We have delayed publication so that we could give you the latest news on the progress with revising the Ionising Radiations Regulations 1985 (IRR85). Although there has been some delay in the process we are still working to a start date of 1 January 2000.
We have included as much information as possible on how we see the recognition of Radiation Protection Advisers (RPAs) developing - including the five year transitional period - but please do not wait until 2004 before sorting out how the new system of recognition would affect you!
There are several articles based on information supplied by HSE inspectors - we hope that you continue to find such articles interesting and contain relevant information.
Issue 14 of the Radiation Protection Adviser gave details of the main themes that arose during the series of presentations in 1998 on the proposed revisions to the Ionising Radiations Regulations (IRRrev) contained in the Health and Safety Commission's (HSC) Consultative Document (CD). We have now completed the detailed analysis of the comments received and have made some changes to the proposals contained in the CD. The revised regulations and Approved Code of Practice (ACOP) were discussed by HSC's Ionising Radiations Advisory Committee (IRAC). IRAC members suggested some further changes and the final version was discussed by HSC in February. The revised regulations and ACOP, suitably amended to take account of the concerns of HSC were subsequently sent to the Minister for onward transmission to the European Commission (EC), as required by the Euratom Treaty. The EC is allowed three months in which to make recommendations. At the time of writing we are still working to a start date of 1 January 2000. The main issues of the proposed regulations are: The Minister has asked for more work to be done on this issue. Consequently, at this stage it is not included in the draft regulations sent to the EC.
As part of a wider restructuring of the accident preparedness provisions we have combined the draft requirements on prior risk assessment and the assessment for accident situations into one regulation.
Two options were discussed in the CD, the first retained the current arrangement for an annual limit but provided flexibility to apply the five-year limit in special cases; the second applied the five year limit to all employees. The first option was strongly supported, being seen as more transparent and likely to achieve greater public and employee confidence and HSC has proceeded on that basis in making its proposals to the Minister.
We accepted that the CD proposals could lead to notification of many minor events, leading to unnecessary burdens on employers and HSE. After some additional work, the original research was revised on the basis of more generic approach to likely spillage scenarios by the researchers. A revised table of values has been prepared which should eliminate the problems previously identified.
The major work on drafting revised regulations and ACOP is now almost complete - subject to any recommendations from the EC - and we are beginning to turn our attention to preparing the supporting guidance. We would like to express our appreciation again to all those who took the time and trouble to help shape the package.
Some of the provisions of IRRrev provide for HSE approval, for example authorisation or other forms of recognition, eg approved dosimetry services, prior authorisation of practices and recognition of RPAs. HSE has to ensure that a number of supporting procedures are in place before the Regulations come into effect on 1 January 2000 to permit such approvals etc. We are currently developing proposals for such procedures and are undertaking a targeted consultation.
The replacement for HSG49 The examination, testing and calibration or portable Radiation protection instruments was published in March 1999, ISSN 1386-6550, price £25 plus VAT. Copies are only available from the National Physical Laboratory, Teddington, Middlesex, telephone 0181-977-3222, fax 0181-943-2155.
This Good Practice Guide 14 has been produced by a working party of the Ionising Radiations Metrology Forum (IRMF), managed by NPL as part of the National Measurement System Programme in Ionising Radiation Metrology. The Guide is aimed at encouraging good measurement practice in this area.
HSE recently prosecuted an employer for failing to have adequate arrangements at an airport whilst handling radioactive cargoes.
The incident involved the shipment of two containers of cobalt-60 sources designed for sterilising products by irradiation. The staff were not trained in handling radioactive materials. They noticed that one of the containers was giving off heat (which is normal) and called in the Fire Services who closed the cargo centre for 3 hours until they could establish that the containers were not faulty.
The shipment of radioactive materials by air is common and is controlled by international packaging and labelling requirements. The containers of cobalt-60 met these requirements but because of poor radiological protection practices at the airport, staff were put at risk and the fire fighters dealing with the incident were exposed to radiation, but at a low level.
Lessons to be learnt from this incident include:
A radiography company, carrying out a site radiography for a pipeline contractor, failed to control the X-ray radiography triggered the emergency gamma monitoring system at an adjacent nuclear power station. Although the work was done out of normal working hours the radiography contractor had failed to establish a controlled area. This triggered a response in the power station control room. Initial measurements at the site showed radiation levels of up to 30 micro Sieverts.
The radiography contractor was prosecuted under Regulation 8(4) of IRR85, which requires that employers should not create in any area conditions which would require that area to be designated as a controlled area, unless that area is for the time being under his control. They were also prosecuted for breech of Regulation 24(4) IRR85 which requires that records of monitoring of level of ionising radiation at a designated perimeter of a controlled area should be carried out.
Lessons to be learnt from this incident include:
Issue 14 of RPA News gave details of the CIDI dose trends report for the period 1990 to 1996. Since publication we have identified an error on page 29 of the report. The figures for table 7, General Industry category for 1996 should read 3.1,0.7 (0.4), 111, 16, 2 and 2. Apologies for any confusion caused.
Registration and authorisation of keeping, use and disposal of radioactive substances under the Radioactive Substances Act will contribute to UK implementation of the BSS Directive (96/29/Euratom). The provisions of the Act and related legislation needs to be reviewed and possibly revised to reflect the revised provisions of the Directive. The Department of the Environment, Transport and the Regions (DETR) published a CD in March asking for comments on the technical aspects of the current regulations. The feedback from this short consultation will be used in a more detailed CD to be published later this year. We will keep you informed of the progress.
We have identified, with the assistance of IRAC, a number of pieces of guidance which need to be updated or recast and expanded in time for the coming into force of IRRrev (or shortly afterwards). We have started to draft several pieces of supporting guidance for the revised regulations and will shortly be consulting on our draft proposals. These pieces of guidance will be in addition to a revised version of the regulatory (non-statutory) guidance we included with the CD. This regulatory guidance will be published with the regulations and ACOP.
There is some concern about the accuracy of occupational category data submitted to HSE's Central Index of Dose Information (CIDI) by Approved Dosimetry Services. Particular problems have been found with CIDI occupational category 1 (industrial radiography using permanent shielded enclosures) and category 2 (site radiography without a shielded enclosure) .
HSE inspectors often come across incorrect use of the categories. It has also come to light that a significant number of employees in CIDI categories 1 and 2 are not actually involved in industrial radiography, for example workers involved in the use of nuclear moisture/densiity gauges in road construction - this is not site radiography - more likely to be CIDI category 51 - industrial applications not mentioned elsewhere.
In March HSE published the 1997 summary of annual doses reported to the Central Index of Dose Information (CIDI). Copies can be accessed on the Internet at site address: http://www.open.gov.uk/hse/hthdir/dose.htm
One of the areas of change in the revised regulations is the approach to the recognition of Radiation Protection Advisors (RPA). The background to this was explained in the CD and a series of questions of questions was raised there about the proposed new approach. The many comments we received as a result have helped us to continue the development of the new RPA system of recognition and we thought it would be useful to give details of the current state of play. We are currently consulting interested parties about the latest proposals on HSE Criteria of Competence for RPAs.
The Ionising Radiations Regulations 1985 (IRR85) place all the responsibility on the employer to secure the services of a suitably qualified and experienced RPA. The underlying approach of the revised regulations is to split this responsibility more even-handedly. The onus rests with the individual (or body) wishing to act as an RPA to demonstrate that they meet certain criteria of competence. The employer's responsibility is then to select from this corpus of RPAs someone who has suitable knowledge and experience of the employer's type of work. We believe this new approach remains sound and have continued with it in the final proposals approved by HSC.
In the revised draft regulations, the definition of an RPA is unchanged from that in the CD, in essence being an individual or body meeting criteria of competence specified by the Health and Safety Executive (HSE). The regulation covering the employer's duty (regulation 13 in the CD) was subject to some comments about confusion between consultation with and appointment of RPAs. The regulation has been reshaped to give a primary role to consultation.
Where a radiation employer needs advice on compliance with the Regulations (and this is mandatory for the matters listed in Schedule 5), then the employer has to consult an RPA (as defined). That RPA has to be 'suitable' and appointed by the employer in writing. Suitability in this context means having knowledge and experience relevant to the type of work the employer carries out. Written appointment is intended to formalise the arrangement between the RPA and the employer, in particular specifying the scope of the advice the RPA is required to give. A letter would often suffice for this purpose and there will no longer be the requirement, as in IRR85, to notify HSE.
Schedule 5 to the revised regulations sets out matters on which it is mandatory to consult an RPA and reflects provisions in the Basic Safety Standards Directive. Some commentators on the CD suggested that Schedule 5 should be expanded, particularly to include the detail in paragraph 75 of Part 1 of the current ACOP. We gave this careful thought, but concluded that the proper place for these additional matters was not to elevate them in status, but to carry them across to the new ACOP. As a result, an additional ACOP paragraph has been added in the appropriate place.
The means to give effect to the new definition of RPA is probably the most important issue facing us. As explained above, we are currently undertaking consultation on draft procedures we have developed. So these comments are necessarily provisional, but we hope give some feel for the shape of things to come.
The proposed structure is that HSE would recognise organisations as 'Assessing Bodies' provided they meet certain Requirements that we would specify. The key role of Assessing Bodies would be to assess individuals wishing to become RPAs for the purposes of the regulations against the HSE Criteria of Competence. If satisfied, the Assessing Body would issue a general certificate of competence. This would demonstrate that the individual had the capability to be an RPA (core competence). The Assessing Body could, additionally, choose to acknowledge special areas of expertise in the certificate, although this would not be part of HSE's Criteria of Competence and would not be considered by HSE in any recognition of an organisation as an Assessing Body. Though optional, this additional information about particular knowledge and experience in one or more sectors of work should assist, though not replace, the employer's duty to select a 'suitable' RPA. When finalised, HSE would publicise these procedures through publishing a Statement to which both the Criteria and the Requirements would be annexed.
The CD indicated that holding an National/Scottish Vocational Qualification (N/SVQ) would be an alternative to certification by an Assessing Body. This remains the case in our current proposals, but at present we believe that after five years it will be necessary for the N/SVQ holder to go to an Assessing Body for 'renewal', as the only sensible way to demonstrate continuing competence. However, before this ever starts to bite, there will be time to review how the N/SVQ process is developing.
We have always recognised that new procedures could not be introduced overnight, so the final proposals for the regulations contain a five year transitional provision. During this period, anyone who can show they have held appointment as an RPA under IRR85, can act as an RPA under the new regulations. So to those who are or have been RPAs we would say 'Don't panic', but also don't wait till the autumn of 2004 either!
One of the more difficult issues addressed in the CD was how to fit 'corporate RPAs' into the new scheme. This term refers to organisations that act as RPAs. However, the term causes some ambiguity with those (individual) RPAs who provide corporate advice in large organisations, so we have adopted a new term 'RPA Bodies', reflecting the words used in the definition of RPA.
As regards the Criteria of Competence applicable to RPA Bodies, the essential elements of our current proposals are that their personnel should include at least one individual RPA with a valid certificate from an Assessing Body and that all advice emanating from the body is traceable, through management systems and QA procedures, to a certificated RPA. This approach is also something of a halfway house between the two variants proposed in the CD, and is derived from an elegant idea we received as a result of consultation. In particular, we feel it builds neatly on the system for individual RPAs.
We hope this has been helpful in bringing you up-to-date on this most important of issues to RPAs. We believe the regulations and ACOP to be in near final form although the other procedures described here are still being developed and may yet change. For us, the establishment of Assessing Bodies is urgent to ensure a continuing flow of new RPAs. If you are an existing RPA, though, the message from the transition provisions is that you have up to five years to conform.
A waste incineration company, was recently prosecuted by HSE and the Environment Agency (EA) following the loss of two radioactive sources from an old incineration plant.
The sources, each 740 MBq (original activity) of caesium-137, were in two level gauges installed in the feed chutes of the old incinerator plant at the site. When a new plant was commissioned on the same site, the old plant was demolished. The company failed to make arrangements for the safe removal or disposal of the sources, or to make other persons aware of their presence, and the sources were lost. To date, the company have been unable to establish the fate or whereabouts of the sources. The company had previously been reminded by the EA of their responsibilities for safe removal and disposal of the sources from the plant pending its demolition.
The company pleaded guilty to charges under the Health & Safety at Work etc. Act 1974 and the Radioactive Substances Act 1993 (RSA 93) was fined.
There was a series of failures within the company to manage the removal and disposal of the two sources for which they were responsible:
The key factors contributing to all these failures were changes in management and weak arrangements for control of radioactive sources. Employees (including the RPS) who were familiar with the local rules and operation of the gauges had been moved off the old plant as soon as it ceased operation, sometime before it was demolished. The RPS was not replaced: local rules appear to have been abandoned. Indeed, there was no evidence of any management control over the gauges; it appears that they had simply been forgotten!
It is vital that management control is in place at all times during the life cycle of radioactive sources in the workplace, including disposal. Redundant equipment is particularly vulnerable to loss of control, with potentially disastrous consequences if it falls into the hands of persons who are unaware of the hazards associated with radioactive sources.
There is an increasing awareness of the hazards associated with radioactive contamination finding its way into the scrap metal chain. There have been several well-publicised incidents world-wide of extensive contamination of both production facilities and product. HSE, EA and other Government Departments are working with intermediaries in the ferrous and non-ferrous industry in the UK to raise the awareness of the radiological and financial implications of such incidents, and to emphasise how they may be avoided by the deployment of radiation monitoring equipment and associated procedures at key stages in the supply chain. HSE has set up a database to record (anonymous!) details of incidents; it is to be used to gauge the extent of the problem in the UK, including identification of the higher risk areas of the scrap supply chain, and formulate further advice to the industry about this potentially serious problem.
Existing systems have already detected several "orphan" sources which have probably originated from "scrapped" industrial equipment containing radioactive material. Recent incidents have included:
It is important that employers installing and operating monitoring systems have clearly defined procedures for managing alarms from these systems; employees and other persons must not be put at risk as a result of the rejection of a potentially contaminated load of scrap. The load must not be moved on public roads (or rail) unless in compliance with relevant legislation for transport of radioactive material. It is vital that control of the source is not lost again; it must be kept in accordance with IRR85, RSA93 or relevant exemption orders. An employer will almost certainly need to seek the advice of a specialist organisation to carry out disposal of such items.
HSE successfully prosecuted an industrial radiography company and an employee (the RPS) following an incident in an industrial X-ray enclosure.
The incident occurred in a purpose-built enclosure where two employees (the RPS and his assistant) were working to examine steel pipes. The enclosure was designed to accommodate (diagonally) the full length of the pipes. However, on this occasion, the batch of pipes was too long to fit in the enclosure. The RPS decided to defeat the electrical door interlock system by removing the switches and taping one of the switches in the closed position to simulate the "door closed" position. The long pipe was then radiographed with the door slightly open. Lead shielding was used and the area around the door was demarcated where dose rates exceeded 7.5 mSvh-1. The job was completed that day, but the door interlock system was not reinstated.
The next day a different X-ray set was used. The RPS asked the radiographer's assistant, situated at the control panel outside the enclosure, to warm up the tube by making incremental increases to the tube kV and mA during the course of a 12 minute exposure. The assistant mistakenly assumed that the warm-up period had finished and entered the enclosure. It was later established that warning lights inside and outside the enclosure were not working. He was not using a dose rate meter or alarming electronic personal dosemeter (EPD). He removed shielding which had been in place over the X-ray tube during this warm-up period, then left the enclosure. He then heard a "click" - the timer on the generator switching off the set - and realised that the X-ray set had been "ON" whilst he had been in the enclosure.
The RPS and management were notified and arrangements were made to process the dosemeter which the assistant had been wearing during the incident. The dosemeter results (197 mSv whole body) confirmed that an over-exposure had occurred. HSE was informed, and an investigation was carried out. The company was subsequently charged under IRR85 that they had not taken all necessary steps to restrict exposure (Regulation 6(1)) and that they had not taken all reasonable steps to ensure that their local rules were observed (Regulation 11(2)). The company pleaded guilty and was fined on each charge, plus costs.
The RPS, as an employee of the company, was charged under Regulation 6(4) in that he did not exercise reasonable care whilst carrying out the work. He pleaded guilty and was fined.
Following the incident, the company has carried out a comprehensive review of operations (including local rules and training), it has employed another person with specific RPS responsibilities separate from day to day production responsibilities, and the exposure warning system has been upgraded.
HSE commissioned the Institute of Physics and Engineering in Medicine (IPEM) to review the potential effects of the published Recommended Standards for Routine Performance Testing of diagnostic X-ray Imaging produced by IPEM, the College of Radiographers (CoR) and the National Radiological Protection Board (NRPB) (IPEM Report 77). The aim of the study was to establish the present level of routine performance tests carried out in hospitals and trusts in the UK and compare this with the recommendations in the IPEM Report 77.
The study found that overall 77% of the recommended tests were being carried out with 58% within the recommended time limits. Compliance was high for the analytical/physics tests which were carried out on an annual basis but lower for the more frequent and simple pass/fail tests which did not require special equipment. However, it was noted that the more complex tests were often not carried out. The study also stressed the need for routine tests to become more recognised and valued as part of the daily routine of the Department.
HSE, along with IPEM is considering the results of the study and how they will need to influence revised guidance on the Ionising Radiations Regulations 1999.
The Department of Health published a CD at the end of March on proposals to replace the current Ionising Radiation (Protection of Persons Undergoing Medical Examination or Treatment) Regulations 1988. We have worked closely with the Department of Health to ensure that these regulations are consistent with the revised Ionising Radiations Regulations.
The new regulations will be known as the Ionising Radiations (Medical Exposure) Regulations 1999. We will keep you informed on the progress with these regulations.
HSE recognises that working patterns, in particular the organisation of shiftwork, shift patterns and shift handover can have a major impact on safety issues. The revision of HSG48 (human factors guidance) contains short summaries of some key information on shiftwork and shift communications. The revised guidance was due to be published in April 1999.
There have been two incidents in the last year when nuclear battery powered pacemakers have been removed from patients leading to problems in the subsequent disposal of these pacemakers. IPEM Newsletter No 46, published on 7 April 1999 drew attention to two incidents.
The first incident involved the removal of a defective pacemaker from a patient. Disposal proved problematic and there was a delay until the transport container requirements were sorted out. The second device, fitted many years ago, was retrieved from a patient after death. The only information available was that it had been manufactured a company that had ceased trading. It was later confirmed that the nuclear battery contained 114 Gbq of 238Pu with a surface dose rate of approximately 30 µSv/hr.
Neither device carried any warning (ie suitable wording or a trefoil symbol) on their cases that they contained a radioactive source. Patients implanted with one of these devices must carry a bracelet and identity card and will have agreed to have the device removed on death.
RPAs may wish to discuss the following points with local cardiology departments to minimise the likelihood of a potentially serious problem:
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