Opinion of the Economic and Social Committee on the "Proposal for a Council Directive on the control of high activity sealed radioactive sources"

(COM(2002) 130 final)

(2002/C 241/08)

On 18 March 2002 the Commission decided to consult the Economic and Social Committee, under the second paragraph of Article 31 of the Treaty establishing the European Atomic Energy Community, on the above-mentioned proposal.

The Section for Transport, Energy, Infrastructure and the Information Society, which was responsible for the Committee's work on the subject, adopted its opinion on 19 June 2002. The rapporteur was Mr Wolf.

At its 392nd Plenary Session (meeting of 17 July 2002), the Economic and Social Committee adopted the following opinion with 123 votes in favour and two abstentions.

1. Introduction

1.1. Radioactive sources are used on a worldwide basis for a large variety of purposes, particularly in the fields of industry, medicine and research. The associated risks depend on a number of factors, including the degree of radioactivity, the different radionuclides being employed and the specific mode of employment.

1.2. As human beings do not, however, have a sensory organ which can alert them to the danger to health posed by radiation or the intake of radioactive materials, specially-developed measuring equipment has to be used for this purpose. The lack of such a sensory organ gives rise to the danger of lax use of such material and the underestimation of the possible risks; it may also, on the other hand, prompt inappropriate anxiety and rejection of possible applications for such materials.

1.3. The potential dangers inherent in the intentional use of radioactive sources are generally well-known and the use of this material is already subject to strict radiological protection rules. A particular problem is caused by radiation sources which, for various reasons, escape control ("orphan sources").

1.4. In the case of sealed radioactive sources, the radiation-emitting material must be so effectively and safely encapsulated as to rule out any escape of radioactive material into the environment under normal conditions of use.

1.5. The Commission's proposal for a Directive concerns the control of "high activity sealed radioactive sources". In the light of the accidents involving serious damage to health which have occurred in the past, the Commission defines "high activity radioactive sources" as "sources giving a dose rate at one metre distance of more than 1 mSv/h".

1.6. In view of the consequences for both public health and to the economy which may ensue as a result of accidents involving radioactive sources which are not subject to adequate control, the Commission considered itself obliged to present the proposal for a Directive under review. The proposed Directive is designed to supplement Directive 96/29/Euratom(1) which is currently in force.

1.7. The Commission's aim in presenting this proposal for a Directive is therefore to prevent undue exposure to ionising radiation as a result of the inadequate control of high activity sealed radioactive sources. The control measures already introduced by the Member States are also to be harmonised through the establishment of specific minimum requirements for ensuring that every single radioactive source meeting the requisite criteria is subject to ongoing control.

1.8. With this aim in view, and in accordance with the principle of subsidiarity, the Commission wishes to ensure that EU-wide minimum standards are observed in this sector.

2. Particular features of the proposal for Directive

2.1. The Member States are to stipulate that all activities involving the use of high activity radioactive sources require prior authorisation.

2.2. The Member States are to introduce a system for ensuring that transfers of individual high activity radioactive sources are subject to adequate control.

2.3. The Member States are to require the competent authority to maintain appropriate records of holders of authorisations and of the transfer and disposal of high activity radioactive sources on termination of the respective authorisations.

2.4. The proposal for a Directive also sets out rules governing:

- identification and marking

- training and information

- orphan radioactive sources

- guarantees, inspections and reports on experience gained.

3. General comments

3.1. The ESC basically welcomes the Commission's intentions and regards several points in the proposal for a Directive as constituting a clear improvement over the current rules. The proposed Directive would also provide the opportunity for enhancing the level of safety in the use of radioactive sources. The ESC does, however, note a lack of clarity with regard to some points, which need to be amended.

3.2. The ESC not only highlights the need for further clarification but also proposes that, in the light of the stricter rules already applicable in a number of Member States, the Commission should consider whether the field of application of the proposal for a Directive could be extended to cover sources involving lower levels of radioactivity. Under no circumstances should the field of application proposed by the Commission be rendered less strict by confining the application of the Directive to higher activity radioactive sources.

3.3. The ESC also recommends that in the descriptive part of the document the Commission should explain more precisely which individual provisions of the proposed Directive are new provisions vis-à-vis the rules currently applicable in the EU. It would, in the ESC's view, also be advisable to make a comparison in the Explanatory Memorandum between the measures proposed in the present document and the provisions already existing in the Member States.

3.4. The Committee has not examined whether the proposed measures will be sufficient to prevent the deliberate misuse of such sources and urges that this issue be considered too.

4. Special comments

4.1. The first unclear point which the ESC would highlight occurs in the definition of "high activity source" set out in the proposal for a Directive.

4.1.1. It is pointed out in point 6.2 of the Explanatory Memorandum that the Directive is to apply to sealed radioactive sources "giving a dose rate at one metre distance of more than 1 mSv/h". The following definition is, however, provided in Article 2 of the proposal for a Directive: "High activity source or source means a sealed source containing a radionuclide whose activity at the time of fabrication or of the first placing on the market is equal to or exceeds the relevant activity level specified in the Annex I".

4.1.2. Annex I does, however, comprise a table of selected radionuclides, their specified activity level and the following additional observation: "For radionuclides not listed in the table below, the relevant activity level is one hundredth of the corresponding A1 value given in the IAEA Regulations for the safe transport of radioactive materials (No. TS-R-1 (ST-1, Revised) International Atomic Agency, Vienna 2000)".

4.2. Regardless of the lack of clarity in this point, the observations made below by the ESC refer to what is surely the requirement which the proposal for a Directive intends to stipulate, namely that authorisation shall be required in respect of all activities involving the use of sealed radioactive materials having an activity level of more than one hundredth of the A1 value set out in IAEA Regulation No. TS-R-1.

4.2.1. The ESC wishes to reiterate in this context the recommendation which it made in point 3.2 above, namely that this value should under no circumstance be exceeded. Consideration should, however, even be given to setting lower limit values, in this case by specifying the exemption value. The ESC sets out conclusions in this respect under point 4.10.2 below.

4.2.2. The values proposed by the Commission are much higher than the exemption values set out under the EU basic standards laid down in Directive 96/29 Euratom; in the case of Co-60 the figures differ by a factor of 40000! The above-mentioned exemption values have also been incorporated, for example, into the German radiological protection regulation with regard to the control of sealed radioactive sources.

4.2.3. The authorisation requirement set out in the proposal for a Directive thus falls short of the existing requirement under EU law and, for example, under German law. Article 4.1(e) of Directive 96/29/Euratom stipulates a general authorisation requirement, for radioactive sources exceeding the exemption value, in respect of all such sources used for "industrial radiography or processing of products or research or the exposure of persons for medical treatment ...".

4.2.4. The requirement set out in Article 3 of the proposal for a Directive may therefore give rise to inappropriate action as the (mistaken) impression is given that the use of radioactive sources with an activity level below 1/100 A 1 is still not subject to authorisation.

4.2.5. It should therefore be clearly indicated in the proposal for a Directive that, under EU law, the use of radioactive sources having an activity level above the exemption value is already subject to authorisation in the case of sources used for industrial radiography and other special applications, as stipulated in Article 4.1(e) of Directive 96/29/Euratom, which sets out EU basic safety standards. It should also be pointed out that, under Article 3 of Directive 96/29/Euratom, the use of all other radioactive sources having an activity level above the exemption value is, at least, subject to a reporting requirement.

4.3. Article 3 establishes the important principle that prior authorisation is required for any practice involving a high activity source.

4.3.1. Article 2(a) defines the precautions which should be regarded as the standard for radiological protection under the banner of "good practice". The Committee therefore welcomes the directive's requirement that these precautions be planned and laid down in advance in the framework of the authorisation procedure.

4.3.2. The Committee also welcomes Article 3(2)(b). The requirement for "financial provision" should, however, be further specified.

4.3.2.1. One possibility would be to require firms purchasing or hiring a radioactive source to pay a deposit, refundable on return of the source.

4.3.2.2. Similarly, firms required to dispose of or reprocess used radioactive sources could be required to establish a reprocessing reserve.

4.3.3. The authorisation requirements set out in Article 3(3)(a)-(f) cover responsibilities, competencies, technical equipment, emergency procedures, work procedures and maintenance. These requirements are a clarification of existing EU rules. Article 3(3)(g) on the management and return of disused high activity sources is a new addition to the authorisation requirements, which the Committee welcomes. The requirements concerning theft prevention which have been dropped from Article 3 now appear instead in Article 6, and those concerning guarantees in Article 11. However, the Committee recommends that new requirements be added regarding the reliability of the user.

4.4. The system for the control of transfers of high activity sources provided for in Article 4 is a further development of the EU basic safety standards set out in Article 5 of Directive 96/29. The Committee recommends that this rule be extended to require the holder of a radioactive source to check, before a transfer is made, that the recipient holds an appropriate authorisation.

4.5. The system of records proposed in Article 5 goes further than current practice.

4.5.1. Thus for example, the current practice in Germany is that a holder is allowed to handle, store and appropriately dispose of a radioactive source only in the area to which the authorisation applies. As a result, locating radioactive sources has so far posed no problem. This requirement does, however, place a high degree of reliance on the holder.

4.5.2. The system of official records proposed in Article 5 appears an appropriate safeguard against unreliable holders. The requirement that the holder report to the authorities at least once a year will prevent the disappearance of radioactive sources going unnoticed for years. The Committee considers this provision too appropriate.

4.6. Article 6 deals with the requirements for holders.

4.6.1. First, the Committee points out once again that there are no minimum requirements for the reliability of the operator, and the Committee recommends that this omission be rectified. (See also point 4.3.3)

4.6.2. The other provisions of Article 6, such as regular leak tests, physical checks, measures to guard against fire and theft, and the requirement to report any loss promptly are to be welcomed.

4.6.3. The requirement to return used sources to the supplier (in return for refund of the deposit) is a new element which is also wholeheartedly welcomed.

4.7. The rules set out in Article 7 regarding the identification and marking of sources are state-of-the-art. The phrase "written information" requires further clarification, however. It also needs to be made clear whether this information is required to be carried during every transport. At all events the container should also carry information on the radionuclide and the initial activity.

4.8. Article 8 covers training and information. The Committee considers that the article should be more clearly worded.

4.8.1. For example, Article 8(1) does not define the persons to be trained and informed. In the case of mobile sources the relevant persons are the responsible team leader, the staff using the source and those responsible for transport. These persons must receive information on handling, loss and emergency procedures and reporting requirements.

4.8.2. The safety culture required in dealing with radioactive sources should be mentioned in the preamble and then, as a development of this, the persons required to be trained and informed defined in Article 8. The persons concerned are those:

- either working permanently or temporarily with a radioactive source or using it for their work. These persons should be informed of the nature and physical properties of the source and its radiation, and also of possible risks and safety requirements to be complied with in handling the source;

- or for various reasons may be in the direct vicinity of the radioactive source, e.g. for cleaning, transport etc. These persons should receive introductory and follow-up information on conduct and regulations, and they should also be drawn from among a firm's most reliable employees.

4.8.3. With regard to the timetable for training, the Committee recommends:

- that initial and regular refresher training and information be provided for staff using radioactive sources or working in the immediate vicinity of sources,

- that training be repeated under specific circumstances, and specifically geared to those circumstances (e.g. special applications, transport etc).

4.9. Article 9 covers the action to be taken in the event of radioactive sources being lost: orphan sources. This provision is important and necessary.

4.9.1. Checks to detect the presence of radioactivity at scrap yards and smelting works have already been carried out in the Member States in the past in order to prevent the occurrence and spread of radioactive contamination. Before the EU draws up formal requirements for the Member States, the Committee recommends that the Commission give detailed consideration to the cost of any measures - especially for SMEs - before opting for a particular procedure.

4.9.2. The provisions should specify the frequency of checks and the procedures to be followed. The sensitivity of the tests and the measuring procedures should also be defined in detail.

4.9.3. Finding orphan sources where there is efficient shielding or where no high-energy gamma radiation is present is, however, likely to be difficult. The popular belief in the reliability of detection methods could even under certain circumstances lead to those affected developing a false sense of security.

4.9.4. In this context, it is also unclear what exactly is meant by the phrase "campaigns for recovering orphan sources".

4.10. With reference to the content of point 4.1, the Committee points out that the table in Annex 1, which defines the scope of the directive, is difficult understand and needs to be clarified.

4.10.1. Thus, maximum activity levels are related to A1 values rather than dose rate values. The statement that these values are equivalent to 1 mSv/h at a distance of 1 m. is not generally speaking correct; the intake risk also plays a part in relation to A1 values.

4.10.2. In general, it also needs to be asked whether it makes sense to limit the directive to sources with activity exceeding 1/100 A1. Many, although not necessarily all, of the directive's provisions could, the Committee feels, be extended to all sources with activity above the exemption values.

5. Conclusion

5.1. In principle, the Committee welcomes the intention, and to a great extent also the content, of the proposal for a directive, many aspects of which are a clear improvement on the rules currently in force

5.2. In relation to a number of points, however, the Committee feels that the proposal needs to be revised, clarified, and its content amended.

Brussels, 17 July 2002.

The President

of the Economic and Social Committee

Göke Frerichs

(1) Council Directive laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation - OJ L 159 of 29.6.1996.