1.1. History Summary

1.  SUMMARY

1.1.  History Summary

Following the 2003 Transport Conference a committee was established by the Director General to advise the IAEA to coordinate an international work plan to address issues of delay and denial of shipment. This committee has met eight times, concluding its work in 2013.

1.2.  Investigation into causes of denial

The initial work focussed on collecting information on the instances of delay and denial. This was mainly carried out by recording information supplied on standard forms in a database managed by IMO. Various issues were identified, such as confidentiality of information, which made data collection difficult, however over time industry made informal reports avoiding this confidential information issue (although this could not be recorded on the database effectively).

Analysis showed that the reasons for denial could be distilled into a limited number of root causes which will be used to inform the future data collection.

1.3.  An action plan to combat denial

The Steering Committee set out a challenging action plan with some 200 actions in six categories (awareness, communication, economic, harmonisation, lobbying and training) to combat denial. Over time many of these actions have been completed and some have been consolidated together. In 2012 the outstanding list of actions had reduced to around 10. There have been several successes, and some of the actions are noted to be important to carry into the future.

1.4.  Current status

The work of the ISC over the past seven years has led to the creation of a network of national focal points, a database recording reports of denials, a set of training packages and a communication strategy. These have been essential elements of the response to denial and provide a strong platform for moving forward.

An analysis carried out on the database identified the different reasons of denial which are being used for future recording of denial.

There exists an ongoing number of denials, but there is now a more proactive approach being taken by all involved, building on the platform.

A crucial part of the mechanism is the network of national focal points which provides a benefit in terms of denial, and also provides numerous additional benefits (for example assisting in return of sources found in transport).

1.5.  Looking Forward

Although the term of the International Steering Committee term is coming to an end the instances of denial will continue. The Steering Committee function, which delivered the mechanism to deal with denial, is coming to an end; the maintenance of the mechanism and ongoing monitoring still requires some oversight.

1.5.1.  TRANSSC

The IAEA Transport Safety Standards Committee will take the role of being a central focal point for the networks on denial. By combining the network with this committee there are clear synergies where the geographic distribution of the National Focal Point network can enhance the work of TRANSSC, while the membership of TRANSSC can enhance the number of contact points in member states.

1.5.2.  Inter-Agency Group

For many years an informal inter-agency committee has been held by IAEA to focus on harmonised regulations for the transport of radioactive material. The committee has expanded over time to include specific attendees (e.g. industry groups) for particular action points. It is intended that this committee will be extended to form a wider inter-agency group taking on some of the ongoing oversight of denial actions.

An important aspect of the ongoing work is the support of the IAEA Technical Cooperation Department, which provides regional and inter-regional projects to assist with many of the activities that prevent denial.

2.  BACKGROUND

2.1.  What is a Denial

Generally, denial can be defined as a shipment in which a problem was encountered while in transport.

At its 5th meeting, the International Steering Committee (ISC) agreed on a definition for denial as follow: “a (explicit or implicit) refusal to carry a shipment of radioactive material though it conforms to all the applicable Regulations”. Therefore, non-compliances with applicable Regulations cannot lead to Denial Reporting/Notification.

Nonetheless, there was still some debate within the ISC on this definition and a final definition could not be agreed upon and was being discussed during the 8th meeting.

In general, there is a lack of agreement around the world about the extent of denial. This is partly because industry is, in fact, finding sub-optimal, costly and time consuming solutions to getting their product from one destination to another which has economic and social consequences.

For instance:

• Denial and delay to the transport of radiopharmaceuticals is reducing the distances they can be transported resulting in doctors having to send patients to other locations for treatment.

• Cobalt 60 is not able to be transported by sea to some countries, e.g. the Far East, causing an immediate problem for the sterilisation of medical products.

• Transport costs for radiopharmaceutical producers are around 14% of production costs in Europe but depend on geography.

• Reports have indicated uranium shipments are being delayed at ports for weeks.

Although alternative routes and longer journeys are often possible and used, these add complexity and cost as well as potential risk to safety and security. This complexity has been shown to be a precursor to absolute denials of shipment.

2.2.  The 2003 Transport Conference

In July 2003 the International Conference on the Safety of Transport of Radioactive Material noted that the nuclear industry and other industries using radioactive material were facing a reduced availability of transport routes, modes and carriers as a result of decisions by commercial carriers, ports and handling facilities not to accept radioactive material. The Conference suggested that the International Atomic Energy Agency should work more closely with the Modal Organizations of the United Nations and with Non-governmental Organizations in determining why shipments of radioactive material were being denied, and develop a strategy for addressing this issue.

There has been a number of meetings discussing the issue of delay and denial of shipment, including IAEA Fact Finding Discussion Forum convened at the International Maritime Organization (IMO) headquarters in London 16 July 2004, the IMO Facilitation Committee (FAL) At the 19-23 July 2004 IMO FAL meeting held in London and the ICAO Dangerous Goods Panel Working Group of the Whole who discussed the issue of denials of shipments for radioactive material at its meeting in Abu Dhabi, 4-8 Oct. 2004.

The Agency’s General Conference has been particularly interested in this subject. In GC(48)/RES/10C operative para 12 the 2004 General Conference welcomed “the progress made on the problems related to refusals of shipments of radioactive materials (in particular for medical applications), and looks forward to a satisfactory resolution of this issue.”

In September 2005, the Agency’s General Conference encouraged the Agency to continue addressing this matter by establishing a steering committee. This resolution was reaffirmed at the 2006 General Conference.

2.3.  The 2011 Transport Conference

In 2011, on the fiftieth anniversary of the issue of the IAEA’s first Regulations for the Safe Transport of Radioactive Materials in 1961, the IAEA held the Conference on the Safe and Secure Transport of Radioactive Material.

The transport of radioactive material is an expanding worldwide activity involving the movement of products that are essential and necessary for public health, manufacturing, science, and engineering. In spite of the long established regulation of the safe and secure transport of nuclear and radioactive material, recent years have shown that transport operations are increasingly being faced with delays and denials. This results in unwarranted actions, rerouted journeys, and increases in financial and human resources creating frustration for the parties concerned.

The objective of the conference was to encourage application of appropriate levels of safety and security during transport by promoting international discussion on the safety and security of radioactive material transport; identifying and sharing best practices, issues and problems, opportunities, such as providing assistance, to support national adoption of comprehensive transport safety and security frameworks and developing ideas for coordinating and enhancing transport safety and security.

The conference outlined the fact that denial of shipments continues to be a problem which must be addressed. Denial of shipments can adversely affect security – e.g., if a package is left at a facility, it might be misplaced or abandoned. Efforts to reduce denials have both safety and security benefits. In addition, it was noted that denial of shipments was also hindering radioactive source returns as well as beneficial uses involving radioactive material.

Consistency between IAEA, IMO and ICAO regulations and thereafter IATA and national regulations was seen as an important aspect in avoiding denial of shipments and fostering increased compliance.

As a follow-up to the Conference, a Technical Meeting (TM 43650) was held to produce a report of recommended activities to address the Conference President's Findings of the Conference on the Safe and Secure Transport of Radioactive Material. The outline of work prepared for the Technical Meeting summarized the Conference President's Findings under eight topical areas including: Harmonization, Denial of Shipments, Basis of Provisions, Safety Requirements and Security Recommendations, National Implementation and Industry Compliance, Emergency Response, Communications and Regional Considerations.

The Technical meeting (TM 43650) examined ongoing and planned activities in the Transport Safety Work Plan, the Transport Security Plan of Work, and the International Steering Committee Action Plan for denials of radioactive material shipments. These activities were grouped and summarized under the eight topical areas in the Conference President's Findings. The review of ongoing and planned activities was useful in providing background information on active IAEA transport-related work so that the Technical Meeting deliberations on recommendations could be provided in the context of already initiated IAEA activities.

In addition, a second Technical Meeting (TM 44897) was convened to further review all actions related to the outcome of the conference. Within this Technical Meeting, Working Group 2 was tasked to review the items related to denial of shipment to identify potential revisions to the regulations that would reduce incidences of denial. The working group was also to review draft Security Requirements Documents to identify security requirements in the documents that could lead to denials if they were to be implemented along with any changes in the transport regulations that could preclude this and finally, a review of the provisions of the ISC action plan to determine if any of the provisions would require a change to the regulations.

Working Group 2 generally did not identify any changes that might be needed to the Transport Regulations as a result of their review, but recognized that more comprehensive review/revision process for the 2012 edition of the IAEA Transport Regulations that was underway might provide recommendations for change related to the issues reviewed.

2.4.  The Database on Denial

The problems of denial and delay are affecting the ability to cost-effectively transport radioactive materials to where they are required the world over. Thus there continues to be an urgent need for a universally accepted approach to solving this problem. Efforts made by the Agency to address the issue indicate that the main reasons of the refusals include:

• Apprehension and negative perception on the part of carriers and public authorities about radiation.

• Concerns about extent and cost of training.

• Multiplicity of regulations and regulators within a State and lack of harmonization in regulations between States.

• Lack of awareness and public outreach about the need to use and transport radioactive material and the consequences of denials, and the safety standards in practice and high safety performance.

While there is evidence of instances of denial and delay, there was no accurate measure of the nature and extent of the issues. To this effect the International Maritime Organization (IMO) and the IAEA established a database around an agreed data format. The purpose of this database was to enable IAEA and modal organisations to analyse reports of problems and facilitate resolution of underlying issues. The commitment of international organisations and Member States to actively encourage the reporting of instances of denial and delay using the database was important in providing a full picture.

No report equals to no denials; it means that complete harmonization between countries relevant regulations (including local regulations) has been obtained. Reporting instances of denials and delays make stakeholders aware of the problem and start actions aiming to minimize or eliminate such instances. To this effect, a report form was developed for reporting sustainability problems in transport of radioactive material.

Once a denial is reported, an analysis of the denial (causes and root causes) is completed and an action plan to solve this denial (corrective and preventive actions) is developed. A periodical analysis of the new reports by both Regional Coordinator and Denials Secretariat provides input to updates.

Based on feedback received, the form was recently simplified by removing the collection of specific details in an effort to increase the number of denial being reported.

2.5.  The International Steering Committee

Radioactive materials are used for medical diagnosis and therapy, sterilization of medical products, industrial purposes and for power production. These materials need to be transported from a production site to the place of use. In accordance with the mandate of the International Atomic Energy Agency to promote safe applications of radiation for peaceful purposes, the Agency publishes and periodically updates Regulations for the Safe Transport of Radioactive Material. The Transport Regulations which serve as the basis for many international and national regulations assure a high degree of safety. Instances of refusal to carry radioactive cargo and of permission to conveyances having aboard such cargo, despite conformance with the regulations, have been reported in the recent years. Such refusals have resulted in hardship to patients and other users of radioactive material.

As a result an International Steering Committee on Denials of Shipments of Radioactive Material has been constituted to further these efforts. This Committee was responsible to coordinate international efforts at resolution of issues related to the denial of shipments. This Committee satisfied the recommendation of General Conference resolution GC/49/RES/9B.

The objectives of the Committee were to serve as a mechanism to facilitate the coordination of a comprehensive international work plan of activities conducted by the organisations of the Committee membership related to delays and denials of shipments of radioactive material.