Welcome to the sixteenth edition of the Radiation Protection Adviser which is entirely devoted to the Ionising Radiations Regulations 1999 (IRR99). IRR99 will come into effect on 1st January 2000. This special issue:
Regular readers of this newsletter will be aware of the process which followed publication of a Consultative Document (CD) by the Health and Safety Commission (HSC) in February 1998. Regular updates on the latest position have been provided in recent issues, for example issue:
In the main, employers working within the framework of IRR85 have been very successful in restricting exposure to ionising radiation. Annual doses reported to HSE's Central Index of Dose Information (CIDI) by approved dosimetry services reduced substantially between 1986 and 1998. So why the impetus for change? In 1996 the revised Basic Safety Standards (BSS) Directive (96/29/Euratom) was adopted, allowing four years for implementation. The Directive reflected the 1990 recommendations of the International Commission on Radiological Protection. In the United Kingdom the BSS Directive is being implemented by a combination of existing and new legislation developed by several government departments and Agencies.
What does this involve? IRR99 implement the majority of the BSS Directive provisions. Other legislation which contributes to implementation include: the Radioactive Substance Act 1993 (RSA93) and associated orders; and proposed Radiation (Emergency Preparedness and Public Information) Regulations (REPPIR). REPPIR will implement the emergency preparedness provisions of the Directive. Until REPPIR are made, current provisions in IRR85 for special hazard assessments and related contingency plans are being retained. The opportunity has also been taken to incorporate into IRR99 key provisions of the Ionising Radiations (Outside Workers) Regulations 1993, which are still necessary to implement the Outside Workers Directive (90/641/Euratom).
This need for change has provided an opportunity to revise the structure of IRR85 and to provide further clarity on the requirements, with the aim of improving coherence and understanding for duty holders. Many of the duties in IRR99 fall to the employer who works with ionising radiation (now referred to as the radiation employer). However, the actual employer (if different) of people exposed to ionising radiations has important duties eg for ensuring compliance with dose limits and for taking decisions about the need to designate employees as classified persons. In certain cases, the duty holder will be the employer who is in control of an area (or in control of equipment) or an installer or erector of articles. We have tried to make it clearer in IRR99 which employer has the principal duty to comply with particular requirements.
For employers who are already complying with IRR85 and the Management of Health and Safety at Work Regulations 1992 - which were recently superseded (S.I 1999 No 3242) - it is likely that little extra will be needed. Employers will need to review their current practices to see if further or better controls are necessary in the light of new or modified requirements in IRR99. Usually, it will be important to involve RPAs in this review process.
On the issue of justification, outlined in the CD, the Minister has asked for further work to be done, including obtaining legal opinion on the interpretation of the Directive requirement. This has meant that the development of a legal provision for justification of types or classes of practice is proceeding more slowly than IRR99 and so the draft provision has been removed from IRR99. HSC/E will continue to seek agreement on an implementing provision by the due date of 13 May 2000.
IRR99 contain several new or modified procedural requirements relating to employers who intend to work with ionising radiation or their expert advisers.
Employers carrying out certain practices must do so in accordance with a prior authorisation granted by HSE. These practices concern the use of accelerators (except electron microscopes) and also the use of x-ray sets for the following specific purposes: industry radiography; the processing of products; research; or the exposure of persons for medical treatment. This requirement, which comes into effect on 13 May 2000, will cover both existing radiation employers and employers planning to start a new practice. HSE will be issuing generic authorisations (and related guidance) for these practices, specifying conditions that must be satisfied. If a radiation employer meets those conditions authorisation is automatic: the employer does not need to apply to HSE for an authorisation. HSE believes that most such employers should be able to meet the relevant conditions. If a radiation employer cannot meet the conditions an individual application for authorisation must be made to HSE. Practices involving radioactive substances may need to be authorised under other legislation e.g. the RSA93.
Radiation employers who were carrying out work with ionising radiation on or before 31 December 1999 do not need to re-notify HSE under IRR99 unless there has been a material change in the work which would affect the information originally sent to HSE. Employers who relied on the exemption from notification under IRR85 will need to check Schedules 1 and 8 of IRR99. Some types of work previously exempt from the notification requirement under IRR85 now need to be notified to HSE.
Issue 15 described proposals for HSE criteria of competence for RPAs. Following consultation, HSE has refined the proposals. The criteria are contained in a formal HSE Statement of competence for RPAs (copies are available from the editor and HSE's web site). Discussions are underway with organisations that wish to be recognised as assessing bodies.
Individuals and organisations that wish to act as RPAs will need to satisfy HSE's criteria for core competence. Individuals will either require an NVQ/SVQ awarded at level 4 in Radiation Protection in the last 5 years or a relevant certificate awarded by an assessing body recognised by HSE. Organisations wishing to act as RPA Bodies for the first time will need to apply to HSE. However, transitional arrangements in IRR99 permit individuals or organisations that hold or have held an RPA appointment under IRR85 to continue to be accepted as RPAs until the end of 2004.
The requirements for consulting RPAs are now more specific in IRR99. Before undertaking work with ionising radiation employers may need to consult one or more 'suitable' RPAs for advice on how to comply with IRR99, except where the work falls into one of the categories listed in schedule 1. Schedule 5 specifies matters which require the advice of an RPA (e.g. the acceptance into service of new or modified sources) and the Approved Code of Practice gives practical advice on other circumstances in which RPA advice should normally be sought (e.g. investigations under IRR99). Existing employers will need to re-appoint their RPAs (or appoint another 'suitable' RPA) for the purpose of consultation under IRR99.
All dosimetry services approved under IRR85 will continue to be approved for the purposes of IRR99. HSE has, however, updated the Requirements for the Approval of Dosimetry Services (AND ASSOCIATED GUIDANCE) to bring them in line with IRR99. A revised Information Sheet on the dose assessment and recording requirements of IRR99 will shortly be available on the HSE web page (see IRR99 guidance).
The requirement to restrict exposure to ionising radiation is central to IRR99, as it was in IRR85. There is now a slightly greater emphasis on the hierarchy of control measures i.e. physical control measures should be used in preference to systems of work, so far as reasonably practicable. Consideration should only be given to the use of personal protective equipment after reducing the risk by other control measures. Also, some requirements that were only implied in IRR85 are now stated explicitly eg the duty to maintain, test and examine physical control measures. Other new elements include:
The principal dose limit is now 20 milliseiverts from external and internal radiation in any calendar year (starting from 1 January 2000). There is an exception for special cases where the employer can show that this limit is impracticable for a specific individual employee subject to strict conditions. In those special cases the dose limit will be 100 milliseiverts in five years with no more than 50 milliseiverts in a single year. The limit for trainees is 6 milliseiverts. For other people (eg members of the public) the limit is generally 1 milliseivert in any calendar year. The dose limit for an area of skin remains at 500 milliseiverts but the dose must now be averaged over 1cm2. For women of reproductive capacity, the special dose limit to the abdomen is unchanged from that in IRR85.
IRR99 requires areas to be designated as 'controlled areas' on the basis that special procedures are needed to restrict significant exposure, taking into account both normal exposure and the risk of accidents. However, the Code of Practice Approved by HSC in support of the Regulations provides continuity with appropriate standards used to determine 'controlled areas' under IRR85 (eg a reference dose rate from external radiation of 7.5 microsieverts a hour has been maintained as a starting point for decision-making). Therefore, it is likely that employers will continue with existing controlled areas in many cases.
Decisions about controlled areas should be based on the employer's assessment. Employers will need to consider: the likelihood of a radiation accident in the area; the nature of the radiation sources; the extent of the work in the areas; likely dose rates periods of exposure and the possibility of contamination. Normally, RPA advice should be sought. As a backstop, a controlled area will be needed if an employee is likely to receive an annual dose in excess of 6 milliseiverts per year in the area.
The requirement for designating supervised areas has also changed and there are additional requirements for controlled and supervised areas eg in relation to signs.
The requirement for local rules is now focused on controlled areas and where appropriate supervised areas. Local rules should contain at least a description of the area, the name of the radiation protection supervisor and necessary information about key arrangements in that area. This doesn't mean that current local rules must be rewritten; and employers can continue to make local rules for other areas if they wish. However, employers will need to make sure that local rules for designated areas at least comply with the minimum requirements of IRR99. When local rules are being reviewed in the future, employers may take the the opportunity to sharpen up the content and make them more straightforward for employees who need the information in designated areas.
HSE intends to produce a range of supporting guidance for IRR99. This will include non-statutory guidance on IRR99 (together with the Regulations and supporting Approved Code of Practice) and a range of new and revised guidance on such matters as prior authorisation, outside workers, pregnant and breastfeeding workers, monitoring equipment and equipment used for medical exposures.
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