Impact Assessment (IA) for the evaluation of a potential legislative measure in the area of Transport of Radioactive Materials (TRAM)
Consultation period: 26/11/2007 - 28/01/2008
TRAM: multifaceted substances under a complex legal framework
Renewed interest in nuclear power generation, and increasing need for medical applications (sterilization, diagnostic and therapeutic radioactive sources), will result in the need to transport more and more radioactive material safely and efficiently.
The legal framework ruling the transport of radioactive materials is rather complex, since it is based at the same time on International Agreements and on Community regulations, these last stemming from both EC and Euratom Treaties. All TRAM legislation had as primary objective the safety in the transport.
The regulatory complexity is mainly due to the own nature of the radioactive material, which is classified under the generic concept of "dangerous goods" and, on the other hand, it also includes miscellaneous substances that could contain fissile and/or non-fissile isotopes. The large majority of shipments (4.000 every day in the EU, on average) concerns medical isotopes.
Where two or more regulatory bodies have the mandate to regulate the transport of radioactive materials depending on the mode of transport, it is a continuing challenge to ensure that their roles and interfaces are clear.
Some of the issues:
Also, specific legal issues regarding security, safeguards, dual-use or civil liability as regards radioactive materials, have also to be considered in many cases due to the particular features of some radioactive material to be transported.
Need of transparency in TRAM activities
The transport of radioactive materials has always attracted the interest of the public and the media, although the number of related accidents or incidents (events) with safety consequences is unusual. In addition, according to a recent survey of the European Commission [Special Eurobarometer about radioactive waste (2005)] the transport of radioactive materials is one of the major fears of European citizens concerning radioactive waste, in such a way that seven out of ten EU citizens believed that even the transport of low-level radioactive waste presented a risk.
TRAM activities enable to carry radioactive materials out from behind the factory perimeter fence and into the community, on to the highways, on air, and the railways. The smallest incident involving the transport of radioactive materials, no matter the lack of any real or potential radiological consequences, has the potential to play to people’s fears.
Then, the necessity of transparency by informing and communicating to the public safety issues concerning the transport of radioactive materials should be a major issue for National Competent Authorities. For that purposes, the availability of systems of information and data collection as well as reporting is important to learn from any such events.
In the case of the transport of nuclear (fissile) materials the need of information and transparency is even higher because of strong feelings it raises among the public. But this need for transparency could be also conflicting with guidelines (INFCIRC/225/Rev. 4, Recommendations for the Physical Protection of Nuclear Material.), developed by the IAEA. These recommendations set an objective for States to establish conditions which would minimise the possibilities for unauthorised removal of nuclear material or for sabotage and requires that appropriate measures, consistent with national requirements, should be taken to protect the confidentiality of information relating to transport operations, including detailed information on the schedule and route.
In this context the Commission has launched an Impact Assessment to support decisions about simplification of the legislative framework for TRAM
The identification of problems is based on the Fifth Report on the Standing Working Group (SWG) on Safe Transport of Radioactive Materials in the European Union (COM(2006) 102 final) as the most legitimate instrument mandated by the European Parliament to identify such problems. Thus, delays in transport, denials of transboundary shipments, the need of more transparency about shipments and the important administrative burden associated to such activities, usually with strong differences from a Member State to another, are the most common problems raised by the SWG.
Such problems could create obstacles to the free movement of goods and, hence, to a sound implementation of the internal market of radioactive materials.
Thus, denial of shipments of radioactive materials intended for use in medical diagnosis and treatment continued to be a major issue. The vast majority of denials were for air transport, which is, in most cases, the only practical method to ensure these materials reach their intended destinations in a timely manner.
Besides, delays in transport of medical radioisotopes could substantially affect their therapeutic properties, mainly for those of short half-life. Finally, the lack of transparency concerning the transport of nuclear materials could create public concerns towards nuclear activities in general.
Main policy options
In addition to continue with Business as usual option (no actions), two main policy options appear: