~ Pergamon Radiat. Phys. Chem. Vol. 52, Nos I 6. pp. 631 634. 1998 ~" 1998 Elsevier Science Ltd. All rights reserved

Printed in Great Britain P i I : S0969-806X(98)00170-4 0969-806X'98 SI9.00 + 0.00

REGULATING THE OPERATION OF IRRADIATION FACILITIES IN GREAT BRITAIN: A GOAL SETTING APPROACH

David M Smith (1) & Susan McCready-Shea(2), Health & Safety Executive, UK

(1) Health & Safety Executive, Midlands Region Specialist Group, 35 Dale End, Birmingham B4 7NP, UK

(2) Health & Safety Executive, Technology Division,Stanley Precinct, Bootie, Merseyside L20 3QZ, UK

ABSTRACT

There has been a long tradition of health & safety legislation in Great Britain, going back to the 19th century. The structure of this legislation was prescriptive in nature, and targeted at particular industrial activities.

A modem regulatory system was introduced in 1974 by the Health & Safety at Work etc. Act (HSWA). These have been further reinforced by the introduction of the Management of Health and Safety at Work Regulations 1992 (MHSWR). Since the HSWA was passed, there has been a progressive reform of the law, seeking to replace industry-specific legislation with a modem approach in which regulations, whenever possible, express goals and general principles and detailed requirements are placed in codes and guidance. In this way, flexibility is allowed for technological development, within a framework of mandatory regulations.

The paper gives details of the regulations applicable to industrial irradiators in Great Britain. The approach to inspection of irradiation facilities by the Health & Safety Executive (HSE), the relevant enforcement authority under the HSWA, is described. The management structure required by the operator is outlined. Industry specific guidance and liaison with plant operators is discussed.

KEYWORDS

Irradiator: legislation: codes:guidance: inspection: inspectors: health and safety: liaison: management

HISTORICAL BACKGROUND

British legislation on health & safety in the workplace had developed in a fragmented way over the last two centuries. The introduction of legislation was often driven by public outcry at appalling conditions in factories, following the industrial revolution. For example, the first statute, the Health and Morals of Apprentices Act 1802, limited the working hours of apprentices and established minimum standards of welfare in the workplace. Enforcement was by means of visitors to factories appointed by local magistrates (a civil officer empowered to administer the law).

The Factory Act 1833 resulted in the appointment of four factory inspectors with specific powers of entry and enforcement. The Act was gradually extended to encompass other developing industries using relatively dangerous processes and practices. Similar legislation and associated inspectorates were developed over the years for the mining and quarrying industry, agriculture and offices and shops.

A characteristic of the hundreds of separate pieces of legislation was its prescriptive and restrictive nature. Regulations were introduced to target the control of specific hazards in particular industries. The means of controlling the hazard was often laid down m associated legislation (regulations) in great detail. The employer followed almost literally the letter of the law, and often had little lexibility in the approach to risk management. Hence, initiative was sometimes stifled and development and adoption of new technology was hindered by old regulations. An additional problem was the parochial nature of both the legislation and the individual inspectorate responsible for inspection and enforcement in a particular industry; there was much scope for inconsistency.

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632 David M. Smith and Susan McCready-Shea

THE HEALTH & SAFETY AT WORK ETC. ACT

The rapid changes in technology in the 1960's in Britain focused attention on the need for a fundamental review of health & safety legislation. The Government commissioned a report from a committee chaired by Lord Robens in 1972. This report led to the Health & Safety at Work etc. Act 1974 (HSWA), and the setting up of a single institution to regulate the new legal framework, namely the Health & Safety Commission (HSC) and the Health & Safety Executive (HSE), which included the different industrial inspectorates.

The HSC and HSE are public bodies with considerable independence from government. The Commission is a body of up to ten people appointed by the Secretary of State for the Environment; it in turn appoints the Executive, The Executive's 4500 staff include inspectors, policy advisers, technologists, scientists and medical advisers.

The regulatory concerns of the HSC and HSE range from health & safety in nuclear installations and major hazard chemical sites through to factories, mines, farms, hospitals and schools, offshore gas and oil installations, the movement of dangerous goods and substances, railway safety and many other aspects of protection both of workers and the public.

The Commission's statutory responsibilities under the HSWA include proposing health & safety law and standards to the government ministers. In preparing its proposals, the Commission relies on the advice of the Executive. It also consults extensively with a wide variety of interested bodies including industrial managers, trades unions and scientific and technological experts. This consultation is managed through a network of advisory committees.

Since the HSWA was passed, the HSC has been engaged in progressive reform of the law. The older detailed industry specific legislation has been replaced with a modern approach in which regulations address the control of particular hazards, and whenever possible, express goals and general principles; more detailed requirements are placed in codes and guidance. Approved codes of practice (ACOP) have a special place in British health & safety law; they set out ways of achieving standards. Those who depart from the ACOP must be prepared to show that their own approach is an equally effective way of meeting the legal requirements. In this way flexibility is allowed for technological development, within a framework set by mandatory regulations.

A fundamental principle of the British system is that responsibility for health & safety lies with those who own, manage and work in industrial and commercial undertakings. They must assess the risks attached to their activity and take appropriate action.

The need to assess risks and take appropriate action lies behind the qualification "so far as is reasonably practicable" which is widely used in British health & safety law. This, in effect,means that the duty holder needs to follow the rule of taking precautions up to the point where the cost of further action would be grossly disproportionate to the health and safety benefits.

HEALTH & SAFETY INSPECTORS

Health & safety inspectors have important statutory powers to assist them in enforcing the HSWA and the various regulations introduced under the HSWA. They can and do enter premises without warning. If they are not satisfied by health & safety standards, they can issue improvement notices requiring problems to be put right within a specified time, serve a notice to stop work either with immediate or deferred effect, or prosecute for the most serious misdemeanors.

There are approximately 1400 inspectors in the HSE. Most inspectors are trained in systems and principles applicable to a wide range activities; others specialise in a single high risk industry, for example nuclear, mining, railways, offshore oil. All are highly trained to use discretion in applying the law and to feed information back to the policy and technical centres of riSE.

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THE MANAGEMENT OF HEALTH & SAFETY AT W O R K REGULATIONS 1992

There was undoubtedly an improvement in conditions in the workplace in the decade or so following the introduction of the HSWA. The goal setting approach, supported by risk specific regulations, was applicable to every industry, new or well established; the regulatory framework was flexible enough to cope with changes in technology. In the main, physical and most health risks in the workplace were well controlled.

However, a series of major disasters in the UK during the 1980's revealed a weakness in the management of health & safety within organisations. Analysis of the reasons for the disasters often concluded that the inaction and ineffectiveness of management was the key reason for the initiating event developing into a major disaster. Similar lessons have been learned from other disasters: management and organisational issues were the paramount factors contributing to the chain of events culminating in the tragedies. It was clear that the lessons learned were equally applicable to the more humble workplace; poor management control was undoubtedly causing unnecessary loss of life and good health as a result of failure to manage the risks.

Following the adoption of a European Community Directive, the Management of Health & Safety at Work Regulations (MHSWR) were introduced in Britain with the objective of focusing attention on the importance of management control of all aspects of issues associated with health & safety. Two of the most important elements were the requirement for the employer to (a) carry out a risk assessment covering all hazards in the workplace, and identify preventative and protective measures and (b) put into place systems for the effective planning, organisation, control, monitoring and review of the health & safety systems.

The management systems required have strong similarities to systems probably already in use for achieving total quality management within strong successful companies. The use of audit and review principles is arguably the most important factor in helping an organisation to achieve good health and safety performance.

REGULATION OF IRRADIATOR FACILITIES

As already indicated, regulations have been introduced to address specific hazards to the health & safety of employees and others. The Ionising Radiations Regulations 1985 (IRR85) address the protection of persons against ionising radiation arising from any work activity. Thus, they are applicable to the user of a small radioactive source for industrial gauging, through to an industrial irradiation facility, and even occupational exposures on a nuclear power station.

Major nuclear sites (e.g. nuclear power stations) are licensed by the HSE. However, there is no requirement for specific licensing of an irradiator facility by the HSE either before commissioning or on an ongoing basis (other than on a licensed nuclear site). The employer notifies the HSE in advance of their intention to carry out the work with ionising radiation. In view of the extremely high hazard associated with the operation of an irradiator facility, the HSE would need to be satisfied that the hazard was controlled so far as is reasonably practicable before operations commenced. In practice, the HSE is consulted at an early stage (e.g. design) and during commissioning to ensure that any difficulties are identified and overcome before operations start. In the event of evidence of any serious shortcomings either in the management of the operation and/or the standards of engineering controls, the relevant HSE inspector may need to invoke enforcement powers to ensure that improvements are made to bring the plant up to standards achievable in similar installations elsewhere.

Specific guidance on irradiation facilities is given in the ACOP "The protection of persons against ionising radiation arising from any work activity". It covers (a) segregation and enclosure (b) shielding (c) exclusion of persons (d) warning signals (e) notices (f) effective devices (g) alarms (h) control of exposures (i) operational precautions (j) loading of sealed sources. However, it must be stressed that the employer is at liberty to adopt other equally effective measures to achieve compliance with the IRR85.

634 David M. Smith and Susan McCready-Shea

Over the years, HSE inspectors have gamed much useful information about the standards of operation during the course of inspection of industrial irradiator facilities m Britain. It was apparent that these standards varied from facility to facility. This experience was made available to the IAEA working group which drew up the IAEA Safety Series 107 "Radiation Safety of Gamma and Electron Irradiation Facilities' • Specific guidance was drawn up and published by HSE in 1993 (HS(G)94), with the support of the irradiation industry. It is important to realise that the purpose of the guidance was not to "rack up standards' across the entire industry, but to ensure that all operators were aware of what standards were already being achieved within their industry.

Three areas of particular interest to HSE inspectors have been contingency planning, safety systems and probabilistic safety analysis. Detailed guidance is offered accordingly in HS(G)94.

HSE Inspectors continue to liaise with the UK irradiation industry on a regular basis, in order to (a) help raise awareness within the industry of legislative issues and (b) keep abreast of technological developments in the field of irradiation processing. The HSE is a member of the "Panel on Gamma and Electron Irradiation". In this way, both the industry and the enforcement authority can benefit to mutual advantage, and thus help to improve standards of radiation satety.

CONCLUSIONS

There are clearly advantages to the adoption of a goal setting approach to the control of risks within the structure of a mature legislative system.

( 1 ) Flexibility of approach is allowed; different and developing techniques can be accommodated within the legislative framework without the need for modification to existing legislation, and there is subsequently no constraint on the technical development as long as it satisfies the goal setting principles of the legislation•

(2) The collaborative approach to establishing the legislation and acceptable standards helps to promote a sense of ownership by the industry. By definition, the standards set are achievable by the industry; this also results in these standards being enforceable in a court of law, since they are achievable.

(3) The transfer of good practice from one industry to another is promoted by the goal setting approach; there is no restriction caused by a prescriptive approach.

(4) The broad approach allows greater scope for assessing all relevant health & safety issues; inspection and advice to operators is not limited or driven by extensive lists of site licence conditions.

REFERENCES

HSWA Health & Safety at Work etc. Act 1974 H.M.S.O., London ISBN 0 10 543774 3

MHSWR Management of Health & Safety at Work Regulations 1992 Approved Code of Practice L21 London H.M.S.O. ISBN 0 11 886330 4

IRR85 lonising Radiations Regulations 1985 S.I. 1333 London H.M.S.O. ISBN 0 11 05733 1

ACOP Approved Code of Practice "The protection of persons against ionising radiations arising from any work activity" London H.M.S.O. ISBN 0 7176 0508 6

IAEA Saety Series No 107 "Radiation Safety of Gamma and Electron Irradiation Facilities" International Atomic Energy Agency, Vienna 1992 ISBN 92 0 101692 1

HS(G)94 "Safety in the design and use of gamma and electron irradiation facilities" HSE Books ISBN 0 7176 0647 3