Welcome to the thirteenth edition of the Radiation Protection Adviser. This issue appears a month earlier than normal so that we can provide the latest information on the consultation process for the revision of the Ionising Radiations Regulations 1985 (IRR85). The formal consultation document on these Regulations has been widely circulated and can be accessed on the Internet at site address:
We have also included a short analysis of the reader survey which was sent out with Issue 12. Your responses to this questionnaire will be used to shape future issues of the newsletter.
Readers will be interested in the section providing feedback from inspectors. This section contains two short articles on industrial radiography, including the latest developments in reducing the size of controlled areas.
All HSE free publications may now be obtained from:
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On 25 February the Health and Safety Commission (HSC) published a formal Consultation Document (CD) containing proposals for revised Ionising Radiations Regulations and Approved Code of Practice (ACOP). Those who would like to receive a copy can either obtain one free from HSE Books or download it from HSE's web site, see page 1. Comments need to reach HSE by 30 June.
The CD comprises a main commentary, providing background information and explaining general and specific features of the proposed revised regulations (IRRrev), followed by ten annexes. The two most important annexes contain IRRrev themselves, and a draft of the supporting ACOP and non-statutory guidance.
The commentary asks a series of specific questions about various aspects of the proposals and invites comments. These questions are laid out as a detachable proforma at the back of the CD for those who would like to use it as a convenient way to respond. Its use would also assist us in our analysis.
The background information given in the CD explains the developments in international standards and focuses on the European Union situation involving four separate Directives. The main interest is with the revised Euratom Basic Safety Standards (BSS) Directive, and the UK response in introducing changes to national legislation to meet its European obligations. The proposed regulations, as well as implementing many of the changes introduced in the revised BSS Directive, also:
A table in the commentary gives details; and
IRRrev also differs from IRR85 in its structure so as to bring out more clearly the concepts of radiation protection. The draft regulations are now set out in the following order:
We are keen to stress, and we hope that commentators will appreciate, that the changes arising from restructuring and the integration of the outside worker provisions do not of themselves change the actual legal duties.
Another major change to the 'feel' of IRRrev is the way in which it is proposed to provide supporting guidance. While HSE has over the years published many documents of subject- or sector-specific guidance, the direct regulatory guidance on IRR85 consists entirely of the four-part ACOP. It appears that the ACOP is widely appreciated and used, and that there is a general wish for the information of continuing relevance in it to be retained.
However, following a major review, in 1996 HSC published new and more restrictive criteria on the use of ACOP guidance. This has led to a large reduction in the extent of guidance of ACOP status for IRRrev, but the vacuum has been filled by a substantial amount of non-statutory guidance. An annex to the CD presents a draft of the ACOP and non-statutory guidance together with IRRrev, to show how the three tiers of the regulatory package would relate to each other. The formal purpose of the CD is to invite comments on draft revised regulations and ACOP, but the opportunity has also been taken to seek views on drafting of the guidance and the balance between it and the ACOP.
Justification and prior authorisation are significant new regulatory requirements. IRRrev has been drafted to follow the approach to justification in the revised BSS Directive.
The commentary explains the background to this issue and canvasses views on whether implementation of the Directive requirement is best taken forward as a provision in IRRrev, or as free-standing regulations. For prior authorisation, our approach has been to use existing statutory provisions wherever possible, only adding to IRRrev where gaps remain.
Another new feature of IRRrev is a requirement for the employer to conduct a risk assessment before starting work.
Risk assessment has become the starting point in the law and practice of health and safety over the last decade and is a prerequisite of effective health and safety management. It has been included in IRRrev primarily on legal advice that it is necessary to implement the BSS provision in Article 17 for a 'prior evaluation to identify the nature and magnitude of the radiological risk . . .' However, we also feel that it fits well into the new IRRrev structure, complements the general requirement in the Management of Health and Safety at Work Regulations 1992 and provides a good basis for ACOP and guidance.
Perhaps the subject most visibly associated with changing standards in radiation protection is that of dose limits. For adult workers, the revised BSS Directive allows implementation either as an annual limit of 20 mSv, or as a maximum of 100 mSv over five years. We sounded out views on these two options in an informal consultation exercise in 1996. This demonstrated some strong and opposing attitudes, and we concluded that both options needed to be fully worked up for formal consultation. Therefore the CD presents two alternative options (with associated ACOP and guidance). We are keen to receive a wide response on this issue so that HSC has the broadest basis for making a final decision.
The 1980 BSS Directive required national authorities to recognise the 'capacity to act of qualified experts' and led to the creation in IRR85 of the Radiation Protection Adviser (RPA). The fundamental requirements in the revised BSS Directive are unchanged yet this is a topic on which the CD is proposing substantial change.
The reason for this paradoxical situation is that during the intervening period the world has moved on in its expectations about formal means to recognise competence. Alert to this changing environment, HSE issued a Discussion Document about it in 1992 and followed it up with a workshop a year later. The basic options offered then - and they remain valid now - were:
Consultation showed a desire for a more positive recognition system, with the third option above clearly preferred. So the approach in the CD is to limit RPAs to those who can demonstrate competence and for employers then to choose RPAs who are suitable for their particular circumstances. This is achieved by defining the RPA as an individual or body satisfying specific competence criteria, and an annex to the CD provisionally suggests what those criteria might be. The RPA regulation then requires the employer to appoint one or more suitable RPAs. The CD poses a series of incremental questions going through the various options, to allow an update on what system for recognition will best allow us to set competency standards for the next century and implement the Directive requirement.
The CD commentary goes on to address the difficult question of bodies acting as RPAs, usually known as corporate RPAs. A distinction is drawn between those that operate solely in-house and those that may offer a commercial service to other employers. Two possible variants for recognition are identified.
The commentary of the CD draws attention to a number of other general and specific features of the proposed IRRrev and poses questions on which we would like your views.
We hope you will obtain a copy and provide us with your comments, supportive as well as critical, on the proposals generally and on the specific questions. That way the revised regulations will meet their objectives, satisfy those with an investment in their effective operation and, once again, stand the test of time.
HSE's booklet The examination and testing of portable radiation instruments for external radiation HSG49 was withdrawn in December 1997. A working party of the Ionising Radiations Metrology Forum, supported by HSE, is preparing updated guidance which is now due for publication in May or June. Copies will be available from the National Physical Laboratory, Queen's Road, Teddington, Middlesex, TW11 0LW.
Thank you to all those readers who took the time and trouble to answer our questionnaire. Generally we seem to be getting things right, but we will be looking at your suggestions in more detail over the forthcoming months - particularly your suggestions for future topics.
We received back 445 of the 3229 questionnaires we sent out - a 14% response. These replies have provided us with more detailed knowledge about our readership and we will be aiming to target your needs in future issues.
Figure 1 suggests only 55% of our readership are actually RPAs. Other readers come from a range of groups with an interest in radiation protection. Our publication must target these people as well. Inevitably, this means that there will be some readers who would prefer reports to be more detailed and technical in content, while others find the same reports too detailed.
Interestingly, whether or not they were actually RPAs themselves, 33% of readers work for organisations which act as corporate RPAs.
Figure 2 shows that the largest group who responded work in the medical/dental sector. The distribution of responses is strongly reflected in the number of requests for items specifically on the NHS and dentistry.
46% of readers appear to have read RPA News for up to three years, with 44% having read it for longer. As can be seen from Figures 3 to 6, the information provided by the newsletter is generally well received with the vast majority of readers. They find it contains the right amount of information on topics, which are easily identified and presented in an easily accessible format. 74% of respondents said RPA News contains information not easily found in other published sources.
Readers generally find legal, guidance and news items to be reasonably clearly written (see Figures 7 and 8). The response on clarity of guidance follows a similar pattern to that of these two graphs. As can be seen, there is some room for improving the clarity of these reports further and we will be looking to address this in futur e issues.
53% of respondents would be willing to pay an annual subscription charge of £8-£15 per annum should HSE find it had to make a charge for the newsletter. However, many readers stated they would want to receive it on a more frequent basis if this were the case.
56% of respondents have access to the Internet. However, only 53% of you would be willing to access the newsletter if it were only available from HSE's Home Page on the world wide web (whether or not you currently have access to the Internet).
94% of readers find the newsletter contains the information they would expect of it, but we still received many suggestions for future topics and news items. The items most frequently asked for include:
Prosecution follows contamination incident
A potentially serious contamination incident, which resulted from the poorly planned dismantling of four Americium-241 (Am-241) ;gauges, led to the prosecution of a disposal company by HSE.
The gauges, which were no longer covered by a Special Form Certificate, were safely stored at a major brewery awaiting disposal. The Am-241 source assembly of each gauge was sandwiched between two stainless steel plates, attached to which were a shutter mechanism and mounting bracket. The radioactive material was incorporated within a thin-walled, stainless steel tube.
The company that was contracted to dispose of the sources brought only one Type B container to site. The contractor intended to dismantle the gauges on site and transport all four Am-241 sources in one trip. It was discovered that the source assemblies, which were each about the size of a 13-amp fuse, were fixed in place with adhesive. The contractor's employee prised them out of their housing using a screwdriver and placed them in the type-B container. The sources were damaged in the process. The work was carried out in the back of a small van in the visitors' car park of the brewery, adjacent to a busy main road. The van driver then went to a second location about 100 miles away to collect some more equipment for disposal before returning to base.
A few days later, it was discovered that both the container and the van itself were contaminated with Am-241. Subsequent monitoring revealed that the contamination was rather more extensi ve, and included other vehicles and properties. The company reported the incident and a detailed investigation commenced. The investigation showed:
As a result of the investigation, the disposal company was prosecuted for three breaches of IRR85. A significant fine was imposed and costs in full awarded:
Regulation 6(1) Control of exposure
Alternative methods could have been used to transport the gauges without attempting to separate the sources from the plates, eg partial dismantling of the gauges, using a second or larger type B container or making two journeys to transport them.
Regulation 11 Local rules
The local rules made no reference to method statements or contingency arrangements, nor did they provide sufficient guidance on the equipment which was needed by contractor's employees.
Regulation 25 Hazard assessment
The hazard assessment made by the company was rudimentary, gave no account to foreseeable accidents, nor was it based on the correct information about the equipment in question.
Lessons to be learnt from this incident include:
Industrial radiography in small, controlled areas
HSE inspectors around the country have been following, with interest, developments in the performance of industrial site radiography in small, controlled areas. These developments allow other work to continue in safety adjacent to the radiography work and remove the need to evacuate a large area of other workers while the radiography is underway. Can a satisfactory standard of radiation protection be achieved during this work? This article gives an inspector's view of this development.
The main developments have been made through the use of source cameras, which do not require the source to leave the relative security of the shielded container. Cameras produce much more directional, better collimated beams than those produced by conventional industrial radiography collimators. Using cameras, it may be possible to achieve controlled areas smaller than 10 metres in diameter, so long as additional shielding is installed around the workpiece. Normally, a different shielding application will need to be designed for each type of workpiece being examined.
HSE inspectors have no concerns about the radiation protection principles behind this development. Indeed, using a better collimated beam with bespoke local shielding will help achieve compliance with regulation 6(2) IRR85. See paragraph 59 of Part 2 of the ACOP to these Regulations.
If the work is done properly, with the installation of effective local shielding, it is likely that radiation doses to industrial radiographers will be reduced, without significantly increased risk to persons in other trades working in proximity to the radiography. But local shielding must be installed properly and the barrier to delineate the controlled area should be correctly positioned.
A smaller, controlled area will be much easier for radiographers to supervise and to monitor during each exposure. It will also become possible for client companies to supervise how the radiography is done. This is rarely possible in the large, controlled areas used currently.
There may also be commercial advantages to working in this way, as carefully conducted radiography work done in a much smaller, controlled area will allow other work to continue in neighbouring areas. This gives the opportunity for a significant reduction in the duration of construction projects or shutdowns.
HSE guidance revised
In March, we published a revised version of HSE Guidance Note PM77 Fitness of equipment used for medical exposure to ionising radiation ISBN 0 7176 1482 4. The guidance was revised as part of HSE's general Review of Guidance. The information in PM77 has been brought up to date and its status should now be clearer. The guidance has been extended to include advice about the investigation of incidents involving equipment faults. Also, we have taken the opportunity to endorse the excellent document published by the Institute of Physics and Engineering in Medicine (IPEM) on minimum standards of testing (see Issue 12).
The IPEM guidance, which was produced jointly with the College of Radiographers and the National Radiological Protection Board, proposes a range of suitable tests and recommends remedial levels and suspension levels beyond which remedial action is needed or clinical use of equipment should be suspended. It also suggests the frequency with which these tests might be undertaken, depending on workload.
PM77 deals with the requirements of regulation 33 IRR85, which mainly concerns the capability of equipment to restrict the exposure of patients to the extent that this is compatible with the intended diagnostic or therapeutic purpose. In particular, it gives advice on the selection, installation, maintenance, calibration and replacement of equipment, and the reporting and investigation of faults in 'radiation equipment' which result in medical exposures much greater than intended.
HSE believes that employers who have control of such equipment need to provide an effective quality assurance (QA) programme. Equipment should be tested from time to time and action taken if these tests reveal that the condition of the equipment may lead to excessive patient doses.
The decision to revise PM77 was made in the knowledge that IRR85 are due to be replaced in the next few years to implement the majority of the Euratom Basic Safety Standards Directive (see earlier article 'The Revised Regulations: public consultation commences'). We will need to look at the guidance again in the light of the revised Regulations.
Copies of PM77 revised are available from HSE Books, see page 1 for details.
EC criteria of acceptability
Article 3 of the Patient Protection Directive (84/466/Euratom) requires competent authorities in Member States of the European Union to establish 'criteria of acceptability for radiological installations and nuclear medical installations'.
It goes on to say that all installations which no longer meet the criteria should be taken out of service or replaced.
The European Commission (EC) found that drawing up criteria, especially as regards the technical parameters of the equipment, sometimes created difficulties for Member States. It therefore took an initiative to prepare a report suggesting criteria of acceptability applicable to facilities in use for radiology, radiotherapy and nuclear medicine. HSE and the Department of Health assisted with the drafting of this report which was published towards the end of 1997. The UK provided the EC with later drafts of the IPEM/CoR/NRPB publication and the Commission accepted that the standards in that guidance were equivalent to the standards in the EC report.
The EC report and the IPEM guidance reflect current good practice and represent a reasonable basis from which employers can develop a suitable QA programme, taking into account the extent to which equipment is used and the appropriateness of the tests in particular circumstances. Therefore, HSE commends both documents to employers.
Reference: European Commission 1997 Radiation protection 91: Criteria for acceptability of radiological (including radiotherapy) and nuclear medicine installations Luxembourg: Office for Official Publications of the European Communities. ISBN 92 828 1140 9.
A series of reports commissioned by HSE have been published to inform decisions about the revision of IRR85. The studies have been carried out by the NRPB. The reports in this series are:
Review of experience of the Ionising Radiations (Outside Workers) Regulations 1993
Development of guidance on establishing dose constraints for occupational exposure
Review of options for designated areas in work with ionising radiations
Implications of Annex 1 of BSS Directive for users of radioactive materials
Implications for the prior authorisation of specified practices
Possible notification levels for loss and theft of radioactive sources
Possible notification levels for spillage and accidental release of radioactive sources
Criteria for programmes of monitoring of internal radiation
Doses to the foetus, embryo and new-born child following intakes of radioactivity by the mother
Copies of all the published reports are available from the Editor, see page 1 for details.
O n 26-27 November 1997, HSE held a seminar for inspectors who co-ordinate or carry out inspections of site radiography activities.
The principal aim of the seminar was to ensure a consistent approach by inspectors to site radiography, particularly on aspects such as the handling of the notifications, site and head office visits and co-ordination at both the local and national level. In addition, inspectors were brought up to date on several other topics including trends in exposure to ionising radiation, the findings of human factors research, new technologies and safeguarding their own health and safety during site visits.
Special importance was given to the need for close co-operation between site radiography companies and their clients to ensure that work is carried out in a safe manner. It is partly for this reason that HSE places a strong emphasis on the seven-day notification period to allow sufficient time for planning the work.
One of the many interesting presentations was by an external speaker Mr Alex Stephens, representing the trade association BINDT, who gave a talk on the industry's view of site radiography.
This was the third such seminar for inspectors and it is hoped to hold the next one in 1999.
Society for Radiological Protection Roadshows
SRP is arranging a series of seminars to clarify proposals for revised Ionising Radiations Regulations. These should help with responses to the HSC Consultative Document. Proposed seminars are:
6 May 1998 Kelvin Conference Centre, University
Chilton 8 May 1998 NRPB
London 15 May 1998 Institute of Physics
Manchester 28 May 1998 Royal Infirmary
Cardiff 29 May 1998 College of Medicine and Dental School, University of Wales
Further details are available from SRP, tel: 0171 287 4955;
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