain prescribed License. Where and to the extent land transport of radiopharmaceuticals is performed pursuant to the Ministerial Ordinance/Notification based on the provisions of Pharmaceuticals and Medical Devices Act, neither approval nor certificate is required related to the said transport. However, in the case where it is extremely difficult to transport pursuant to the said rule/standard, specific measures can be taken to provide approval for land transport that does not comply with the said rule/standard assuming that there is no obstacle for safety.

2.5 Authorization in land transport by post etc.

2.5.1 Conclusions Regarding transport by post etc., pursuant to the Ministerial Ordinance/Notification based on the Postal Act etc., MIC performs necessary regulations appropriately by specifying rules/standards regarding handling of radioactive materials etc., in compliance with IAEA safety standard. Additionally, under the Postal Act etc., handling of nuclear fuel materials that require authorizations etc. specified in IAEA safety standard is prohibited. It is specified that the transport of radioactive materials is acceptable only if radiation of the said radioactive materials does not exceed 1/10 of Type L package and satisfies specific conditions.

2.5.2 Generic issues At present, under the Postal Act etc., while only Japan Post Co., Ltd. can prove post services, there 8

IRRS Follow-up Mission to JAPAN 2020 is a license system for correspondence delivery. Under the Postal Act etc., handling of radioactive materials etc. by post etc. is in principle prohibited. However, the transport of radioactive materials is acceptable only if radiation of the said radioactive materials does not exceed 1/10 of Type L package and satisfies specific conditions. In such case, neither approval nor certificate is required related to the transport of the said radioactive materials.

3 Review and assessment 3.1 Review and assessment in land transport of nuclear fuel materials etc.

3.1.1 Conclusions Based on the self-assessment (SARIS) for review and assessment related to transport of nuclear fuel materials etc., it finds that the relevant laws and regulations provide the legal framework requiring licensees to conduct safety assessment, and NRA conducts its review and assessment on the licensees applications before authorization. This legal framework (law, regulation, instruction) is well developed with consideration of a graded approach according to radiation risk. Therefore, it identifies that the framework and measures for review and assessment are in principle systematically in accordance with the relevant IAEA safety requirements, except in the following circumstance as described in 6.

Regulations and guides.

3.1.2 Generic issues Article 59(2) of the Reactor Regulation Act requires the submission of applications and necessary appendixes that explain the safety and other measures for transport for nuclear fuel materials etc. subject to the conformation by NRA that the conditions for regulatory requirements and authorizations are satisfied.

NRA develops and publishes its ordinances, standards and guides, similar to the examinations for commercial reactor facilities. These define the items to be reviewed to verify application compliance to the relevant requirements, so that applicants understand the required application information in advance. In conducting a review, if NRA identifies unclear explanations in any submitted documents, it requires applicants to provide supplementary information to ensure the accuracy and sufficiency of the information for review and assessment.

Information to be provided upon applications Package design approval Explanatory documents on safety of nuclear fuel package (i) Explanation for nuclear fuel packages and safety analysis of nuclear fuel packages (ii) Basic policy for quality management related to design, manufacturing, handling and maintenance etc. of nuclear fuel packages in general (iii) Maintenance of packaging and handling method of nuclear fuel packages Packaging Approval Explanatory documents on nuclear fuel materials etc. to be transported Explanatory documents on safety of package of nuclear fuel materials (possible to be omitted in the case of having obtained package design approval)

Explanatory documents on manufacturing method of packaging (including explanation on inspection method of packaging, explanation on quality management of manufacturing)

Explanatory documents that prove that packaging is manufactured according to the method for design and manufacturing (including the results of packaging inspection, the results of quality auditing related to manufacturing of packaging)

Explanatory documents that proves that packaging is maintained in compliance with the design and the method for manufacturing (maintenance records of packaging after completion of packaging until the application of packaging approval) 9

IRRS Follow-up Mission to JAPAN 2020 Package confirmation Explanatory documents on nuclear fuel materials etc. to be transported Explanatory documents on safety of nuclear fuel package (possible to be omitted in the case of having obtained packaging approval)

Explanatory documents on manufacturing method of packaging (including explanation related to the method of inspection of packaging and explanation related to quality management related to manufacturing, possible to be omitted in the case of having obtained packaging approval)

Explanatory documents that proves that packaging is manufactured in compliance with the design and the method for manufacturing (including the results of packaging inspection, the results of quality audits related to manufacturing of packaging, possible to be omitted in the case of having obtained packaging approval)

Explanatory documents that proves that packaging is maintained in compliance with the design and the method for manufacturing (maintenance records of packaging after completion of packaging until the application of package confirmation; however, possible to be partly omitted in the case of having obtained packaging approval)

Explanatory documents on the inspection of nuclear materials prior to shipment Additionally, a certificate is issued for package design approval and packaging approval, which has a period of five years in principle. It may also be renewed when confirmed that there is no modification in design and the packaging is properly maintained and controlled.

3.2 Review and assessment in land transport of radioisotopes etc.

3.2.1 Conclusions Based on the self-assessment (SARIS) for review and assessment related to transport of radioisotopes etc. specified in IAEA safety standard, it finds that the RI Act provide the legal framework requiring licensees to conduct safety assessment for each authorization stage of regulated facilities and activities, and under which NRA conducts its review and assessment on the users applications before authorization. This legal framework (law, regulation, instruction) is well developed with consideration of a graded approach according to radiation risk etc. Therefore, it identifies that the framework and measures for review and assessment are in principle systematically in accordance with the relevant IAEA safety requirements, except in the following circumstance as described in 6. Regulations and guides.

3.2.2 Generic issues For transport of radioisotopes etc., pursuant to Article 18(1) of the RI Act, permission or notification uses etc. shall take the necessary safety measures to prevent radiation hazards in compliance with the technical standards.

Pursuant to Article 18(2) of the RI Act, in the case where it is identified that the measures for the transport of Type B (U) package or Type B (M) package that requires design approval of package required by the administration in order to prevent radiation hazards complies with the technical standard by the applications of packaging confirmation by permission or notification users, by the confirmation of the application and its appendix regarding the following matters or the confirmation of actual delivery place of packaging, NRA shall issue a certificate for packaging confirmation.

Explanatory documents regarding radioisotopes etc. to be transported Explanatory documents regarding the structure, materials and manufacturing method of packaging that packages the said radioisotopes and safety of radioisotopes etc. in the case where the said radioisotopes are packaged in the said packaging Explanatory documents that prove that the packaging is manufactured according to the design of the packaging Explanatory documents that prove that packaging is maintained in compliance with the design 10

IRRS Follow-up Mission to JAPAN 2020 of the packaging Explanatory documents on the inspection of package containing the radioactive materials prior to shipment Prior to the above-mentioned packaging confirmation, based on Article 18(3) of the RI Act, permission or notification users etc. can obtain packaging approval regarding compliance with the technical standard of the packaging used for transport. In the case where the compliance of the packaging with technical standard is approved by permission or notification users submission of the applications and appendix explanatory documents for the packaging approval application by the users based on the RI Act, NRA shall issue a certificate for packaging confirmation.

Explanatory documents regarding radioisotopes etc. scheduled to be transported by packaging Explanatory documents regarding packaging design and radioisotopes etc.in the case where radioisotopes etc. are packaged in the said packaging Explanatory documents that prove that the packaging is manufactured according to the design of the packaging Explanatory documents that prove that packaging is maintained in compliance with the design of In addition, based on Article 18-17 of the RI Act, regarding compliance with the technical standard regarding the package design as a part of packaging approval, packaging design approval can be obtained in advance. NRA shall issue the certificate for package design containing nuclear fuel material upon conducting package design approval.

Upon examination of packaging approval conducted prior to package confirmation, NRA independently evaluates and verifies safety analysis documents and their relevant examination data and technical data for technical standard specified by the RI Act and the RI Ordinance etc. On the occasion, NRA may require the ground of analysis and additional analysis. Furthermore, it is identified that the packaging is manufactured according to the design based on the results of inspections such as material inspections and welding inspections etc.

Additionally, NRA requires the users etc., in compliance with Examination Guideline for Quality Management related to Manufacturing of Packaging of Nuclear Fuel Materials to establish and implement quality management system related to packaging.

NRA shall require the users etc. to take necessary measures to prevent radiation hazards pursuant to technical standard based on the RI Act, regarding transport of radioisotopes etc.

For the valid period related to packaging approval, the period of usage in the application of packaging approval shall be described. While there is no legal standard, the said period shall be described in the certificate of packaging approval with consideration of service life of the packaging itself. In addition, upon renewal of the period of package approval, the renewal of the period for use can be approved by proving that the said packaging is maintained in compliance with the design of packaging.

Also, regarding the application for renewal of package design approval, the valid period can be renewed as specified in Article 25 of Notification that specifies the details etc. related to the technical standard regarding transport outside the Sites of Radioisotopes etc. that specifies the details etc. related to the technical standard pursuant to the RI Act regarding transport outside the Sites of Radioisotopes etc. as well, by proving that there is no modification in design.

Regarding transport of radioisotopes etc., the users etc. shall be required to take necessary measures to prevent radiation hazards in accordance with the technical standard based on the RI Act. In the case of transport of Type B (U) package and Type B (M) package, the users etc. shall obtain packaging confirmation by the administration on each occasion. In such cases, NRA confirms the valid period described on the certificate of packaging approval as well.

3.3 Review and assessment in land transport of radiopharmaceuticals 3.3.1 Conclusions Regarding review and assessment on land transport of radiopharmaceuticals, pursuant to Ministerial Ordinance/Notification based on the provision of the Pharmaceuticals and Medical Devices Act, 11

IRRS Follow-up Mission to JAPAN 2020 similarly as the RI Act, MHLW performs necessary regulations appropriately by specifying rules/standards to incorporate IAEA safety standard. As long as land transport of radiopharmaceuticals is performed according to the said rules/standard, review and assessment in advance related to the said transport shall not be required.

3.3.2 Generic issues Regarding review and assessment on land transport of radiopharmaceuticals, pursuant to the Ministerial Ordinance/Notification based on the provision of the Pharmaceuticals and Medical Devices Act, MHLW performs necessary regulations appropriately by specifying rules/standard to incorporate IAEA safety standard. As long as land transport of radiopharmaceuticals is performed according to the said rules/standards, review and assessment in advance related to the said transport shall not be required.

3.4 Review and assessment in land transport by post etc.

3.4.1 Conclusions Under the Postal Act etc., handling of nuclear fuel materials that require authorizations etc. specified in IAEA safety standard is prohibited, which is identified as compliance with IAEA safety standard.

3.4.2 Generic issues At present, under the Postal Act etc., while only Japan Post Co., Ltd. can prove post services, there is a license system for correspondence delivery. Under the Postal Act etc., handling of radioactive materials etc. by post etc. is in principle prohibited. However, the transport of radioactive materials is acceptable (limited to the case where radiation of the said radioactive materials does not exceed 1/10 of Type L package and satisfies specific conditions) pursuant to Ministerial Ordinance/Notification based on the Postal Act. In such case, neither approval nor certificate is required related to the transport of the said radioactive materials.

4 Inspection 4.1 Inspection in land transport of nuclear fuel materials etc.

4.1.1 Conclusions Based on the self-assessment (SARIS) for the inspection related to transport of nuclear fuel materials etc., similarly to the inspection system for commercial reactor facilities, it finds that the Reactor Regulation Act provide the legal framework for the inspection related to transport of nuclear fuel materials etc. appropriately. The framework to confirm the licensees appropriate response to the regulatory requirements related to transport of nuclear fuel materials etc. is well developed by on-site inspection in confirmation system of transport related to package. Therefore, it identified that the framework is in principle in accordance with relevant IAEA safety requirements.

4.1.2 Generic issues In the inspection for transport of nuclear fuel materials etc., pursuant to the Reactor Regulation Act, based on graded approach according to radiation risk, application for package confirmation of Type B package, NRA shall confirm propriety of the inspection contents by attending the pre-shipment inspection conducted by the nuclear operators, if necessary. Additionally, in the inspection based on application for packaging approval or package design approval, as the prior procedure of package confirmation, regarding the compliance of the contents of the said application with the technical standard, NRA normally confirm by the documents submitted. However, based on graded approach, the staff of NRA may directly confirm the compliance with the technical standard by entering into the sites of the nuclear operators etc. or the manufacturers that manufacture the packaging.

12

IRRS Follow-up Mission to JAPAN 2020 Further, due to enforcement of amended Reactor Regulation Act (scheduled to enact in April of 2020),

various inspections that had been conducted by NRA will be integrated to Nuclear Regulation Inspection, allowing NRA to monitor/evaluate the implementation status of the measures to be taken by the licensees pursuant to law by setting the inspection samples according to the risk without limit to the timing and objects. Pursuant to Article 68(2) and Article 61-2-2 of amended Act, NRA will have authority to enter and confirm the sites such as the plants of the licensees, manufacturers and the persons concerned that conduct transport of nuclear fuel materials etc. as the nuclear regulation inspections as required for enforcement of the amended Act. Thus, necessary ordinance/guides shall be developed by the said enforcement (scheduled to enact in April of 2020).

4.2 Inspection in land transport of nuclear source materials 4.2.1 Conclusions Based on the self-assessment (SARIS) for the inspection related to transport of nuclear source materials, it finds that the Reactor Regulation Act provides the legal framework to confirm that the permission users of nuclear source materials appropriately respond to regulatory requirements related to transport of nuclear source materials by on-site inspections for the permission users of nuclear source materials. Therefore, it identified that the framework is in principle in accordance with relevant IAEA safety requirements.

4.2.2 Generic issues Article 57-7(6) of the Reactor Regulation Act specifies that the type, volume, handling method of the nuclear source materials transported, and the measures at the occurrence of accidents and other matters to be noticed should be maintained as records regarding the said transport in the case where the permission users of nuclear source materials conduct transport of nuclear source materials. Pursuant to Article 68 of the Reactor Regulation Act, NRA has the authority to conduct on-site inspections for the permission users of nuclear source materials and confirm the records related to transport. Additionally, NRA will conduct follow-ups for incompliance found in on-site inspections.

4.3 Inspection in land transport of radioisotopes etc.

4.3.1 Conclusions Based on the self-assessment (SARIS) for the inspection related to transport of radioisotopes etc., it finds that the RI Act provides the legal framework to confirm that the permission users of radioisotopes etc. appropriately respond to regulatory requirements related to transport of radioisotopes etc. by on-site inspections for the permission users of radioisotopes etc. Therefore, it identified that the framework is in principle in accordance with relevant IAEA safety requirements.

4.3.2 Generic issues It is specified that the measures required for transport of radioisotopes etc. should be taken to prevent radiation hazards pursuant to Article 18 of the RI Act. Among these, in the case of transport of Type B (U) package and Type B (M) package outside the Sites etc., it is required to obtain packaging confirmation by the administration. In package confirmation, NRA confirms the matters regarding radioisotopes etc. that the packaging is maintained in compliance with the packaging design and the matters related to the inspection prior to shipping of radioactive package, in addition to the contents approved in the packaging approval.

NRA has the authority to conduct on-site inspections for the permission users of pursuant to Article 43-2(1) of the RI Act, and to enter the office of the users etc. or the Sites to the extent necessary for enforcement of the RI Act and inspect the account books etc. In the case where the users etc. transport all types of radioisotopes etc., the said users shall describe the date, methods and the shippers or the names of shippers or receivers or titles regarding transport to the account books and are required to keep them for five years.

13

IRRS Follow-up Mission to JAPAN 2020 Additionally, pursuant to Article 42 of the RI Act, NRA can collect report for the users etc. In the case where NRA requires the users etc. to report the status of transport of all the transport of radioisotopes etc. conducted outside the Sites, the users etc. shall be required to report the said status within the period.

4.4 Inspection in land transport of radiopharmaceuticals 4.4.1 Conclusions Regarding land transport of radiopharmaceuticals, pursuant to the Pharmaceuticals and Medical Devices Act, similarly as the RI Act, MHLW conducts confirmations and inspections required as a regulatory authority in order to incorporate IAEA safety standard.

4.4.2 Generic issues Regarding land transport of radiopharmaceuticals, MHLW specifies the rules/standards in order to incorporate IAEA safety standard pursuant to the Ministerial Ordinance/Notification based on the provisions of the Pharmaceuticals and Medical Devices Act and conducts regular confirmation upon the renewal of the said permission for the Licensees including whether land transport of radiopharmaceuticals is performed in compliance with the said rules/standards. Furthermore, pursuant to the Pharmaceuticals and Medical Devices Act, MHLW can conduct Inspection by entering into the site to handle radiopharmaceuticals for operation when it deems necessary as the regulatory authority.

4.5 Inspection in land transport by post etc.

4.5.1 Conclusions Regarding transport by post etc., pursuant to Act on Japan Post Co., Ltd. etc., to the extent necessary for enforcement of the act, the regulatory authority can require the report and can conduct on-site inspections. The framework to be well developed to confirm appropriate response. Therefore, it identified that the framework is in principle in accordance with relevant IAEA safety requirements.

4.5.2 Generic issues The regulatory authority can require the report and can conduct on-site inspections, for Japan Post Co., Ltd. that provides post services pursuant to Article 16(1) of Act on Japan Post Co., Ltd. etc., and for the corresponding delivery operators, pursuant to Article 37(2) of Act on Correspondence Delivery by Private Business Operators, respectively. The regulatory authority can require the report and can conduct on-site inspections, including appropriate transport of radioactive materials etc., to the extent necessary for enforcement of each act.

5 Enforcement 5.1 Enforcement in land transport of nuclear source materials and nuclear fuel materials etc.

5.1.1 Conclusions Based on the self-assessment (SARIS) for enforcement in land transport of nuclear source materials and nuclear fuel materials etc., it finds that the Reactor Regulation Act clearly provides the requirements for the enforcement actions for land transport of nuclear source materials and nuclear fuel materials etc.

and the conditions for such enforcement actions and allow NRA to decide on these enforcement actions for noncompliance and emergency measures. Therefore, it concludes that the framework and measures for enforcement are in principle in accordance with relevant IAEA safety requirements.

14

IRRS Follow-up Mission to JAPAN 2020 5.1.2 Generic issues In Article 62-3 of the Reactor Regulation Act, in the case of land transport of nuclear source materials and nuclear fuel materials etc., it is specified that the users of nuclear source materials and nuclear operators shall: in the case of steal or loss of nuclear fuel materials, in the case of abnormal leakage of nuclear fuel materials etc. in the case of injury of persons or being likely to be so, report the above-mentioned status and the measures, as an event of accidents/malfunction, to NRA.

Upon transport of nuclear fuel materials etc., in the case where incompliance occurs that might affect transport, such information shall be promptly shared between the interested parties according to liaison system of Interagency Coordination Meeting for the Safe Transport of Radioactive Material.

In the case where NRA identifies that the measures taken by the nuclear operators etc. do not comply with the technical standard, it can order suspend the shipment and other safety and security and measures regarding nuclear fuel materials etc., pursuant to Article 59(4) of the Reactor Regulation Act.

Regarding nuclear source materials, pursuant to Article 57-7(5) of the Reactor Regulation Act, it is specified that NRA can order to take corrective measures to comply with the standard.

Additionally, in the case where it is deemed that there is an imminence peril of disasters due to nuclear fuel materials etc., and there is urgent need to prevent disasters, Article 64(3) of the Reactor Regulation Act specifies that NRA can order the nuclear operators etc. to take the measures required to prevent disasters, such as changing the location of nuclear fuel materials etc.

In the case of violation of the provisions of Article 59(2) of the Reactor Regulation Act and Orders pursuant to Article 59(4), pursuant to Article 43-3-20 etc. of the Reactor Regulation Act, NRA can order the nuclear operators etc. to rescind the permission or suspend the operation within one year.

In the case of receiving the above-mentioned report or taking the measure, according the events or the necessity, by utilizing the authority to collect report pursuant to Article 67 of the same Act, NRA can require the said nuclear operators to establish/implement the measures to investigate the cause and prevent reoccurrence and conduct on-site inspection to confirm the implementation status etc., pursuant to Article 68 of the same Act.

Report to Competent Ministers, etc. (Article 62-3 of the Reactor Regulation Act)

Suspension of shipment of nuclear fuel materials etc. and order for other necessary measures (Article 59(4) of the Reactor Regulation Act)

Order for Emergency measures (Article 64(3) of the Reactor Regulation Act)

Rescission of operation license or suspension of operation (Article 43-3-20 etc. of the Reactor Regulation Act)

Collection of reports (Article 67 of the Reactor Regulation Act)

On-site inspections, etc. (Article 68 of the Reactor Regulation Act) 5.2 Enforcement in land transport of radioisotopes etc.

5.2.1 Conclusions Based on the self-assessment (SARIS) for enforcement of transport of radioisotopes etc., it finds that the RI Act clearly provides the requirements for the enforcement actions for land transport of radioisotopes etc. and the conditions for such enforcement actions and allow NRA to decide on these enforcement actions. Therefore, it concludes that the framework and measures for enforcement are in principle in accordance with relevant IAEA safety requirements.

5.2.2 Generic issues The RI Act requires the users etc. to prevent radiation hazards in the case of transport of radioisotopes etc. outside the Sites etc. In the case where NRA identifies that the measures taken by the users etc. do not comply with the technical standard, it can order the users etc. to take the measures required for the measures to prevent radiation hazards, such as suspension of transport etc., pursuant to Article 18(4),

of the RI Act.

15

IRRS Follow-up Mission to JAPAN 2020 Additionally, in the case where NRA identifies urgent needs to prevent radiation hazards caused by radioisotopes etc., NRA can order the users etc. to take the measures required for the measures to prevent radiation hazards, such as changing the location of radioisotopes etc. and removal of contamination pursuant to Article 33 (3) of the RI Act.

Furthermore, in the case of violation of the provisions of Article 18(2) of the RI Act and the measures pursuant to Article 18(4), Article 26 of the RI Act specifies that NRA can order the users etc. to rescind the permission of radioisotopes etc. or suspend the use of radioisotopes etc.

Besides, upon transport of radioisotopes etc. outside the Sites etc., in the case where the accidents that are likely to cause radiation hazards or the ones where radiation hazards occur (hereinafter referred to as the accidents that are likely to cause radiation hazards etc..), Article 31-2 of the RI Act specifies that NRA requires the users etc. to report such accidents to NRA.

Upon transport of radioisotopes etc., in the case where incompliance occurs that might affect transport, such information shall be promptly shared between the interested parties according to liaison system to the relevant bodies established in the framework of Interagency Coordination Meeting for the Safe Transport of Radioactive Material.

In addition, Article 42 of the RI Act specifies that NRA can enforce the users to collect reports and requires the users to report all the situations of transport of radioisotopes etc. outside the Sites etc. when required to report by specifying the period, within the specified period.

Regarding coping with the accidents that are likely to cause radiation hazards etc., pursuant to Article 43-2 of the RI Act, NRA can enter the office of the users etc. or the plants or the operation site for on-site inspections regarding account books, documents and other matters related to their properties as required. NRA has the framework for the accidents that are likely to cause radiation hazards etc.

Reporting of Accidents to NRA (Article 31-2 of the RI Act)

Suspension of transport of radioisotopes etc. and other measures necessary to prevent radiation hazards (Article 18 of the RI Act)

Order for Emergency measures (Article 33(3) of the RI Act)

Rescission of operation license or suspension of operation (Article 26 of the RI Act)

Collection of Reports (Article 42 of the RI Act)

On-site inspections (Article 43-2 of the RI Act) 5.3 Enforcement in land transport of radiopharmaceuticals 5.3.1 Conclusions Regarding land transport of radiopharmaceuticals, pursuant to the Pharmaceuticals and Medical Devices Act, similarly as the RI Act, MHLW conducts enforcement required as a regulatory authority in order to incorporate IAEA safety standard.

5.3.2 Generic issues Regarding land transport of radiopharmaceuticals, MHLW specifies the rules/standards in order to incorporate IAEA safety standard pursuant to the Ministerial Ordinance/Notification on the Pharmaceuticals and Medical Devices Act. In the case where the Licensees that handle radiopharmaceuticals do not comply with the said rules/standards, MHLW can order necessary measures for improvement and the dispositions of suspension of all or part of the operation pursuant to Pharmaceutical Affairs Law as a regulatory authority. Furthermore, in the case of violation of the said dispositions, MHLW also can rescind the said License.

5.4 Enforcement in transport by post etc.

5.4.1 Conclusions Regarding transport by post etc., Regulations of Act on Japan Post Co., Ltd. etc. specifies that the regulatory authority can require reports and conduct on-site inspections or enforce the orders required for supervision (order for operation improvement for correspondence delivery operators) to the extent 16

IRRS Follow-up Mission to JAPAN 2020 required for enforcement of laws and conduct necessary regulations appropriately. Thus, it is identified that enforcement in transport by post etc. is in compliance with IAEA safety standard.

5.4.2 Generic issues The regulatory authority can require the report and can conduct on-site inspections, for Japan Post Co., Ltd. that provides post services pursuant to Article 16(1) of Act on Japan Post Co., Ltd. etc., and for the corresponding delivery operators, pursuant to Article 37(2) of the Act on Correspondence Delivery by Private Business Operators, respectively. The regulatory authority can require the report or conduct on-site inspections or orders required for supervision (order for operation improvement for correspondence delivery operators) including appropriate transport of radioactive materials etc., to the extent necessary for enforcement of the act.

6 Regulations and guides 6.1 Regulations and guides in land transport of nuclear source materials and nuclear fuel materials etc.

6.1.1 Conclusions Based on the self-assessment (SARIS) for regulations and guides in land transport of nuclear source materials and nuclear fuel materials etc., it finds that the Reactor Regulation Act requires the regulation according to the types of transport of nuclear source materials and nuclear fuel materials etc. and specify and publish as the ordinances/instructions of NRA. Therefore, it concludes that the framework and measures for the regulations and guides are in principle in accordance with relevant IAEA safety requirements, except for the following issues:

Some provisions of the application procedures of approval related to transport of nuclear fuel materials etc. specified by the notification on Technical Details for Off-Site transportation of Nuclear Fuel Materials, etc. (hereinafter referred to as Nuclear Off-Site Transportation Notice) by NRA and guides by Nuclear and Industrial Safety Agency (NISA) is not hierarchized. Therefore, NRA should modify the provisions in order to specify them appropriately.

NRA should consider rationalization of examination for package design approval related to transport, in case of examining the dual purpose cask which has obtained type designation for transport/storage (Specific Dual Purpose Cask) that is used for storage of spent fuel within the nuclear power plant site, by utilizing the submitted documents from the manufacturer upon application and examinations for type designation of the dual purpose cask.

To address these challenges, NRA will implement improvement measures, based on the Acton Plan as shown in 6.1.3.

6.1.2 Generic issues Regarding land transport of nuclear fuel materials etc., Article 59(1) of the Reactor Regulation Act specified that the nuclear operators shall take the necessary safety measures in compliance with the technical standards in the case of transport of nuclear fuel materials etc. outside the site. Regarding nuclear source materials, Article 57-7(4) of the Reactor Regulation Act specified that the licensed users of nuclear source materials shall transport in compliance with the technical standards in the case of transport of nuclear source materials outside the site.

Additionally, among these, it is specified that confirmation by NRA is required, in the case of transport of nuclear fuel package that especially requires to prevent disasters caused by nuclear fuel materials etc., based on graded approach according to radiation risk etc.

The Cabinet Order for Enforcement of the Act on the Regulation of Nuclear Source Material, Nuclear Fuel Material and Reactors (hereinafter referred to as Reactor Regulation Enforcement Cabinet Order) specifies the scope in the case where confirmation by NRA is required, the Nuclear Off-site 17

IRRS Follow-up Mission to JAPAN 2020 Transportation Ordinance specifies the technical standard required for each package, the Nuclear Off-Site Transportation Notice specifies the details of each examination conditions implemented for each package, respectively, which constitutes the legal framework related to transport regulation of nuclear fuel materials etc. Additionally, by establishing the guide documents that describe the interpretation of these legal requirements and operation policy, the legal requirements are complemented by notifying/publishing these to the nuclear operators.

As it is important for the regulatory standard related to transport of nuclear source materials and nuclear fuel materials etc. to be consistent with the international standards, NRA participates in all the committees related to IAEA safe transport standard (TRANSSC), collects information and analyzes the response including the differences between domestic international standards and international standards, and reflects latest knowledge of IAEA safe transport standard into the regulation standard of Japan.

Furthermore, upon adoption of IAEA safe transport standard into domestic regulation standard etc., for the purpose of consistency of transport of radioactive materials in general, as undermentioned, NRA has the framework to conduct necessary liaison arrangement in Interagency Coordination Meeting for the Safe Transport of Radioactive Material in which all the relevant regulatory authorities participate.

Additionally, regarding adoption of the latest IAEA safe transport regulations (SSR-6), NRA considers adoption of the said regulations together with the technical standard related to hazardous materials transportation (ICAO-TI) based on ICAO convention and the technical standard related to hazardous materials transportation based on SOLAS convention (IMDG Code), in cooperation with the relevant regulatory authorities.

The Reactor Regulation Act specifies the necessary standard and procedures for NRA to implement regulation as the ordinances/directives of NRA. NRA implements the procedures of public comments pursuant to Administrative Procedure Act, before deciding the ordinances/instructions. NRA makes this information, such as the basic approach for safety and criteria in formulating regulations/ guides or important modifications of regulatory framework, available to the public and licensees via the NRA web site, as well as for commercial reactor facilities. Therefore, ordinances and guides decided by NRA are also available for the stakeholders and to the public.

The regulations/guides related to nuclear source materials and nuclear fuel materials etc. are as follows:

Act on the Regulation of Nuclear Source Material, Nuclear Fuel Material and Reactors (Act No.

166 of 1957)

Cabinet Order for the Definition of Nuclear Source Material, Nuclear Fuel Material, and Nuclear Reactors and Radiation (Cabinet Order No. 325 of 1957)

Cabinet Order for Enforcement of the Act on the Regulation of Nuclear Source Material, Nuclear Fuel Material and Reactors (Cabinet Order No. 324 of 1957)

NRA Ordinance on Off-Site Transportation of Nuclear Fuel Materials, etc. (Ministerial ordinance issued by the Prime Ministers Office No. 57 of 1978)

NRA Ordinance on Use of Nuclear Materials (Ministerial ordinance issued by the Prime Ministers Office No. 46 of 1968)

Notification on Technical Details for Off-Site Transportation of Nuclear Fuel Materials etc. (Notice issued by Science and Technology Agency No. 5 of 1990)

Notification to Establish Dose Limits in accordance with the provisions of NRA Ordinance on Activity of Refining Nuclear Source or Nuclear Fuel Materials, etc. (Notice issued by NRA No. 8 of 2015)

Operational Guide for Confirmation of Nuclear Fuel Packages for Off-Site Transportation (Decision by Secretary-General, Nuclear Regulation Agency, No. 1402263 of Gen Kan Hai Hatsu of 2014)

Administrative Procedure Guide for Confirmation, etc. of Nuclear fuel Packages for Off-Site Transportation (Notification Gen In issued by NISA, No. 7 of March 7 of 2011)

Procedure Guide for Describing the Explanatory Documents Appended to Application Documents for Approval of Vehicle Transport, Application Documents for Approval of Packaging and Application Documents for Approval of Nuclear Fuel Package Design (Notification Gen In issued by NISA, No. 8 of March 7 of 2011)

Guidelines for Quality Management of Manufacturing Method of the Packaging (Notification Gen In issued by NISA, No. 1 of June 10 of 2008) 18

IRRS Follow-up Mission to JAPAN 2020 Additionally, amendment of the NRA Commercial Reactors Ordinance enacted in April 2 of 2019 to add the cask used both for transport/storage of spent fuel within the nuclear power plant site (within site) as the specific equipment of type designation system. Due to this amendment, it is available to obtain approval of the compliance with the technical standard for storage and a part of the compliance with the technical standard for transport in advance, through the application for type designation of the cask used both for transport/storage by the manufacturer of the cask. Thus, NRA considers rationalization of the examination for the application of package design approval related to transport for the said cask used both for transport/storage.

6.1.3 Action plan No. 2 Basis (B2) The IAEA Safety Standard stipulates that the regulatory body shall establish or adopt regulations and guides to specify the principles, requirements and associated criteria for safety upon which its regulatory judgements, decisions and actions are based GSR Part1 (Rev.1) R32, Irrespective of the degree to which the regulatory body has developed prescriptive regulations, the regulatory body is required to give consideration to supplementing its regulations with guidance documents GS G 1.5 3.11 , the regulatory body shall issue guidance on the format and content of the documents to be submitted by the applicant in support of an application for an authorization. GSR Part1 (Rev.1) 4.34.

Recommendation (R2) Some provisions of the application procedures of approval related to transport of nuclear fuel materials etc. specified by the Nuclear Off-Site Transportation Notice by NRA and guides by Nuclear and Industrial Safety Agency (NISA) is not hierarchized. Therefore, NRA should modify the provisions in order to specify them appropriately.

Action Plan (A2) Regarding some provisions of the application procedures of approval related to transport of nuclear fuel materials etc. that are not hierarchized, NRA will specify these provisions on required procedures by partly amending the Nuclear Off-Site Transportation Notice.

No. 3 Basis (B3) The IAEA Safety Standard stipulates that the licensing process should be established in a systemic way to facilitate efficient progression of regulatory activities. SSG-12 2.6 Recommendation (R3) NRA should consider rationalization of examination for package design approval related to transport, in case of examining the dual purpose cask which has obtained type designation for transport/storage (Specific Dual Purpose Cask) that is used for storage of spent fuel within the nuclear power plant site, by utilizing the submitted documents from the manufacturer upon application and examinations for type designation of the dual purpose cask.

Action Plan (A3) Regarding the Specific Dual Purpose Cask obtained type designation, NRA will rationalize the examinations in the case of obtaining the package design approval related to transport.

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IRRS Follow-up Mission to JAPAN 2020 6.2 Regulations and guides in land transport of radioisotopes etc.

6.2.1 Conclusions Based on the self-assessment (SARIS) for regulations and guides related to transport of radioisotopes etc., pursuant to the RI Act, it finds that NRA announces the regulatory requirements according to the type of transport of radioisotopes etc. by complementing by the notices etc. Therefore, it is identified that is regulations and guides related to transport of radioisotopes etc.is in compliance with IAEA safety standard.

6.2.2 Generic issues Regarding land transport of radioisotopes etc., the RI Act specifies that the users etc. shall take the necessary safety measures to prevent radiation hazards in compliance with the technical standards in the case of transport of radioisotopes etc. outside the Sites etc. Specifically, Regulations on enforcement of the said Act specifies the scope and technical standard required for the standard and each packaging in the case where NRA requires confirmation related to transport. Additionally, the standard for each packaging is specified in the Notification on Technical Details for Off-Site transportation of Radioisotopes etc. Therefore, NRA has the legal framework related to regulations for transportation of radioisotopes etc.

Furthermore, NRA specifies the notification documents that describe the procedures for these legal requirements as the internal regulations of the administration and the legal requirements are complemented by indicating these to the users etc.

In the case where IAEA safe transport regulations etc. are amended, such amendments shall be incorporated into domestic laws and regulations as required. The information of the said amendments shall be shared in Interagency Coordination Meeting for the Safe Transport of Radioactive Material by the relevant ministries and agencies.

Moreover, after gaining approval in the open meetings of NRA, according to the contents of amendment, then sending to the procedures of public comments pursuant to Administrative Procedure Law and receiving the decision by NRA based on the opinions obtained, the procedures for amendment of the laws and regulations shall be proceeded. The amended domestic laws and regulations shall be released on the NRA website, as well as on the official gazette.

6.3 Regulations and guides in land transport of radiopharmaceuticals 6.3.1 Conclusions Regarding land transport of radiopharmaceuticals, pursuant to Ministerial Ordinance/Notifications based on the provisions of the Pharmaceuticals and Medical Devices Act, similarly as the RI Act, MHLW conducts regulations/guides required by specifying regulations/standards in order to incorporate IAEA safety standards.

6.3.2 Generic issues Regarding land transport of radiopharmaceuticals, MHLW specifies the rules/standards in order to incorporate IAEA safe standard pursuant to Ministerial Ordinance/Notification based on the provision of the Pharmaceuticals and Medical Devices Act, similarly as the RI Act. In the case of amendment of IAEA safety standards etc., as well as the RI Act, necessary amendment regarding the said the Ministerial Ordinance/Notification shall be considered. Additionally, in the case of amendment of the said the Ministerial Ordinance/Notification, such amendment shall be notified to the relevant operators/bodies etc.

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IRRS Follow-up Mission to JAPAN 2020 6.4 Regulations and guides in transport by post etc.

6.4.1 Conclusions Regarding transport by post etc., MIC specifies the rules/standards by the Postal Act etc. or the regulations/notifications based on the said Act. These are specified in compliance with Convention of Universal Postal Union (UPU) etc. that incorporates IAEA safe standard. Therefore, it is identified that transport by post etc. is in compliance with IAEA safe standard.

6.4.2 Generic issues MIC specifies the rules/standards by the Postal Act etc. or the regulations/notifications based on the said Act, which are specified in compliance with convention of Universal Postal Union (UPU) etc. that incorporates IAEA safety standards. Additionally, regarding transport by the correspondence delivery, MIC specifies the rules/standards by Act on Correspondence Delivery by Private Business Operators and the regulations/notifications based on the said Act, as well as the Postal Act etc., which have the same contents with the ones of the Postal Act etc.

7 Emergency response 7.1 Emergency response in land transport of radioactive materials 7.1.1 Conclusions Based on the self-assessment (SARIS) for emergency response for land transport of radioactive materials, it found that the regulatory framework is well established in advance to regulate emergency response including collaboration with the relevant bodies. Therefore, it is identified that the framework and measures for emergency response is in accordance with relevant IAEA safety requirements, except in the following maters:

In the existing system in land transport of nuclear fuel materials, despite the results of risk assessment quoted in Emergency Preparedness for Nuclear facilities etc. determined by Nuclear Safety Commission in 2003, the said assessment has not been updated. NRA should consider accidents that can be reasonably assumed based on actual present situations of the transport and review the NRA Guide for Emergency Preparedness and Response etc.

The existing system of land transport of radioactive materials is developed in advance for the measures to be taken by the relevant organizations and sharing of roles based on the framework of the existing laws and regulations etc. However, it is needed for NRA to clarify the procedures for the initial response including collaboration with the relevant organizations for more appropriate response based on the framework of the existing laws and regulations etc.

To address these challenges, NRA will implement improvement measures, based on the Acton Plan as shown in 7.1.3.

7.1.2 Generic issues Regarding emergency response in land transport of radioactive materials, based on the competent authorities laws and regulations related to land transport of radioactive materials including NRA, in the case where the accidents of transport of radioactive materials occur or are likely to occur, the nuclear operators are required to report to the competent authorities and take necessary measures etc.

Additionally, based on the document about Measures Regarding Safety Measures Against Accidents of Transport of Radioactive Materials prepared by Interagency Coordination Meeting for the Safe Transport of Radioactive Material that composes of the departments and divisions in charge of the 21

IRRS Follow-up Mission to JAPAN 2020 competent authorities related to safe transport of radioactive materials and the framework of Act on Special Measures Concerning Nuclear Emergency Preparedness, the following matters are organized in advance by specifying the sharing of roles of the relevant organizations; Notification/liaison system Organizational system that consists of the relevant organizations Collecting/summarizing/sharing of information Dispatch of the staff and experts to the site Response on the site (lifesaving, fire extinguishing, contamination prevention, restricted entry etc.)

Public relation Measures for restoration from nuclear emergency (termination of restrictions, evaluation of dose exposure, health consultation, measures against reputational damage etc.)

At the occurrence of the accidents, the relevant organizations will promptly respond in collaboration with these frameworks.

[Measures Regarding Safety Measures Against Accidents of Transport of Radioactive Materials (Interagency Coordination Meeting for the Safe Transport of Radioactive Material), Act on Special Measures Concerning Nuclear Emergency Preparedness, Basic Plan for Emergency Preparedness, NRA Guide for Emergency Preparedness and Response, Manual for Nuclear Emergency Preparedness and Response (transport version)]

7.1.3 Action Plan No. 4 Basis (B4) IAEA standard specifies that the competent authority should periodically access the risk of an accident involving the transport of radioactive materials and its potential consequences. Emergency planning by the competent authority and other responsible authorities, usually organizations with responsibility for public health and safety, should be based on these and other relevant assessments.

TS-G-1.5 4.99 Recommendation (R4) In the existing system in land transport of nuclear fuel materials, despite the results of risk assessment quoted in Emergency Preparedness for Nuclear facilities etc. determined by Nuclear Safety Commission in 2003, the said assessment has not been updated. NRA should consider accidents that can be reasonably assumed based on actual present situations of the transport and review the NRA Guide for Emergency Preparedness and Response etc.

Action Plan (A4) The accidents that can be reasonably assumed based on the actual situations of transport should be assessed as the risk of the accidents related to transport of nuclear fuel materials and their potential effects.

Based on the results of such assessment, NRA should consider enhancement of descriptions of necessary protective measures in the NRA Guide for Nuclear Emergency Preparedness and Response.

Additionally, NRA assesses and reviews the NRA Guide for Nuclear Emergency Preparedness and Response etc., as needed.

No. 5 Basis (B5) IAEA safety standard specifies that in the event of accidents or incidents during transport of radioactive materials, emergency provisions, as established by relevant national and/or international organizations, shall be observed to protect persons, property and the environment. Appropriate guidelines for such provisions are contained in TS-G-1.2 (ST-3) SSR-6 304, detailed recommendations on emergency planning and preparedness are provided in TS- G-1.2 TS-G-1.5 4.100, and When a transport 22

IRRS Follow-up Mission to JAPAN 2020 accident involving radioactive material occurs, several governmental organizations, the consignor, the carrier and their personnel may have responsibilities to act to mitigate its consequences. In most transport accident situations this response consists of life saving, medical aid, fire suppression and control, and the normal police work associated with any accident. In addition, consideration should be given to calling in specialized organizations trained to deal with radioactive material to assess the accident and implement the protective measures used to contain, control or eliminate any radiological hazard. The degree of involvement of the various organizations may vary during the progress of the operation. TS-G-1.2 (ST-3) 3.1 Recommendation (R5) The existing system of land transport of radioactive materials is developed in advance for the measures to be taken by the relevant organizations and sharing of roles based on the framework of the existing laws and regulations etc. However, it is needed for NRA to clarify the procedures for the initial response including collaboration with the relevant organizations for more appropriate response based on the framework of the existing laws and regulations etc.

Action Plan (A5) NRA will develop the manual to clarify the procedures for the initial response including collaboration with the relevant organizations.

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IRRS Follow-up Mission to JAPAN 2020 8 Radiation protection 8.1 Radiation protection in land transport of nuclear source materials and nuclear fuel materials etc.

8.1.1 Conclusions Based on the self-assessment (SARIS) for land transport of nuclear fuel materials etc., it finds that the requirements such as standards are based on graded approach according to radiation risk under the Reactor Regulation Act. Therefore, it concludes that the framework for land transport of nuclear fuel materials etc. is in principle in accordance with relevant IAEA safety requirements.

8.1.2 Generic issues The licensed users of nuclear source materials and nuclear operators etc. are required to control the occupational exposure not to exceed the limits, pursuant to the Reactor Regulation Act, by measuring exposure dose of occupationally exposed persons that create packaging within the controlled area and record/keep the exposure dose of the occupationally exposed persons. The exposure limits of occupationally exposed persons shall be specified as 50 mSv per year and 100 mSv in five years, pursuant to Article 5 of the Notification to Establish Dose Limits in Accordance with the provisions of NRA Ordinance on Activities of Refining Nuclear Source or Nuclear Fuel Materials, etc. (Nuclear Dose Limit Notice) In the case where the exposure dose exceeds the said limits, the licensed users of nuclear source materials and nuclear operators etc. shall report to NRA, based on Article 62-3 of the Reactor Regulation Act. And the licensed users of nuclear source materials and nuclear operators etc.

shall record/keep the exposure dose of the occupationally exposed persons, and NRA shall confirm the said records upon on-site inspections.

Additionally, regarding land transport of nuclear source materials, based on the actual situation of transport at present according to graded approach, NRA does not require to establish radiation protection plan due to low radiation risk.

8.2 Radiation protection in land transport of radioisotopes etc.

8.2.1 Conclusions Based on the self-assessment (SARIS) for land transport of radioisotopes etc., it finds that the requirements such as standards are based on graded approach according to radiation risk under the RI Act. Therefore, it concludes that the framework for land transport of radioisotopes etc. is in principle in accordance with relevant IAEA safety requirement.

8.2.2 Generic issues The licensed users of radioisotopes etc. are required to control the occupational exposure not to exceed the limits, pursuant to the RI Act, by measuring exposure dose of occupationally exposed persons that create packaging within the controlled area and record/keep the exposure dose of the occupationally exposed persons. The exposure limits of occupationally exposed persons shall be specified as 50 mSv per year and 100 mSv in five years, pursuant to Article 5 of the Notification that Specify Standards for amount of Radioisotopes based on the provisions of the RI Ordinance etc. In the case where the exposure dose exceeds the said limits, the licensed users of radioisotopes and notification users etc. shall report to NRA, based on Article 31-2 of the RI Act. And the licensed users of radioisotopes etc. shall record/keep the exposure dose of the occupationally exposed persons, and NRA shall confirm the said records upon on-site inspections.

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IRRS Follow-up Mission to JAPAN 2020 8.3 Radiation protection in land transport of radiopharmaceuticals 8.3.1 Conclusions Regarding radiation protection in land transport of radiopharmaceuticals, pursuant to Ministerial Ordinance/Notification based on the provisions of the Pharmaceuticals and Medical Devices Act, similarly as the RI Act, MHLW performs necessary regulations appropriately by specifying rules/standard to incorporate IAEA safe standard.

8.3.2 Generic issues In order to appropriately prevent radiation hazards upon transport of radiopharmaceuticals, pursuant to Ministerial Ordinance/Notification on the Pharmaceuticals and Medical Devices Act, MHLW requires consigner and consignees to specify radiation protection programme that includes the matters regarding radiation dose measurement method and dose assessment and the matters etc. regarding separation and radiation protection from package. Additionally, each licensee is required to appoint the manager who is responsible for supervision on the prevention of radiation hazards.

8.4 Radiation protection in transport by post etc.

8.4.1 Conclusions Regarding transport by post etc., MIC can require reports regarding whether appropriate training is conducted pursuant to the regulations of Act on Japan Post Co., Ltd. etc. In addition, MIC requires the correspondence delivery operators to conduct education/training pursuant to the ministerial ordinance.

Therefore, it is concluded that radiation protection in transport by post etc. is in accordance with relevant IAEA safety requirements.

8.4.2 Generic issues It is specified that MIC can require the regulatory authorities to report whether training for appropriate transport of radiation materials etc. is conducted or not, for the Japan Post Co., Ltd., pursuant to Article 16 of Act on Japan Post Holdings Co., Ltd. etc. and for the correspondence delivery operators, pursuant to the Article 37 of regulations related to Act on Correspondence Delivery by Private Business Operators.

As the conditions of the approval of Article 31(2)(iv) of the correspondence management rules of enforcement regulations of Act on Correspondence Delivery Operator, implementation of education and training for the correspondence delivery operators is required.

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IRRS Follow-up Mission to JAPAN 2020 List of SARIS Documentary Evidence Documentary Evidence Applicable Provisions 1 the Act on the Regulation of Nuclear Source Article 43-3-20~22, Article 57-7, Article 59, Concerning the Reactor Regulation Act Material, Nuclear Fuel Material and Reactors Article 62-3, Article 64, Article 67, Article 68 (Act No. 166 of 1957) 2 the Act on the Regulation of Nuclear Source Amended Article 61-2-2, Amended Article Material, Nuclear Fuel Material and Reactors 68(2)

(Act No. 166 of 1957) amended 3 the Cabinet Order for the Definition of Nuclear Article 1, Article 2 Source Material, Nuclear Fuel Material, Nuclear Reactors and Radiation (the Cabinet Order No. 325 of 1957) 4 the Cabinet Order for Enforcement of the Act Article 2, Article 3, Article 47, Article 48, on the Regulation of Nuclear Source Material, Article 49 Nuclear Fuel Material and Reactors (Cabinet Order No. 324 of 1957) 5 the NRA Ordinance on Off-Site Transportation Full text of Nuclear Fuel Materials, etc. (Ministerial ordinance issued by the Prime Ministers Office No. 57 of 1978) 6 the NRA Ordinance on Off-Site Transportation Amended proposal Article 17-2, Amended of Nuclear Fuel Materials, etc. (Ministerial proposal Article 19, Amended proposal Article ordinance issued by the Prime Ministers Office 20, Amended proposal Article 21, Amended No. 57 of 1978) Amendment proposal in proposal Article 22 public comment 7 the NRA Ordinance Concerning the Installation Article 67, Article 79 and Operation of Commercial Power Reactors (Ordinance for Ministry of International Trade and Industry No. 11 of 1978) 8 the NRA Ordinance on Use of Nuclear Source Article 2(v) and (xii), Article 3, Article 5 Materials (Ministerial ordinance issued by the Prime Ministers Office No. 46 of 1968) 9 the Notification on Technical Details for Off- Full text Site Transportation of Nuclear Fuel Materials, etc. (Notice issued by Science and Technology Agency No. 5 of 1990) 10 the Notification to Establish Dose Limits in Article 5 Accordance with the Provisions of NRA Ordinance etc. on Activity of Refining Nuclear Source or Nuclear Fuel Materials (Notice issued by NRA No. 8 of 2015) 11 Operational Guide for Confirmation of Nuclear Full text Fuel packages for Off-Site Transportation (Decision by Secretary-General, Secretariat of NRA, No. 1402263 of Gen Kan Hai Hatsu of 2014) 12 Administrative Procedure Guide for Full text Confirmation, Etc. of Nuclear Fuel Packages for Off-Site Transportation (METI NISA)

(Notification Gen In NISA-316a-11-1, No. 7 of March 7 of 2011) 26

IRRS Follow-up Mission to JAPAN 2020 Documentary Evidence Applicable Provisions 13 Procedure Guide for Describing the Full text Explanatory Documents Appended to Application Documents for Approval of Vehicle Transport, Application Documents for Approval of Packaging and Application Documents for Approval of Nuclear Fuel Package Design (METI NISA) (Notification Gen In NISA-316a-11-2, No. 8 of March 7 of 2011) 14 Guidelines for Quality Management of Full text Manufacturing Method of the Packaging (METI NISA) (Notification Gen In NISA-316a-08-2, No. 1 of June 10 of 2008) 1 the Act on the Regulation of Radioisotopes, etc. Article 18, Article 20, Article 22, Article 23, Concerning the RI Act (Act No. 167 of 1957) Article 26, Article 31-2, Article 33, Article 42, Article 43-2 2 the NRA Ordinance for Enforcement of the Act Article 1, Article 18-3, Article 18-4, Article 18-on Regulation of Radioisotopes, etc. 5, Article 18-6, Article 18-7, Article 18-12, (Ministerial ordinance issued by the Prime Article 18-15, Article 18-16, Article 18-17, Ministers Office No. 56 of 1960) Article 18-18, Article 18-19, Article 18-20, Article 20, Article 21-2, Article 22, Article 24, Article 39 3 the Notification on Technical Details for Off- Full text Site Transportation of Radioisotopes, etc.

(Notice issued by Science and Technology Agency No. 7 of 1990) 4 the Notification on the Details of Standards Attached Table 1 - Table 6 Concerning the Carriage of Radioactive Material by Ships (Notice of Ministry of Transport of 1977) 5 the Notification to Specify Standards for Article 5 Amount of Radioisotopes (Notice issued by Science and Technology Agency No. 5 of 2000) 6 Regulatory Guide for Reviewing Quality Full Text Control of the Manufacture of Nuclear Fuel Material Transport Containers (Notice issued by Ministry of Education, MEXT, Director of Nuclear Safety Division, Science and technology Policy Bureau, 18, Gen An, No.

139, January 11, 2007) 27

IRRS Follow-up Mission to JAPAN 2020 Documentary Evidence Applicable Provisions Concerning the Act on Securing Quality, Efficacy and Safety Concerning the Postal Act etc.

1 Act on Securing Quality, Efficacy and Safety of Article 4(1) and (4), Article 9 (1), Article 12(1)

Products Including Pharmaceuticals and and (2), Article 13(1) and (3), Article 18(1) and Medical Devices (Act No. 145 of August 10, (2), Article 23-2(1) and (2), Article 23-2-15(1) 1960) and (2), Article 24(1) and (2), Article 25(iii),

Article 36-2(1), Article 69(1) and (2), Article 72-4(1), Article 75(1), Article 75-2(1) 2 Regulation on Manufacture and Handling of Article 1, Article 2(6) and (7), Article 6, Article Radiopharmaceuticals (February 1, 1961) 12, Article 15, Attached Table 1 (Order of the Ministry of Health and Welfare No. 4) 3 Standards for Transport of Radioactive Full text Materials (November 24, 2005) (Public Notice of the Ministry of Health, Labour and Welfare No. 491) 4 Standards for Activities of Radioactive Article 9 of Products Including Pharmaceuticals and Medical Devices Materials (December 26, 2000) (Public Notice of the Ministry of Health and Welfare No. 399) 1 the Postal Act (Act of No. 165 of 1947) Article 12 2 the Public Notice on Designation of Explosive, 9 Inflammable or Other Dangerous Substances under Article 12, Item (i) of the Postal Act (Public Notice of the Ministry of Communications No. 384 of 1947) 3 the Act on Correspondence Delivery by Private Article 37(2), Article 48 Business Operators (Act No. 99 of 2002) 4 the Public Notice on Designation of Explosive, Full text Inflammable or Other Dangerous Substances under Article 48, Paragraph (1), Item (i) of the Act on Correspondence Delivery by Private Business Operators (Public Notice of the Ministry of Internal Affairs and Communications No. 203 of 2003) 5 the Act on Japan Post Co., Ltd. (Act No. 100 of Article 16(1) 2005) 6 Regulation for Enforcement of the Act on Article 31(2)(iv)

Correspondence Delivery by Private Business Operators (Order of the Ministry of Internal Affairs and Communications No. 27 of 2003) 7 Universal Postal Convention (Convention No. Article 19 16 of 2017) 8 Convention Regulations19-006 28

IRRS Follow-up Mission to JAPAN 2020 Documentary Evidence Applicable Provisions 1 the Act on Special Measures Concerning Article 1, Article 2, Article 3, Article 4, Article Concerning Act on Special Measures Concerning Nuclear Emergency Preparedness Nuclear Emergency Preparedness (Act No. 156 4-2, Article 5, Article 6, Article 10, Article 15, of 1999) Article 25, Article 26, Article 27, Article 31, Article 32 2 the Cabinet Order for Enforcement of the Article 4, Article 5, Article 6, Article 9 Nuclear Emergency Act (Cabinet Order No.

195 of 2000) 3 Order on events, etc. pertaining to transport Article 1, Article 2, Article 3, Article 4 outside the nuclear site, which nuclear emergency preparedness manager should notify, based on Act on Special Measures Concerning Nuclear Emergency Preparedness (Ministerial Order No. 2 by MEXT, METI, MLIT) 4 the NRA Guide for Emergency Preparedness Preamble, 3 (6) and Response (July 3, 2019 NRA) 5 the Manual for Nuclear Emergency Full text Preparedness and Response (transport version) 6 Basic Plan for Emergency Preparedness (May The 12th volume Chapter 1, section 6, the 12th of 2019, Central Disaster Prevention Council) volume Chapter 2, section 10 7 Emergency Preparedness for Nuclear Facilities Full text etc. (partly amended on October of 2008, Nuclear Safety Commission) "Virtual Accident Evaluation Concerning Transport of Nuclear Fuel Materials etc."

8 Order regarding notification procedures, etc. for Article 1, Article 2, Article 3 events involved in transport outside the nuclear site that nuclear emergency preparedness manager should notify based on the Act on Special Measures Concerning Nuclear Emergency Preparedness (Ministerial Order by MEXT, METI, MLIT No. 3 of 2012) 29

Enclosure 6 to E-59637 French Standards Sent as separate enclosure

Enclosure 7 to E-59637 Transnuclear Tokyo Statement of Proprietary Information Pursuant to 49 CFR 7.14, 49 CFR 105.30, and 10 CFR 2.390

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