SSG-78 Compliance Assurance for the Safe Transport of Radioactive Material

The safety principles for protecting people — individually and collectively — society and the environment from radiation risks, both at present and in the future;

The types of facilities and activities that are included within the scope of the framework for safety;

The type of authorization that is required for the operation of facilities and for the conduct of activities, in accordance with a graded approach;

The rationale for the authorization of new facilities and activities, as well as the applicable decision making process;

Provision for the involvement of interested parties and for their input to decision making;

Provision for assigning legal responsibility for safety to the persons or organizations responsible for the facilities and activities, and for ensuring the continuity of responsibility where activities are carried out by several persons or organizations successively;

The establishment of a regulatory body, as addressed in Requirements 3 and 4 [of GSR Part 1 (Rev. 1) [6]];

Provision for the review and assessment of facilities and activities, in accordance with a graded approach;

The authority and responsibility of the regulatory body for promulgating (or preparing for the enactment of) regulations and preparing guidance for their implementation;

(Provision for the inspection of facilities and activities, and for the enforcement of regulations, in accordance with a graded approach;

Provision for appeals against decisions of the regulatory body;

Provision for preparedness for, and response to, a nuclear or radiological emergency;

Provision for an interface with nuclear security;

Provision for an interface with the system of accounting for, and control of, nuclear material;

Provision for acquiring and maintaining the necessary competence nationally for ensuring safety;

…….

(18) The specification of offences and the corresponding penalties;

(19) Provision for controls on the import and export of nuclear material and radioactive material, as well as for their tracking within, and to the extent possible outside, national boundaries, such as tracking of the authorized export of radioactive sources.”

The general characteristics of a competent authority with responsibility for safety (see paras 2.1–2.29 of GSG‑12 [3]).

Management for safety, focused on leadership for safety and safety culture aspects (see paras 3.1–3.26 of GSG‑12 [3]).

The organizational aspects necessary for the implementation of the core regulatory functions of a competent authority, including the following:

The organizational aspects necessary to support the regulatory functions of a competent authority, including the following:

The characteristics of an integrated management system necessary for an effective and efficient competent authority (see paras 5.1–5.70 of GSG‑12 [3]).

The necessary staffing and competences that should be in place to enable the competent authority to effectively perform its functions and to discharge its responsibilities (see paras 6.1–6.86 of GSG‑12 [3]).

Development and provision of regulations and guides (see paras 4.5 and 4.6 of GSG‑12 [3]);

Notification and authorization, including approvals (see paras 4.7–4.10 of GSG‑12 [3]);

Regulatory review and assessment (see paras 4.11 and 4.12 of GSG‑12 [3]);

Regulatory inspection (see paras 4.13–4.16 of GSG‑12 [3]);

Enforcement (see paras 4.17–4.20 of GSG‑12 [3]);

Emergency preparedness and response (see paras 4.21 and 4.22 of GSG‑12 [3]);

Communication and consultation with interested parties (see paras 4.23 and 4.24 of GSG‑12 [3]).

Administrative support, including human resources, finance, management of documents and records, and equipment purchasing and control (see para. 4.26 of GSG‑12 [3]);

Legal assistance (see paras 4.27–4.30 of GSG‑12 [3]);

Arrangements for contracting external expert support, where needed (see paras 4.40–4.43 of GSG‑12 [3]);

International cooperation (see paras 4.49–4.54 of GSG‑12 [3]).

Containment of the radioactive contents;

Criticality safety;

Radiation safety, including shielding analysis;

Thermal analysis;

Materials science and mechanical or structural engineering;

Management system;

Packaging testing;

Packaging manufacturing;

Packaging maintenance⁶;

Packaging and transport operations;

Inspection and enforcement;

Emergency preparedness and response.

Developing and managing the competences of the competent authority staff, including through training;

Managing external expert support.

Agencies with responsibilities for transport;

Agencies with responsibilities for dangerous goods;

Agencies with responsibilities for health and safety;

Agencies with responsibilities for radiation protection;

Agencies with responsibilities for emergency preparedness and response;

Law enforcement agencies;

Customs agencies;

Postal authorities;

National research institutes and institutes for materials testing;

Institutions that provide training and education.

An exchange of information regarding existing regulations for the transport of radioactive material;

An exchange of information on changes to national laws and regulations as well as changes to the Transport Regulations;

A complete programme of training for personnel at all levels;

Consistent application of inspection and enforcement relating to compliance assurance;

A regular review of all measures for emergency response, including the responsibilities of the competent authority, the industry for the transport of radioactive material and other relevant agencies;

A suitable forum for the discussion and resolution of issues relating to the Transport Regulations and compliance assurance;

An exchange of information regarding threats and vulnerabilities.

Agencies that serve as the regulatory body for nuclear safety, radiation safety and radioactive waste safety, which includes the use and storage of radioactive material;

Agencies with responsibilities for transport;

Agencies with responsibilities for specific modes of transport;

National agencies involved in nuclear material accounting and control;

National agencies with responsibilities for the security of radioactive material (including nuclear material);

Customs agencies;

Environmental agencies;

Agencies with responsibilities for dangerous goods;

Agencies with responsibilities for radioactive or hazardous waste;

Agencies with responsibilities for emergency preparedness and response;

Other technical regulatory bodies;

Agencies with responsibility for law enforcement and the prosecution of criminal activities.

Liaise closely with the national agencies responsible for transport security;

Review proposed security measures for the transport of radioactive material to ensure that they do not compromise transport safety;

Incorporate, as appropriate, requirements on nuclear security mentioned in paras 2.25 and 2.26 into national requirements for the transport of radioactive material (including nuclear material), taking into account recommendations and guidance as described in para. 2.27;

If security arrangements are reviewed during inspections or as part of a review of an application for authorization by the competent authority, use available checklists and procedures that address security arrangements;

Ensure that its staff members receive training in nuclear security and are trustworthy, as appropriate, for their duties and responsibilities.

Recommendations on the Transport of Dangerous Goods, Model Regulations (‘United Nations Model Regulations’ or ‘The Orange Book’) [12];

Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO‑TI) [13], which amplify the basic provisions of annex 18 to the Convention on International Civil Aviation (Chicago Convention) [19];

International Maritime Dangerous Goods Code (IMDG Code) [14], which provides detailed regulations for the carriage of dangerous goods in packaged form by sea under chapter VII of the International Convention for the Safety of Life at Sea (SOLAS) [20];

Regulations to the Universal Postal Convention, which provide detailed requirements for the exceptional sending of dangerous goods (e.g. radioactive material) by international postal service based on the provisions of the Universal Postal Convention [21].

The Agreement Concerning the International Carriage of Dangerous Goods by Road (ADR) [22];

The Convention Concerning International Carriage by Rail [23] and its appendix C, the Regulations Concerning the International Carriage of Dangerous Goods by Rail [24];

The European Agreement Concerning the International Carriage of Dangerous Goods by Inland Waterways [25];

The MERCOSUR/MERCOSUL Agreement of Partial Reach to Facilitate the Transport of Dangerous Goods, signed by the Governments of Argentina, Brazil, Paraguay and Uruguay in 1994 [26];

The Agreement on International Goods Traffic by Rail [27] and its annex 2.

The key principles to be followed for the initial development and subsequent review and revision of regulations and guides, as necessary, including the involvement of interested parties and the consideration of international or national standards and operating experience, as well as developments in transport practices;

Topics that should be addressed in regulations and guides, for example the authorization process, the documentation to be submitted to the competent authority, and the enforcement policy;

The promotion of regulations and guides to interested parties.

Issuing of approvals;

Inspections of the management systems of users of the Transport Regulations;

Training and distribution of information;

Assessment of designs;

Inspection of testing, which should include the direct observation of specific tests;

Inspection of transport operations, which should include direct observation of transport activities;

Inspection of manufacturing, which should include direct observation of specific steps in the manufacturing process;

Inspection of maintenance arrangements, which should include direct observation of maintenance activities;

Emergency preparedness and response;

Enforcement actions and investigations of incidents;

Regular review of the national legal framework, including national and international regulations;

Liaison and cooperation with other government agencies (see paras 2.17–2.22).

Activities relating to review and assessment, including the issuing of certificates of approval;

Activities relating to inspection and enforcement;

Activities relating to emergency preparedness and response.

Determination or confirmation of the size and state of the existing industry for the transport of radioactive material;

Determination or confirmation of the existing legal powers, independence and other resources available to the competent authority;

Establishment of liaison with government agencies or organizations having a legitimate interest in or an interface with aspects of the transport of radioactive material;

Provision of a sound legal framework to enable the effective functioning of the competent authority;

Formal confirmation of the working relationships between other government agencies and other organizations in respect of the transport of radioactive material;

Gathering of further detailed information on the size of the industry for the transport of radioactive material, including information on package types and number of movements;

Formal specification of the size, structure and resources of the competent authority and development of a management system for the competent authority;

Initial training of personnel of the competent authority and other personnel involved in the enforcement of regulations;

Creation or adoption of national regulations for the transport of radioactive material (with provision for all package types, transport operations and modes of transport);

Development and implementation of an initial compliance assurance programme;

Distribution of information to all parts of the industry regarding the competent authority’s policies, regulations and guides for the transport of radioactive material;

Collection of initial evidence of compliance with the Transport Regulations by means of the applicable activities described in para. 4.2;

Accumulation and review of evidence of compliance on a continual basis.

Radioactive material classification;

Import and export operations;

All relevant modes of transport;

All relevant package types;

Associated package certificates of foreign origin, if applicable;

Maintenance and removal from service of a packaging.

Designs for:

Special arrangements.

Certain shipments.

Radiation protection programmes for special use vessels.

Calculation of radionuclide values not listed in table 2 of the Transport Regulations.

Calculation of alternative activity limits for an exempt consignment of instruments or articles.

Special form radioactive material;

Low dispersible radioactive material;

Fissile material excepted under para. 417(f) of the Transport Regulations;

Packages containing 0.1 kg or more of uranium hexafluoride;

Packages containing fissile material, unless excepted by paras 417(a–f), 674 or 675 of the Transport Regulations;

Type B(U) packages and Type B(M) packages;

Type C packages.

The design of special form radioactive material;

The design of packages containing 0.1 kg or more of uranium hexafluoride that meet the requirements of paras 631–633 of the Transport Regulations;

Type B(U) and Type C package designs, except package designs for fissile material and Type B(U) package designs for low dispersible radioactive material.

The determination of basic radionuclide values not listed in table 2 of the Transport Regulations;

The design of low dispersible radioactive material;

The design of material excepted from fissile classification under para. 417(f) of the Transport Regulations;

The design of packages containing 0.1 kg or more of uranium hexafluoride that meet the requirements of para. 634 of the Transport Regulations;

The design of packages for fissile material that are not excepted by any of the paras 417(a)–(f), 674 and 675 of the Transport Regulations;

The design of Type B(U) packages for low dispersible radioactive material;

The design of Type B(M) packages;

Alternative activity limits for an exempt consignment of instruments or articles;

Package designs approved by the competent authority under the provisions of the 1985 Edition or the 1985 Edition (As Amended 1990) of the Transport Regulations;

After 31 December 2025, package designs approved by the competent authority under the provisions of the 1996 Edition, 1996 Edition (Revised), 1996 (As Amended 2003), 2005, 2009 and 2012 Editions of the Transport Regulations;

The shipment of Type B(M) packages not conforming with the requirements of para. 639 of the Transport Regulations or designed to allow controlled intermittent venting;

The shipment of Type B(M) packages containing radioactive material with an activity greater than 3000A₁ or 3000A₂, as appropriate, or 1000 TBq, whichever is lower;

The shipment of packages containing fissile material, if the sum of the criticality safety indexes of the packages in a single freight container or in a single conveyance exceeds 50, except for shipments excluded from this requirement in accordance with para. 825(c) of the Transport Regulations;

Radiation protection programmes for shipments by special use vessels in accordance with para. 576(a) of the Transport Regulations;

The shipment of SCO‑III (surface contaminated object of the group SCO‑III);

Consignments transported under special arrangement.

An organizational structure and competent personnel suitable for administering and conducting activities in the management system;

The capability to develop all procedures and instructions needed to guide, control and verify the conduct and evolution of activities in the management system;

The means to develop, maintain and make accessible to the competent authority all necessary records and documentation of the management system;

The performance of activities to ensure compliance with the Transport Regulations and any additional national requirements.

The design of a package is accurately described by engineering drawings, material specifications and records of the methods of construction. For package designs requiring approval by the competent authority, this information is a required part of the application for the certificate of approval (section VIII of the Transport Regulations). For package designs that do not require approval by the competent authority, the information should be provided to the competent authority upon request.

The packagings are manufactured in accordance with the design. For package designs that require approval by the competent authority, changes or modifications in the construction methods for the packaging or the materials of construction are required to be approved by the competent authority before use of the package (see para. 503 of the Transport Regulations). For package designs that do not require approval by the competent authority, such changes should be documented and made available to the competent authority upon request. This applies equally to new package designs and to packagings in use.

Equipment used for inspection, measurement, testing and manufacturing is suitable for its purposes and is properly controlled, calibrated, used and maintained in accordance with procedures and schedules. All results from inspections, measurements and testing and all products of manufacturing should be fully documented.

The packages are correctly prepared, packed and transported. This includes all necessary maintenance and other administrative procedures, as well as appropriate measures for radiation protection.

All non‑conformances are correctly documented and reviewed, and accepted or rejected, and the competent authority is notified, as appropriate.

To provide evidence of the appropriate qualification of persons whose duties have a bearing on safety, including evidence of the required authorizations or certificates;

To provide evidence of the basis for these authorizations or certificates;

To provide documentation that can be used in reviews of the training programme to enable any necessary corrective actions to be taken.

Containment of the radioactive contents;

Control of external dose rate;

Prevention of criticality;

Prevention of damage caused by heat.

The organization performing the test should have an appropriate management system that addresses all aspects of the testing. It should cover not only the manufacture of the specimens to be tested but also all relevant activities relating to management, preparation, measuring, testing, recording, analysing (including corrective measures, if necessary) and reporting associated with the particular test or series of tests to be undertaken.

The test programme should satisfy the approving body (i.e. the competent authority or other appropriate organization). The number of tests and specimens, the test conditions, the test sequences, the measurement techniques, the methods of analysis and the acceptance criteria should be clearly established. When drop tests are included, drop sequences and drop attitudes should be agreed with the approving body. Owing to unexpected results during testing, some variation in the test programme may be necessary in the course of testing, and allowance should be made for this fact when preparing test specimens, scheduling tests and using test facilities.

The objectives and parameters of the tests should be clearly established. It should be made clear whether (i) the sole objective of the tests is a straightforward verification that the package meets all the requirements of the Transport Regulations or only some of these requirements, (ii) the designer wants different (e.g. more stringent) test criteria to be applied or (iii) additional information is being sought from the tests to improve the designer’s knowledge of the design principles, safety margins and performance.

It should be clearly established that the test facilities comply with the requirements of the Transport Regulations, particularly in the case of the targets used for drop and penetration tests, in which the weight of the test specimen is limited by the capacity of the test facility.

All measuring and monitoring equipment used before, during and after the tests to confirm and record the state of the test specimen and any forces imposed on it as a result of the tests, should be operated within the applicable national or international limits for the particular pieces of equipment. It should be verified that this equipment works accurately, within applicable national or international limits. This should be achieved by using properly calibrated measuring or test equipment, such as pressure and leak test equipment, accelerometers, strain gauges and thermal measuring apparatuses.

Adequate methods of recording the information obtained during the test programme should be implemented, and appropriate test records should be made available to the competent authority so that compliance with the requirements of the Transport Regulations can be confirmed.

All test results, including any instances of damage, should be considered as part of the competent authority’s assessment of the final package design.

The management system under which the package is designed, manufactured and transported;

The design process and the internal process to provide documentary evidence that the package design meets all applicable requirements (see para. 4.41);

Control of manufacturing;

The programme for maintenance of packagings (in the case of reusable packagings).

Containment of the radioactive contents;

Control of external dose rate;

Prevention of criticality;

Prevention of damage caused by heat.

The assessor should have a thorough knowledge of the Transport Regulations pertinent to the design under assessment to ensure that the design will produce a package that is safe under routine, normal and accident conditions of transport.

Before commencing the design assessment, the assessor should be satisfied that a management system at an appropriate level has been applied throughout the design process; appropriate evidence of this should be made available to the assessor (paras 807(c), 809(j) and 815 of the Transport Regulations). Before initiating a detailed review of an application, the completeness of the design description and specification should be confirmed, including information regarding the intended use of the package design (e.g. mode of transport, handling during transport, transport after storage).

The assessor should thoroughly examine the thermal aspects of the package design; the assessor should consider both dissipation and absorption of heat in routine, normal and accident conditions of transport. Thermal stresses should be analysed to ensure that the leaktightness or mechanical properties of the package are not unduly compromised in routine and normal conditions of transport or in thermal test conditions.

The assessor should ensure that any computer codes, methods of calculation, or models used by the applicant are appropriate and have been validated, and that all input data have been correctly — and, if appropriate, conservatively — defined.

The assessor should examine all relevant mechanical aspects of the design to confirm that the package will be physically able to safely carry the specified radioactive material under routine, normal and accident conditions of transport (this includes, for example, tie‑down points and trunnions). The assessor should analyse the structural attributes of the package and should verify that any impact or other damage the package might sustain in routine, normal or accident conditions of transport will not compromise its ability to meet the requirements of the Transport Regulations.

The assessor should examine all materials intended for use in manufacturing the package with regard to their correct specification and condition, their ability to perform satisfactorily under all expected and specified environmental conditions (e.g. temperature, pressure, irradiation, humidity) and their compatibility with other materials used.

The assessor should verify that ageing mechanisms have been taken into account.

The assessor should examine in detail the shielding features and radiation safety aspects of the design; the assessor should confirm that, with regard to the maximum proposed radioactive contents, the design of the package provides sufficient radiological shielding in all directions to comply with the Transport Regulations and the principle of optimization of protection. The assessor should confirm that any material used for shielding is physically and chemically stable and is not likely to move or to deteriorate during transport, since this would decrease the degree of shielding provided by the packaging. The absence of any radiation ‘shine paths’ through package closures and ports used for package testing should be verified.

The need to decontaminate the packagings in use should also be considered. The assessor should confirm the absence of features that might retain contamination and the absence of materials that are difficult to decontaminate.

The assessor should thoroughly examine all aspects of containment provided by the package. The assessor should also consider the features of the design that provide for containment and should determine how they might be adversely affected by routine and normal conditions of transport, by the prescribed maintenance periods and instructions, and by the effects of accident conditions of transport and related testing.

For packages designed to contain fissile material, the assessor should thoroughly examine all aspects of the package that are designed to maintain subcriticality during routine, normal and accident conditions. The assessor should specifically consider the contingencies listed in para. 673(a) and the requirements of para. 673(b) of the Transport Regulations.

The assessor should examine the in‑service handling and use, inspection, and maintenance instructions and specifications in sufficient depth to verify that all such instructions and specifications are appropriate for the package as designed. The assessor should verify that in‑service instructions and specifications provide for authorized repairs and modifications of the packaging. The procedures for repair and modification should be agreed with the assessor. The assessor should also consider that such package instructions may have to be followed by carriers and consignees that are unfamiliar with the package and its design principles.

All required markings, serial numbers and identification marks are correctly, durably and appropriately applied to packages.

The user’s scheduled inspection and maintenance programme for packagings includes provisions for inspecting and, if necessary, correcting all permanent markings and for repairing any damage or defects.

The competent authority of the State in which the design of the packaging originated;

The competent authority of the State in which the packaging was manufactured;

The competent authority of the State or States in which the packaging is used.

The user’s management should provide the necessary personnel and resources to implement an effective programme for compliance with the Transport Regulations. This programme should be part of the management system of the user. The persons responsible for fulfilling specific requirements should be clearly identified. The management system should clearly delegate authority to those responsible persons.

Suitable training should be provided for those persons responsible for implementing the programme for compliance with the Transport Regulations, and this training should be documented.

Packagings appropriate for the contents of the packages should be used.

The user should have all the documentation required by the Transport Regulations, including the relevant certificates of approval by the competent authority and any associated instructions for emergency arrangements; for handling, loading, stowage and use of packages; and for the maintenance of packagings. These instructions are usually in the form of an instruction manual.

The user should follow established procedures for the preparation and use of the packages, in accordance with the certificate of approval, the instruction manual and related documents.

Procedures should be established and followed to properly mark and label packages in accordance with the Transport Regulations. This should include the proper determination and application of the correct transport index.

Procedures should be established and followed, and appropriate and properly calibrated instruments should be provided, to monitor dose rates and contamination levels.

Procedures should be established and followed for the preparation and control of transport documents, for the placarding of vehicles, for the provision of documentation for carriers and for the notification of competent authorities.

During transport, carriers should perform the required actions for placarding and for the stowage and separation of packages in accordance with the Transport Regulations. Carriers should also undertake any administrative controls relating to exclusive use shipments or any supplementary operational controls specified in the certificate of approval of the competent authority.

Procedures should be established to respond to cases of non‑compliance in order to meet the requirements of para. 309 of the Transport Regulations.

The consignor should have an appropriate and functioning management system to cover all aspects of its responsibilities and activities in the transport of radioactive material. If a consignor consigns only one type of package infrequently, the consignor may control and conduct all activities directly. A consignor that produces or reuses a large number of different package types may use different contractors for different parts of the work, but the activities of such contractors should be provided for and controlled by means of the consignor’s management system.

The consignor should have a clear understanding of the nature, form and activity of the radioactive material to be consigned.

The consignor should fill or load the material into the packaging for transport in accordance with the package requirements and instructions. This could involve, for example, verifying that the contents of the package have been positioned correctly within the packaging to maximize the shielding protection afforded by the packaging.

The consignor should use appropriate packaging for which there is a valid certificate of approval or appropriate documentary evidence of compliance. Package design approvals should be valid for the entire duration of the journey and should not expire in the course of long international transport. Also, the certificate of approval is required to cover the entire radioactive contents permitted to be carried, and the consignor is required to have the correct certificate for the contents being transported in accordance with the Transport Regulations.

The consignor should have the relevant packing instructions for the package; copies of these instructions are required to be available at the location where the package is prepared for transport. The packing instructions provide detailed information and instructions on the loading configuration of the contents, the closure methods and the tightening torques of fasteners; to be followed by the consignor.

The consignor should ensure that the package used for transport conforms to its specifications, including those indicated on a certificate of approval for a package design that requires competent authority approval, and that the packaging is in an acceptable condition. For packagings, the consignor should have evidence, such as certificates of conformity or inspection reports, that indicate that the packagings conform to their specifications, including those indicated on a certificate of approval for a package design that requires competent authority approval. In the case of reusable packagings, the consignor should have evidence (e.g. in the form of inspection reports, release notes and certificates of conformity) that all necessary and specified maintenance work has been performed and that the packaging is suitable for the next complete transport operation or programme of movements. The consignor should not use a package that does not comply with the approved specifications or that has not been subjected to the required maintenance.

The consignor should complete and apply the correct labels and markings for packages when they are presented for transport. For example, the consignor should determine the transport index and should have correctly functioning and calibrated monitoring instruments for measuring the dose rates of the package, the overpack, the freight container and the vehicle.

The consignor should have appropriate, calibrated monitoring instruments and trained staff so that the staff can measure dose rates and radioactive contamination associated with the transport of radioactive material. For example, the consignor should be able to satisfy the competent authority that its staff is knowledgeable in the operation of the monitoring instruments and is capable of conducting correct measurements of dose rates and radioactive contamination as required by the Transport Regulations.

Subject to national legislation, the consignor should have the necessary licences or other permissions, granted by the competent authority or by other governmental bodies, to function as a consignor of radioactive material. Also, the competent authority should be satisfied that the consignor has the approvals required for the transport of the radioactive material (e.g. shipment approval, special form approval). Multiple approvals may be necessary for the transport of radioactive material where considerations of security and considerations of nuclear material accounting and control apply.

The consignor is required to complete the required transport documents, giving the appropriate information, as specified in paras 546–555 of the Transport Regulations. The consignor should also provide the transport documents to the carrier to enable the carrier, or any subsequent carriers, to meet any other applicable national or international modal regulations. The consignor is required to retain a copy of each transport document for a minimum period of three months (see para. 555 of the Transport Regulations). During inspections by the competent authority, it should be verified that complete and accurate information is given in the transport documents (sometimes called ‘shipper’s certificates’ or ‘consignment notes’). It should be verified that the transport documents take account of any variations imposed by national or international modal regulations. It should also be verified that the transport documents cover the entire journey of the consignment.

The consignor is required to provide information to the carriers, in accordance with para. 554 of the Transport Regulations. The competent authority should verify that the required information and documents have been provided to the carriers by inspecting both the consignor and the carriers (see para. 4.81).

The consignor should notify the competent authorities of transport movements, as required by paras 557–560 and summarized in annex I to the Transport Regulations. Through its inspections of consignors and its liaison with other competent authorities, the responsible competent authority should verify that the required notifications are being made.

The consignor is required, before each shipment of any package, to ensure that the requirements specified in the relevant provisions of the Transport Regulations and in the applicable certificates of approval have been fulfilled (see para. 503 of the Transport Regulations). During the lifetime of a packaging, the consignor should maintain records demonstrating that the requirements of para. 503 of the Transport Regulations have been met. The competent authority should verify that the consignor’s management system provides controls to ensure that all required pre‑dispatch activities have been specified and completed and that the declaration and signature of the final consignor are valid.

The consignor should have appropriate procedures in place to detect cases of non‑compliance and to respond in accordance with the requirements of para. 309 of the Transport Regulations.

The activities of the consignor are covered by a radiation protection programme that meets the requirements of para. 302 of the Transport Regulations. Further recommendations on radiation protection programmes are provided in paras 4.64 and 4.65 of this Safety Guide.

The carrier should have an appropriate management system that meets the requirements of para. 306 of the Transport Regulations and covers all relevant aspects of the carrier’s responsibilities and activities in the transport of radioactive material. A carrier that occasionally carries one type of package within national boundaries using one mode of transport may have a relatively simple management system. In contrast, a national or international carrier that frequently carries large numbers of packages and operates a multimodal carriage and distribution service will need a more comprehensive management system to control its activities and to ensure compliance with the Transport Regulations.

The carrier should have sufficient knowledge of national and international regulations to understand the information and documents provided by the consignor. The carrier should have knowledge and understanding of the requirements for transport documents established in paras 546–554 of the Transport Regulations and implement procedures for checking the validity and accuracy of such documents.

The carrier should have knowledge of, and the ability and resources to meet, additional provisions concerning loading, stowage, transport, handling and unloading of packages, as well as the ability to comply with any restrictions on routeing, means of conveyance or mode of transport. For conveyances such as trucks or railway wagons, the carrier should have the necessary facilities or equipment for achieving secure tie‑down arrangements and should comply with any additional speed limits that are specified. Also, if escort vehicles and personnel are required for the transport operations, the carrier should demonstrate to the competent authority that it can provide them.

The carrier should be able to identify damaged or poorly prepared packages. The carrier should be familiar with the required placards, package labels and markings, should understand their meaning and purpose, and should be able to relate the information displayed to the details given in the transport documents. The carrier should have the appropriate procedures and the necessary understanding to ensure that any damaged, poorly prepared or incorrectly labelled packages are rejected or quarantined, that packages are correctly stowed within the vehicle and that basic checks of the transport documents against the package labels will be conducted.

The carrier should operate vehicles or other means of conveyance that can be used to carry the radioactive material or packages safely, without overloading, without infringing the required segregation distances and without exceeding the limitations on the transport index and the criticality safety index. The carrier should ensure that, when required, the number, type, size and location of placards on the conveyance meet the regulatory requirements.

The carrier is required to establish appropriate arrangements for a nuclear or radiological emergency (see paras 304 and 305 of the Transport Regulations). These arrangements should take account of the types of radioactive material being carried and the type of conveyance being used. The carrier may have its own emergency arrangements; alternatively, the carrier may participate in or use the consignor’s emergency arrangements or other national emergency schemes or arrangements. Irrespective of the emergency arrangements that apply, the carrier should be familiar with the arrangements in place, and all personnel involved should receive the necessary training in the emergency arrangements.

The carrier should have the capability to implement appropriate controls in connection with storage in transit, in particular with regard to the safety of workers and the public. The carrier is required to implement the provisions established in paras 562 and 563 of the Transport Regulations concerning the segregation of packages during transport and storage in transit.

The carrier should have appropriate procedures in place to identify cases of non‑compliance and to take appropriate action in accordance with the requirements of para. 309 of the Transport Regulations.

The activities of the carrier are covered by a radiation protection programme that meets the requirements of para. 302 of the Transport Regulations. Further recommendations on radiation protection programmes are provided in paras 4.64 and 4.65 of this Safety Guide.

The consignee should have a management system that meets the requirements of para. 306 of the Transport Regulations and that covers all applicable activities.

A radiation protection programme that meets the requirements of para. 302 of the Transport Regulations should be established and implemented. Further recommendations on radiation protection programmes are provided in paras 4.64 and 4.65 of this Safety Guide.

Workers of the consignee should receive appropriate training commensurate with their duties.

The consignee should be able to take appropriate actions in cases of non‑compliance, in accordance with the requirements of para. 309 of the Transport Regulations.

Independent approval by the responsible competent authority of each country through or into which the consignment is to be transported (i.e. a chain of multilateral competent authority approvals);

Validation of the original certificate issued by the competent authority of the country of origin of the design or shipment in accordance with para. 840 of the Transport Regulations.

INTERNATIONAL ATOMIC ENERGY AGENCY, Regulations for the Safe Transport of Radioactive Material, 2018 Edition, IAEA Safety Standards Series No. SSR-6 (Rev. 1), IAEA, Vienna (2018).

INTERNATIONAL ATOMIC ENERGY AGENCY, Advisory Material for the IAEA Regulations for the Safe Transport of Radioactive Material (2018 Edition), IAEA Safety Standards Series No. SSR-26 (Rev. 1), IAEA, Vienna (2022).

INTERNATIONAL ATOMIC ENERGY AGENCY, Organization, Management and Staffing of the Regulatory Body for Safety, IAEA Safety Standards Series No. GSG-12, IAEA, Vienna (2018).

INTERNATIONAL ATOMIC ENERGY AGENCY, Functions and Processes of the Regulatory Body for Safety, IAEA Safety Standards Series No. GSG-13, IAEA, Vienna (2018).

INTERNATIONAL ATOMIC ENERGY AGENCY, Leadership and Management for Safety, IAEA Safety Standards Series No. GSR Part 2, IAEA, Vienna (2016).

INTERNATIONAL ATOMIC ENERGY AGENCY, Governmental, Legal and Regulatory Framework for Safety, IAEA Safety Standards Series No. GSR Part 1 (Rev. 1), IAEA, Vienna (2016).

INTERNATIONAL ATOMIC ENERGY AGENCY, Establishing the Infrastructure for Radiation Safety, IAEA Safety Standards Series No. SSG-44, IAEA, Vienna (2018).

INTERNATIONAL ATOMIC ENERGY AGENCY, IAEA Nuclear Safety and Security Glossary: Terminology Used in Nuclear Safety, Nuclear Security, Radiation Protection and Emergency Preparedness and Response, 2022 (Interim) Edition, IAEA, Vienna (2022).

INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL CIVIL AVIATION ORGANIZATION, INTERNATIONAL MARITIME ORGANIZATION, Preparedness and Response for a Nuclear or Radiological Emergency Involving the Transport of Radioactive Material, IAEA Safety Standards Series No. SSG-65, IAEA, Vienna (2022).

The Convention on the Physical Protection of Nuclear Material, INFCIRC/274/Rev. 1, IAEA, Vienna (1980).

Amendment to the Convention on the Physical Protection of Nuclear Material, INFCIRC/274/Rev. 1/Mod. 1, IAEA, Vienna (2016).

UNITED NATIONS, Recommendations on the Transport of Dangerous Goods, Model Regulations, ST/SG/AC.10/1/Rev.22, 2 vols, United Nations, New York and Geneva (2019).

INTERNATIONAL CIVIL AVIATION ORGANIZATION, Technical Instructions for the Safe Transport of Dangerous Goods by Air, 2021–2022 Edition, ICAO, Montreal (2020).

INTERNATIONAL MARITIME ORGANIZATION, International Maritime Dangerous Goods Code (IMDG Code), Amendment 40-20, 2020 Edition, IMO, London (2020).

INTERNATIONAL ATOMIC ENERGY AGENCY, Nuclear Security Recommendations on Physical Protection of Nuclear Material and Nuclear Facilities (INFCIRC/225/ Revision 5), IAEA Nuclear Security Series No. 13, IAEA, Vienna (2011).

INTERNATIONAL ATOMIC ENERGY AGENCY, Nuclear Security Recommendations on Radioactive Material and Associated Facilities, IAEA Nuclear Security Series No. 14, IAEA, Vienna (2011).

INTERNATIONAL ATOMIC ENERGY AGENCY, Security of Nuclear Material in Transport, IAEA Nuclear Security Series No. 26-G, IAEA, Vienna (2015).

INTERNATIONAL ATOMIC ENERGY AGENCY, Security of Radioactive Material in Transport, IAEA Nuclear Security Series No. 9-G (Rev. 1), IAEA, Vienna (2020).

INTERNATIONAL CIVIL AVIATION ORGANIZATION, Convention on International Civil Aviation (Chicago Convention), Doc 7300/9, Ninth Edition, ICAO, Montreal (2006).

INTERNATIONAL MARITIME ORGANIZATION, International Convention for the Safety of Life at Sea (SOLAS), 1974, as amended, IMO, London (1974).

UNIVERSAL POSTAL UNION, Convention Manual, Update 2 — October 2020, UPU, Berne (2020).

UNITED NATIONS ECONOMIC COMMISSION FOR EUROPE, INLAND TRANSPORT COMMITTEE, Agreement Concerning the International Carriage of Dangerous Goods by Road, UNECE, New York and Geneva (2020).

INTERGOVERNMENTAL ORGANISATION FOR INTERNATIONAL CARRIAGE BY RAIL, Convention Concerning International Carriage by Rail, OTIF, Berne (1999).

INTERGOVERNMENTAL ORGANISATION FOR INTERNATIONAL CARRIAGE BY RAIL, Regulations concerning the International Carriage of Dangerous Goods by Rail, 2021 Edition, OTIF, Berne (2020).

UNITED NATIONS ECONOMIC COMMISSION FOR EUROPE, COMMITTEE ON INLAND TRANSPORT, European Agreement Concerning the International Carriage of Dangerous Goods by Inland Waterways, UNECE, New York and Geneva (2020).

The MERCOSUR/MERCOSUL Agreement of Partial Reach to Facilitate the Transport of Dangerous Goods (1994).

ORGANIZATION FOR COOPERATION OF RAILWAYS, Agreement on International Goods Traffic by Rail, Warsaw (1951).

INTERNATIONAL ATOMIC ENERGY AGENCY, The Management System for the Safe Transport of Radioactive Material, IAEA Safety Standards Series No. TS-G-1.4, IAEA, Vienna (2008).

INTERNATIONAL ATOMIC ENERGY AGENCY, Safe Transport of Radioactive Material, Fourth Edition, Training Course Series No. 1, IAEA, Vienna (2006).

INTERNATIONAL ATOMIC ENERGY AGENCY, Communication and Consultation with Interested Parties by the Regulatory Body, IAEA Safety Standards Series No. GSG‑6, IAEA, Vienna (2017).

INTERNATIONAL ATOMIC ENERGY AGENCY, Format and Content of the Package Design Safety Report for the Transport of Radioactive Material, IAEA Safety Standards Series No. SSG-66, IAEA, Vienna (2022).

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, Series 1 Freight Containers — Specification and Testing — Part 1: General Cargo Containers for General Purposes, ISO 1496 1:1990, ISO, Geneva (1990); Amendments 1:1993, 2:1998, 3:2005, 4:2006, 5:2006 and ISO 1496 1:2013.

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FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS, INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL CIVIL AVIATION ORGANIZATION, INTERNATIONAL LABOUR ORGANIZATION, INTERNATIONAL MARITIME ORGANIZATION, INTERPOL, OECD NUCLEAR ENERGY AGENCY, PAN AMERICAN HEALTH ORGANIZATION, PREPARATORY COMMISSION FOR THE COMPREHENSIVE NUCLEAR TEST BAN TREATY ORGANIZATION, UNITED NATIONS ENVIRONMENT PROGRAMME, UNITED NATIONS OFFICE FOR THE COORDINATION OF HUMANITARIAN AFFAIRS, WORLD HEALTH ORGANIZATION, WORLD METEOROLOGICAL ORGANIZATION, Preparedness and Response for a Nuclear or Radiological Emergency, IAEA Safety Standards Series No. GSR Part 7, IAEA, Vienna (2015).

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INTERNATIONAL ATOMIC ENERGY AGENCY, Schedules of Provisions of the IAEA Regulations for the Safe Transport of Radioactive Material (2018 Edition), IAEA Safety Standards Series No. SSG-33 (Rev. 1), IAEA, Vienna (2021).

Design of packages;

Design of special form radioactive material and low dispersible radioactive material;

Shipments;

Shipments under special arrangement;

Management systems.

General information:

Administrative information, including the following:

Specific information as required by para. 803 of the Transport Regulations. A detailed description of the radioactive material or, if a capsule, the contents, including the following:

A detailed statement of the design of any capsule to be used.

A statement of the tests that have been performed and their results, or evidence based on calculations, to show that the radioactive material is capable of meeting the performance standards, or other evidence that the special form radioactive material or low dispersible radioactive material meets the applicable requirements of the Transport Regulations.

A specification of the applicable management system, as required by para. 306 of the Transport Regulations.

Any proposed pre‑shipment actions for use in the consignment of special form radioactive material or low dispersible radioactive material.

General description of the design and of the intended use of the special form or low dispersible radioactive material.

List of applicable national and international regulations and the edition of the Transport Regulations under which competent authority approval is sought.

Name, address, telephone number and email address of the applicant;

Name, address, telephone number and email address of the designer;

Type of approval required (i.e. special form or low dispersible radioactive material);

Identification mark of the competent authority, if previously allocated;

General arrangement drawing number;

Date of application;

Date by which approval is desired.

Radionuclides present;

Total activity;

Nature of emitted radiation;

Heat output;

Physical and chemical state;

Overall dimension and mass.

General information:

Administrative information, including the following:

Specific information for shipments described in para. 825(a)–(c) and (e) of the Transport Regulations, as required by para. 827 of the Transport Regulations, including the following:

Additional specific information for SCO‑III shipments, as required by para. 827A of the Transport Regulations:

General description of the shipment from consignor to consignee, including loading, carriage and unloading of the consignment; stowage arrangements; storage in transit; and provisions for exclusive use, if applicable.

Number of shipments.

List of applicable national and international regulations and the edition of the Transport Regulations under which competent authority approval is sought.

Specification of the applicable management system, radiation protection programme and emergency procedure.

Radiation protection programme for shipments by special use vessels, in accordance with para. 576(a) of the Transport Regulations.

Applicable package design certificates of approval (i.e. Type B(M) packages or packages containing fissile material).

Name, address, telephone number and email address of the applicant;

Name, address, telephone number and email address of the consignor;

Name, address, telephone number and email address of the consignee;

Name, address, telephone number and email address of the carrier;

Type of shipment approval required, as specified in para. 825 of the Transport Regulations;

Identification mark of the competent authority, if previously allocated;

Date of application;

Date by which approval is desired.

The period of time, related to the shipment, for which the approval is sought.

The actual radioactive contents, including the following:

The modes of transport.

The type of conveyance and the probable or proposed route.

The details of how the precautions and administrative or operational controls, referred to in the certificates of approval for the package design, if applicable, issued under paras 810, 813 and 816 of the Transport Regulations, are to be put into effect.

Radionuclides present;

Total activity;

Nature of emitted radiation;

Heat output;

Physical and chemical state;

Quantity in mass units; for packages containing fissile material, the quantity of fissile material or fissile nuclides in mass units and the enrichment in percentage; for irradiated fuel, the burnup, irradiation time, cooling time and initial enrichment.

A statement of the respects in which, and the reasons why, the consignment is considered SCO‑III (surface contaminated object of the group SCO‑III).

Justification for choosing SCO‑III by demonstrating the following:

A detailed description of the proposed radioactive contents with reference to their physical and chemical states and the nature of the radiation emitted.

A detailed statement of the design of the SCO‑III, including complete engineering drawings and schedules of materials and methods of manufacture.

All information necessary to satisfy the competent authority that the requirements of paras 520(e) and 522 of the Transport Regulations, if applicable, are satisfied.

A transport plan that describes various aspects of the shipment, as required by para. 520(e)(iii) of the Transport Regulations.

A specification of the applicable management system, as required in para. 306 of the Transport Regulations.

No suitable packaging currently exists.

Designing or constructing a packaging or segmenting the object is not practically, technically or economically feasible.

No other viable alternative exists.

General information:

Administrative information, including the following:

Specific information as required by para. 830 of the Transport Regulations. Paragraph 830 of the Transport Regulations states:

“An application for approval of shipments under special arrangement needs to include all the information necessary to satisfy the competent authority that the overall level of safety in transport is at least equivalent to that which would be provided if all the applicable requirements of these Regulations had been met. The application shall also include:

(a) A statement of the respects in which, and of the reasons why, the shipment cannot be made in full accordance with the applicable requirements;

(b) A statement of any special precautions or special administrative or operational controls that are to be employed during transport to compensate for the failure to meet the applicable requirements.”

General description of the shipment from consignor to consignee, including loading, carriage and unloading of the consignment; stowage arrangements; storage in transit; and provisions for exclusive use, if applicable.

Number of shipments.

List of applicable national and international regulations and the edition of the Transport Regulations under which competent authority approval is sought.

Specification of the applicable management system, radiation protection programme and emergency procedure.

Name, address, telephone number and email address of the applicant;

Name, address, telephone number and email address of the consignor;

Name, address, telephone number and email address of the consignee;

Name, address, telephone number and email address of the carrier;

Identification mark of the competent authority, if previously allocated;

Date of application;

Date by which approval is desired.

Management system organization:

Management system programme:

Package design control: A description of the measures implemented to ensure the following:

Procurement document control: A description of the measures implemented to control the preparation, review, concurrence and approval of all procurement documents.

Instructions, procedures and drawings: A description of the measures implemented to ensure the following:

Document control:

Control of purchased material, equipment and services: A description of the measures implemented to ensure that materials, equipment and services conform to procurement documents.

Identification and control of materials, parts and components: A description of the measures implemented to ensure that materials, parts and components, including partially fabricated assemblies, are adequately identified to preclude the use of incorrect or defective items.

Control of special processes¹: A description of the measures implemented to ensure that special processes are controlled to ensure the following:

Internal inspection: A description of the measures established to ensure that the following activities concerning internal inspections are implemented:

Test control: A description of the measures established to ensure that applicable test programmes, including prototype qualification tests, production tests, proof tests and operational tests, are accomplished in accordance with written procedures. This includes measures established to ensure that modifications, repairs and replacements are tested in accordance with the original design and testing requirements.

Control of measuring and test equipment: A description of the measures established to ensure that measurement and test equipment (e.g. gauges, fixtures, reference standards, devices used to measure product characteristics) is calibrated, adjusted and maintained at prescribed intervals or prior to use.

Handling, storage and shipping control: A description of the measures established to ensure that cleaning, handling, storage and shipping are accomplished in accordance with design requirements to preclude damage or deterioration by environmental conditions such as temperature and humidity.

Inspection, test and operating status: A description of the measures established to ensure that the status of inspections, tests and operating conditions (including maintenance of items) is known by organizations responsible for ensuring quality.

Non‑conforming materials, parts or components: A description of the measures established for controlling non‑conforming items, including the following principal elements:

Corrective actions: A description of the measures established to ensure that the causes of conditions detrimental to quality (e.g. those resulting from failures, malfunctions, deficiencies, deviations, or defective material and equipment) are promptly identified and reported to appropriate levels of management. Also, a description of the measures established to obtain corrective actions from suppliers and ensure that follow‑up actions are documented to verify that the corrective actions were implemented and effective.

Management system records: A description of the measures established to ensure that management system records provide documentary evidence of the activities that affect quality and provide sufficient information to allow each record to be identified with the items or activities to which it applies. At a minimum, management system records might include the following information:

Audits: A description of the measures implemented to ensure that internal audits are performed that address the following elements:

Documentation of the formal structure of the organization by organization charts that identify each organizational element that functions under the management system.

Documentation of the commitment of top management, stating that it is the policy of the organization to perform work on items important to transport safety in accordance with the management system.

Scope of the management system: a description of the measures established for identifying the following: — The structures, systems and components covered by the management system; — The approach to verifying that the applicable structures, systems and components meet the objectives of the management system.

A description of the measures implemented to ensure the following:

Activities important to safety are performed using specific instructions and specified equipment and under suitable environmental conditions.

Management system manuals specify the designated responsibilities for implementation of activities important to safety.

The user of the management system has established induction and training programmes to ensure that personnel performing activities important to safety are trained and qualified to perform those activities.

Cooperation among those responsible for preparing design documentation;

Appropriate design analyses, including independent design verification;

Coordinating interfaces between involved personnel;

Maintenance of lines of communication during the design process.

Activities important to safety are prescribed and accomplished in accordance with current documented instructions, procedures or drawings, which have been approved by appropriate levels of management.

All work activities are coordinated with management system personnel to ensure that the work controlling documents incorporate appropriate inspection and hold points to verify that initial work, planned work, effective repairs or rework have been performed satisfactorily.

Instructions, procedures and drawings include quantitative acceptance criteria (e.g. dimensions, tolerances, operating and regulatory limits) and qualitative acceptance criteria (e.g. workmanship samples) to verify that activities important to safety have been satisfactorily accomplished.

Written procedures address the use, management, storage and protection of electronic records and data.

Information is maintained on the specific software applications and storage or computing hardware.

A description of the measures implemented to ensure that each of the documents under the control of the management system reflects its current status.

A description of controls established to ensure that all documents and changes thereto are adequately reviewed and approved prior to their issuance.

Procedures, equipment and personnel are qualified in accordance with applicable codes, standards and specifications.

The operations are performed by qualified personnel and accomplished in accordance with written process or procedure sheets that direct the recording of evidence of verification.

Qualification records of procedures, equipment and personnel are established, filed and kept current.

Inspection procedures, instructions or checklists are available for each work operation, where necessary to ensure quality.

Documents developed include methods for identifying characteristics and activities to be inspected, acceptance and rejection criteria, and the individuals or groups responsible for performing the inspection.

Objective evidence of inspection results is recorded. (iv) Hold or witness points are identified.

The appropriate personnel approve data to ensure that all inspection requirements have been satisfied.

The prerequisites to be satisfied prior to inspection are identified, including operator qualification and equipment calibration. Where sampling is used to verify acceptability of a group of items, the standard used as the basis for acceptance needs to be identified.

Inspectors are qualified in accordance with applicable codes, standards and training programmes.

Appropriate inspections are performed during various phases of operation, such as receiving inspections, in‑process inspections, final inspections and maintenance inspections.

Proper identification;

Segregation of discrepant or non‑conforming items;

Disposition of the non‑conforming items;

Evaluation of the non‑conforming items.

Design, procurement, manufacturing and installation records;

Supplier evaluations;

Non‑conformance reports;

Results of inspections and tests;

Failure analyses;

As‑built drawings and specifications;

Qualification of personnel, procedures and equipment;

Calibration procedures;

Training and retraining records;

Corrective action reports;

Records demonstrating evidence of operational capability;

Records verifying repair, rework and replacement;

Audit plans, audit reports and corrective actions;

Records that are used as a baseline for maintenance.

Assurance of authority and organizational independence of the auditors;

A commitment to adequate staffing levels, funding and facilities to implement the audit;

Identification of audit personnel and their qualifications;

Provisions for reasonable and timely access of audit personnel to facilities and documents and to the qualified personnel necessary for performing audits;

Use of established procedures and checklists;

Methods for reporting audit findings to the responsible management of both the audited and auditing organizations;

Provisions for the audit team to gain access to levels of management that have responsibility and authority for corrective action;

Methods for verifying that effective corrective action has been accomplished on a timely basis.

Design of packages;

Design of special form radioactive material and low dispersible radioactive material;

Shipments;

Shipments under special arrangement.

Reproducible illustration not larger than 21 cm × 30 cm showing the make‑up of the package.

Packaging:

Radioactive contents (non‑fissile):

For designs of packages containing fissile material that require multilateral approval of the package design in accordance with para. 814 of SSR‑6 (Rev. 1):

Model name or number;

Description (e.g. use, dimensions, materials of manufacture, closures, penetrations, gross mass);

Reference to drawings or specification of design;

Description of the containment system.

Radioisotopes;

Physical and chemical form (including special form radioactive material or low dispersible radioactive material, if applicable) and the mass in grams;

Maximum activity per package (including activities of the various isotopes);

Any restrictions on the radioactive contents that might not be obvious from the nature of the packaging.

Type and form of fissile material;

The maximum total mass of fissile nuclides or the mass for each fissile nuclide, when appropriate;

Description of the confinement system;

Criticality safety index;

Reference to the documentation that demonstrates the criticality safety of the package;

Special features on the basis of which the absence of water from certain void spaces has been assumed in the criticality assessment;

Any allowance (based on para. 677(b) of SSR‑6 (Rev. 1)) for a change in neutron multiplication assumed in the criticality assessment as a result of actual irradiation experience;

The ambient temperature for which the package design has been approved.

Road:

Rail:

Sea:

Inland waterways:

Air:

International:

Other:

Road:

Rail:

Sea:

Inland waterways:

Air:

International:

Other:

Radioisotopes (including fissile material);

Physical and chemical form (e.g. special form radioactive material, low dispersible radioactive material, or fissile material excepted under para. 417(f) of SSR‑6 (Rev. 1), if applicable);

Total activity per package and per conveyance (including activities of the various isotopes, if appropriate) and total mass in grams per package and conveyance;

Total amount in grams of fissile material (or for each fissile nuclide, when appropriate) per package and per conveyance;

Any restrictions on the radioactive contents that might not be obvious from the nature of the packaging.

Road:

Rail:

Sea:

Inland waterways:

Air:

International:

Other:

Reproducible illustration not larger than 21 cm × 30 cm showing the make‑up of the package.

Packaging:

Radioactive contents (non‑fissile):

Additionally, for packages containing fissile material:

Model name or number;

Description (e.g. use, dimensions, materials of manufacture, closures, penetrations, gross mass);

Reference to drawings or a specification of the design;

Description of the containment system.

Radioisotopes;

Physical and chemical form (including special form radioactive material, low dispersible radioactive material, or fissile material excepted under para. 417(f) of SSR‑6 (Rev. 1), if applicable);

Maximum activity per package (including activities of the various isotopes, if appropriate) and total mass in grams per package;

Any restrictions on the radioactive contents that might not be obvious from the nature of the packaging.

Type and form of fissile material;

The maximum total mass of fissile nuclides or the mass for each fissile nuclide, when appropriate;

Description of the confinement system;

Criticality safety index;

Reference to the documentation that demonstrates the criticality safety of the package;

Special features on the basis of which the absence of water from certain void spaces has been assumed in the criticality assessment;

Any allowance (based on para. 677(b) of SSR‑6 (Rev. 1)) for a change in neutron multiplication assumed in the criticality assessment as a result of actual irradiation experience;

The ambient temperature for which the special arrangement has been approved.

Road:

Rail:

Sea:

Inland waterways:

Air:

International:

Other:

The management of the organization has provided the necessary personnel and resources to implement an effective programme for compliance with IAEA Safety Standards Series No. SSR‑6 (Rev. 1), Regulations for the Safe Transport of Radioactive Material, 2018 Edition [III–1] (hereinafter the ‘Transport Regulations’). This programme needs to clearly identify the persons responsible for fulfilling the various specific requirements. There needs to be a clear delegation of authority by management to those responsible persons.

The management has provided proper training to the persons responsible for implementing the programme for compliance with the Transport Regulations. Documentation of the training that has been provided needs to be submitted to the competent authority upon request.

Established procedures are followed for the design and fabrication or the selection and procurement of packagings.

The consignor is using the proper packaging for the specific contents of packages. The competent authority may perform direct examination of packages being prepared for shipment.

The organization has in its possession all the required documentation in accordance with the Transport Regulations, including the relevant competent authority certificates and any associated instructions for handling, loading, storage, use and maintenance of the packaging (often given in the form of an instruction manual for the packaging).

Established procedures are followed for the preparation and use of the package, in accordance with the certificate of approval, the instruction manual and related documents.

Established procedures are followed for the proper marking and labelling of packages, in accordance with the Transport Regulations. This includes the proper determination and application of the correct transport index. When practicable, the competent authority may directly observe such actions.

Established procedures are followed, and appropriate and properly calibrated instruments are provided, to monitor packages for both radiation and contamination.

Established procedures are followed for the correct preparation and control of all relevant shipping documents and for providing (i) correct placarding of the carrier’s vehicles, (ii) all the required documentation to carriers, and (iii) any required notification to the competent authorities of each country into which or through which the consignment is transported.

During transport, carriers perform any required actions relating to placarding, stowage and segregation of packages, particularly any administrative controls relating to exclusive use shipments, or supplementary operational controls as specified in the competent authority certificate.

The organization has established an appropriate radiation protection programme for its activities concerning the transport of radioactive material, and the programme is maintained, reviewed and complied with.

Procedures have been developed and implemented to respond to cases of non‑compliance, appropriate investigative and corrective actions have been taken, and the necessary reporting and communicative action is being achieved.

The organization has developed and continues to maintain appropriate emergency arrangements and conducts exercises for emergency preparedness and response periodically, as appropriate.

Purpose

Scope

Definitions

Responsibilities

Procedure

Records

Declaration

Establishing whether the elements within the management system are properly documented;

Verifying through reviews and evaluation of documentary evidence that the management system is being adequately implemented;

Evaluating the adequacy, effectiveness and efficiency of the management system;

Identifying non‑compliance, and requesting and verifying corrective actions.

The inspection plan;

Checklists;

The inspection matrix;

The inspection report;

A statement of completion of the inspection.

The date and time of the planned inspection;

Details of the inspection plan;

The name(s) of the inspector(s);

The agenda for the opening meeting.

Introduction;

The purpose of the inspection;

The inspection plan and the scope of the inspection;

The interests of other government departments;

The closing meeting.

Inspection programmes;

Individual inspection files, containing inspection plans, inspection matrices, inspection reports, follow‑up letters, correspondence and statements of completion of the inspection;

Index of completed inspections.

Is there an established and appropriately documented management system?

Is the organization’s policy and statement of authority with respect to the management system documented?

Does the management system fully identify those processes and activities covered by the management system and provide for their effective control?

Is involvement in and commitment to the management system and its objectives evident on the part of senior management?

Does the management system fully cover the activities undertaken by the organization? (These activities might include the design, manufacture, maintenance and repair of packagings, and the preparation, consigning, loading, carriage (including in‑transit storage), shipment after storage, unloading and receipt at the final destination of loads of radioactive material and packages.)

Is there a defined organizational structure, and are the management responsibilities consistent with the size and complexity of the organization and its functions?

Are the functional responsibilities and levels of authority clearly defined at all levels within the organization?

How does the organization manage organizational changes to ensure that it remains effective and that quality and compliance remain unaffected?

Are the provisions of the management system commensurate with the complexity of the packaging or its components and with the degree of hazard associated with the material being transported (i.e. a graded approach)?

Is the management system subject to review and evaluation? If so, how frequently?

Who is responsible for reviewing the management system?

Does the management system review process provide for an appropriate scope and include all necessary inputs?

Does the review process include a confirmation that the management system demonstrates compliance with IAEA Safety Standards Series No. SSR‑6 (Rev. 1), Regulations for the Safe Transport of Radioactive Material, 2018 Edition [V–1] (hereinafter the ‘Transport Regulations’) relating to the transport of radioactive material by the modes of transport used by the organization?

Does a radiation protection programme exist within the organization?

What processes are used to encourage and manage a safety culture within the organization?

Do the strategic plans of the organization include the development of its policies, objectives and processes?

DOCUMENTATION AND CONTROL OF RECORDS

Has the management system documentation been sufficiently well defined and are all essential documents supporting the effective and efficient operation of the management system in place?

Are there documented procedures to control all necessary documentation and records?

Do the procedures cover the preparation, approval and issuing of such documentation?

Has a system for the release, distribution and withdrawal of documents been established?

How are personnel made aware of changes to documents?

How are suppliers made aware of changes to documents?

Are applicable codes, standards and regulations updated as amendments are issued?

How are essential personnel made aware that amendments to documents, including codes and standards, have been issued?

Are copies of redundant or out of date documents suitably marked, withdrawn or destroyed?

Are superseded or redundant documents retained? If so, how are they controlled to prevent their accidental use?

Are changes to documents subject to review and approval:

(a) In accordance with documented procedures?

(b) By designated persons or organizations having relevant background information and knowledge and understanding of the original document?

How are incoming and/or external documents controlled?

Are records of changes to documentation retained?

Does the system cover the maintenance of essential records of the management system?

Does the system cover the identification, collection, indexing, filing, storage, maintenance and disposal of records?

Are records readily retrievable and maintained in a suitable environment?

Are retention periods for records defined?

Are records or logbooks available for each package and packaging?

Do logbooks contain the necessary information, such as movement or transport records, authorized modifications to the package, and operating and maintenance instructions?

Are records available for maintenance performed at other locations?

MANAGEMENT RESPONSIBILITY

Has a management representative been appointed and given appropriate authority to manage, monitor, evaluate and coordinate the management system?

Are measurable objectives of the management system established for relevant functions and at relevant levels within the organization?

SATISFACTION OF INTERESTED PARTIES

Are the interested parties clearly identified?

Are the needs and expectations of interested parties identified?

What processes exist within the organization to monitor and measure the satisfaction of interested parties?

RESOURCE MANAGEMENT

Is there a commitment to the timely identification and provision of necessary resources, including personnel, to meet the needs of the organization and regulatory requirements?

Are the following items described in processes and/or procedures?

(a) Human resources;

(b) Infrastructure and working environment;

(c) Financial resources;

(d) Involvement of individuals;

(e) Management of information and knowledge.

TRAINING

How does the organization encourage the involvement and development of its personnel?

How is this measured?

Does the organization provide an appropriate training programme for all personnel involved in the transport of radioactive material?

How are training needs identified?

How are training records maintained?

INFORMATION AND KNOWLEDGE MANAGEMENT

How does the organization characterize, monitor and manage information and knowledge?

Is the procedure for information and knowledge management appropriate for the organization’s transport related activities, and is it being followed?

COMMUNICATION AND INTERFACES

Does the organization provide for the effective communication of its policies, the needs of its customers and its regulatory needs to all personnel within the organization?

Are internal and external lines of communication established and defined in processes and procedures?

Are interfaces between relevant organizations established?

(a) Are the interfaces between organizations, including the responsibilities of each organization, clearly defined in processes and procedures?

(b) Are these interfaces regularly reviewed?

DEVELOPMENT OF PROCESSES

Is there evidence that the organization has developed the management and work processes associated with the transport activities of the organization (e.g. design and manufacture, maintenance and repair, assembly and disassembly, loading, handling, labelling, dispatch, carriage, receipt, unloading, and storage of packages and packagings, as appropriate)?

PROCESS MANAGEMENT AND CONTROL OF PRODUCT

Are common processes such as document control, non‑conformance control and corrective actions, management review, and internal audits identified and adopted throughout the organization?

DESIGN CONTROL

Are sufficient measures in place to control the design process, and are they described in processes and procedures?

Have appropriate responsibilities been assigned for the whole design process?

Have suitable procedures been established for communicating design information, including changes, between the following?

(a) Design disciplines;

(b) Different units within the same organization;

(c) External interfaces, including manufacturing and maintenance and repair facilities.

Is a graded approach to design used? If so, is each grade defined? For example:

(a) Grade 1:

(i) Are the relevant regulations, industrial standards and codes defined?

(ii) Does the management system dictate that design verification is to be accomplished by:

— Formal design review or prototype testing;

— Calculations; or

— Computer codes?

(b) Grade 2:

(i) Are the relevant regulations and industrial standards and codes defined?

(ii) Does the management system dictate that design verification is to be accomplished by:

— Calculations; or

— Computer codes?

(c) Grade 3: Does the design follow accepted engineering or industrial practice?

Have provisions been made to ensure that all necessary design input — including customers’ needs — has been identified and included in the design process?

Is the design input documented in a way that permits adequate evaluation by technical personnel other than those persons performing the original design?

(a) Are such evaluations planned?

(b) Are such evaluations documented?

(c) Are such evaluations performed before submitting design information to the competent authority and to suppliers, or before commencing manufacture?

Have all acceptance and verification criteria been identified in design output and included in design input?

Is design output sufficiently defined to demonstrate its conformance with design input specifications?

What measures are established for the selection of, and for the review of the suitability of, materials, equipment and processes?

(a) Are such measures defined in procedures or instructions?

(b) Are such selections and reviews documented?

(c) Are such selections and reviews evaluated by technical personnel other than those performing the original design work?

Are there suitable arrangements for review of the design output to confirm the adequacy of the design?

(a) Are design reviews conducted?

(b) Are they planned and systematic?

(c) Are they documented?

(d) Do they include technical personnel other than those persons performing the design work?

(e) Are alternative calculational methods employed?

Are there appropriate arrangements for verification and subsequent validation of the adequacy of the design, such as a programme of model, prototype or full scale testing in accordance with the requirements of the Transport Regulations?

Do the design procedures provide for the control of changes, deviations and concessions regarding the design specifications?

(a) Are changes, deviations and concessions documented?

(b) Do such documents need authorization by the person responsible for the design?

(c) Do such documents, after authorization, state the justification for acceptance of such changes, deviations and concessions?

(d) Are suitable records retained?

Are design related changes to existing and in‑service equipment covered by appropriate process controls?

(a) Is there a procedure for controlling in‑service changes or modifications?

(b) Are such in‑service changes or modifications documented?

(c) Are in‑service changes or modifications subject to the approval of the person responsible for the design?

(d) Are the justifications for accepting in‑service changes and modifications and the necessary actions documented?

(e) Is information concerning changes sent to:

(i) All affected persons and organizations?

(ii) All personnel or organizations holding the original design?

(f) Are suitable records retained?

MANAGEMENT SYSTEMS AND THE DIFFERENT PHASES OF TRANSPORT

Does the management system clearly identify the different phases of transport applicable to the organization — namely, design and manufacture, maintenance and repair, assembly and disassembly, loading, handling, labelling, dispatch, carriage, receipt, and unloading and storage of packages and/or packagings — and the interfaces between them?

PURCHASING

Have effective and efficient purchasing processes been described in procedures and suitable controls implemented?

Do the purchasing processes and procedures provide for all necessary purchase criteria to be identified and specified on purchase orders and documents?

Do the purchasing processes and procedures ensure that the relevant design documents and regulatory requirements are included or referenced in procurement documents?

Are purchasing arrangements commensurate with the importance or safety related aspects of the product being procured? Is a graded approach to products and suppliers being taken?

Do the procurement documents specify that design and quality specifications be passed on to subsuppliers?

Do the procurement documents specify that material traceability be maintained throughout fabrication and assembly, as necessary?

Are suppliers selected and evaluated for their ability to supply products in accordance with specific criteria? Who conducts this evaluation, and is it recorded?

How is the past performance of suppliers recorded?

How often is a supplier assessed?

Are audits of supplier management systems conducted as part of the evaluation process?

Are supplier audits planned and documented?

Do purchasing documents provide for adequate access by the purchaser and the competent authority to the plants of the suppliers and subsuppliers?

What controls are established to ensure that purchased items conform to the specifications of procurement documents? Are such controls documented?

Are suitable arrangements provided for the care and control of customer supplied materials or items?

IDENTIFICATION, TRACEABILITY AND PRESERVATION OF MATERIALS

Are suitable arrangements in place to determine when identification and traceability of materials, items and software are necessary?

Are the necessary identification and traceability of such items being achieved?

Are measures established to control the handling, storage and shipping of materials both at initial delivery and during use in transport operations?

Are suitable provisions in place for the preservation and protection of products, materials and packagings to ensure their fitness for use when needed?

PROCESS CONTROL

Have all relevant processes, including those necessary for the management system (e.g. design, procurement, manufacturing, delivery processes, transport operations), been identified and their control provided for?

Do process control arrangements, including procedures, instructions and drawings, include appropriate qualitative and quantitative acceptance criteria for determining that important activities have been satisfactorily accomplished?

Are documents such as quality plans produced to support process control? Are such plans available?

Are any design, production or other processes performed by subsuppliers controlled, and how is this done?

How are process control arrangements and procedures reviewed, controlled and issued?

Do subsuppliers use their own process control procedures (e.g. process procedures, work instructions) or those of the purchasing organization?

Are inspections or other process control checks performed at defined points during the process (e.g. manufacturing, maintenance)?

Are special processes (e.g. welding, non‑destructive testing) controlled?

How are these special processes controlled and monitored?

Are only suitably qualified and experienced people used to control or perform special processes?

Are all necessary controls or supporting processes available for controlling special processes (e.g. heat treatment)?

CONTROL OF INSPECTIONS, MEASUREMENTS AND TESTS

Inspection

Have programmes for inspection of items and services been established?

Do the procurement documents request that suppliers establish inspection programmes?

Have programmes for in‑service inspections been established?

Who authorizes inspection programmes?

Are such inspections conducted by qualified personnel other than those persons performing the activities?

Have inspection procedures been established?

What processes ensure that non‑conforming in‑service items are removed from use until the situation is rectified?

Are inspection hold points defined?

How is it ensured that work does not proceed beyond a hold point?

Measurement and monitoring

What processes does the organization use to measure and monitor the characteristics of its packagings, packages and conveyances to verify that the needs of customers and regulatory requirements have been met?

What processes does the organization use to release a packaging, package or conveyance to its customer?

Testing

Have test programmes been established?

How is it ensured that the test programmes demonstrate the adequacy of the specification(s) and that all parts will perform satisfactorily in service?

Is testing conducted against written test procedures, and are the acceptance criteria specified?

Who evaluates the test results?

Does testing cover normal and accident conditions of transport?

Does the management system cover calibration and control of the measuring and test equipment?

Are calibration records available, and can they be traced back to a national standard?

Is measuring and test equipment calibrated, adjusted and maintained at prescribed intervals or prior to use?

Is measuring and test equipment labelled or tagged to indicate calibration status?

If equipment is found to be non‑compliant, how is acceptance of the items reassessed?

Are controls established for the handling, storage and use of equipment?

How is inspection and test status identified, and is it maintained throughout the manufacture and use of an item?

PROCEDURES AND PROCESSES FOR CERTAIN ACTIVITIES RELATED TO PACKAGES

Have systems and control processes for handling, labelling, dispatch, carriage, receipt, unloading and storage of packages and packagings been established?

Do procedures and processes include controls for the following:

(a) The contents;

(b) Cleaning of packages;

(c) Preservation;

(d) Leaktightness;

(e) Dose rates and radioactive contamination;

(f) Turnaround and periodic inspection of package and packaging;

(g) Consumable and spare packaging components;

(h) Transport documents?

SELF‑ASSESSMENT

Has a programme been established to perform organizational self‑assessments at all levels of management to evaluate the performance of work?

INDEPENDENT ASSESSMENT

Is there a programme for internal and external audits?

Is the audit programme documented?

Are audits conducted by qualified persons who have not been involved in the activity being audited?

Are effective corrective and preventive actions taken when the system is found to be incorrect?

Are internal audit reports used for management system reviews?

Is the organization subjected to independent assessment by any of its interested parties?

How do the findings of any independent assessments compare with the findings made by internal auditing?

NON‑CONFORMANCE AND CORRECTIVE AND PREVENTIVE ACTIONS

Is there an effective system for controlling non‑conforming material?

Are the procedures for rework, use‑as‑is and repair of non‑conforming material documented and acceptable?

Is the responsibility for the review and acceptance of non‑conforming items specified?

Are accepted non‑conformances reported to the purchaser and, if necessary, to the competent authority?

Does the system provide for the detection of inferior quality and for the correction of its causes?

Is adequate action taken to correct the causes of inferior quality (e.g. design faults, defective material)?

Are analyses made to identify trends towards material non‑conformance?

Does corrective action extend to material supplied by subcontractors?

Are data analysis and material examination conducted on failed items to determine the extent and causes of defects?

Is there an effective system for registration of corrective and preventive actions and events?

Is the effectiveness of corrective and preventive actions reviewed and monitored?

IMPROVEMENT

Are appropriate arrangements in place to review and confirm that the needs of customers and other interested parties are being met?

Does the organization have a process or procedure for continuous improvement, and is it being adequately implemented?