Select Committee on Trade and Industry Written Evidence

Annex A



  1.  The safety of nuclear installations in the UK is assured by a system of regulatory control based on a licensing process by which a corporate body is granted a licence to use a defined site for specified activities. This document describes how HSE regulates the design, construction and operation of any nuclear installation for which a nuclear site licence is required under the Nuclear Installations Act. Such installations include nuclear power stations, research reactors, nuclear fuel manufacturing and isotope production facilities, fuel reprocessing and the storage of radioactive matter in bulk.

  2.  The following bodies have roles in developing and implementing the regulatory regime:

    (a)  the Health and Safety Commission (HSC) was established by the Health and Safety at Work etc. Act 1974 (HSW Act). The Commission's primary function is to make arrangements to secure the health, safety and welfare of persons at work, and the public, in the way that undertakings are conducted. This includes proposing new law and standards, conducting research, providing information and advice, and controlling explosives and other dangerous substances.

    The Commission is appointed by, and reports to, the Secretary of State for Work and Pensions, though it may report on specific matters to other Secretaries of State as appropriate. In particular, on nuclear safety matters in England and Wales it advises the Secretary of State for Trade and Industry and, in Scotland, the Secretary of State for Scotland. In preparing proposals for health and safety law and standards the HSC relies on the advice of the Health and Safety Executive. The HSC is also advised by the Nuclear Safety Advisory Committee (NuSAC). The functions of NuSAC are:

—  To advise the HSC on major issues affecting the safety of nuclear installations including design, siting, operation, maintenance and decommissioning which are referred to it or which it considers require attention;

—  To advise the HSC on the adequacy and balance of its nuclear safety research programme.

    The Commission has general oversight of the work of the Health and Safety Executive and has power to delegate to the Executive any of its functions. However the HSC is precluded from giving directions to the Executive about the enforcement of the HSW Act in any particular case.

    (b)  the Health and Safety Executive (the Executive) is the three-person corporate body statutorily appointed to enforce health and safety law under the general direction of HSC. It is the licensing authority for nuclear installations;

    (c)  the organisation commonly referred to as "HSE" is the body of people who deal with almost all aspects of industrial safety under the authority of the Executive. HSE's staff are engaged in developing health and safety policy, inspecting the premises of duty-holders and enforcing health and safety legislation, investigating work-related accidents and complaints, and providing information, guidance and advice on health and safety matters;

    (d)  the Nuclear Safety Directorate (NSD) is a freestanding directorate within HSE. NSD's mission is:

"To secure effective control of health, safety and radioactive waste management at nuclear sites for the protection of the public and workers and to further public confidence in the nuclear regulatory system by being open about what we do."

    (e)  the Nuclear Installations Inspectorate (NII) is that part of NSD to which the day-to-day exercise of the Executive's licensing function is delegated.


The Health and Safety at Work etc Act 1974

  3.  The operators of nuclear plants in the UK, like their counterparts in other industries and places of work in general, are required to comply with the Health and Safety at Work etc. Act 1974 (HSW Act). The HSW Act places a fundamental duty on employers to ensure, so far as is reasonably practicable, the health, safety and welfare at work of all their employees. It also imposes a duty to ensure, so far as is reasonably practicable, that persons not in their employment are not exposed to risks to their health or safety as a result of the activities undertaken.

Reducing Risk, and the ALARP principle

  4.  In determining whether any measures are necessary to reduce risk and achieve compliance with the HSW Act employers should consider both the cost of those measures, whether in money, time or trouble, and the risk which would be averted by their implementation. In industries which have the potential for accidents with severe consequences, and where there is perhaps significant uncertainty in these considerations, such measures should be implemented unless the cost is obviously disproportionate to the risk which would be averted. In short, risks must be reduced to a level which is as low as reasonably practicable (the ALARP[93] principle). This concept and the way in which nuclear risks are regulated in the UK is explained in HSE's publication "The Tolerability of Risks from Nuclear Power Stations", and further promulgated in HSE's "Reducing risks, protecting people".[94]

The Nuclear Installations Act 1965 (as amended)

  5.  Relevant parts of the nuclear industry must also comply with the Nuclear Installations Act 1965 (as amended) (NI Act) which has three purposes:

    (a)  it requires the licensing of sites which are to be used for the operation of nuclear reactors (except for reactors which form part of a means of transport) and certain other classes of nuclear installations which may be prescribed;[95]

    (b)  it provides for the control of the processes and the application of security measures associated with the enrichment of uranium and the extraction of plutonium or uranium from irradiated matter; and

    (c)  it sets up a special legal regime to govern the liability of the licensees towards third parties for certain kinds of damage (primarily nuclear damage) caused by nuclear matter on, or coming from, their sites.

  6.  The first of those purposes, the licensing and inspection of sites, is within the ambit of HSE whilst the other two are the responsibility of the Secretary of State for Trade and Industry, for sites in England and Wales, and Scottish Ministers for Scotland. Brief details are provided below.


  7.  Under the NI Act, apart from certain exemptions, no site may be used for the purpose of installing or operating a nuclear installation unless a licence has been granted by the Executive and is in force. The sections of the NI Act relating to the licensing and inspection of sites (sections 1, 3 to 6, 22 and 24A) are "relevant statutory provisions" of the HSW Act. Thus these sections of pre-existing law are subject to HSW Act arrangements for regulation and enforcement. Further details of the licensing and inspection regime are provided below.

The nuclear site licence

  8.  The safety of nuclear installations in the UK is achieved by a system of permissioning based on the nuclear site licence. The entry point to this system is the licensing process by which a corporate body is granted a licence to use a defined site for specified activities. Nuclear site licences are granted for an indefinite term and, in principle, one licence can cover the lifetime of an installation from design, siting, construction, commissioning, operation, and modification through to eventual completion of decommissioning.

  9.  A licence is not transferable, but a replacement licence may be granted to another corporate body. Other circumstances, which may lead to the need to relicense a site, include changes to the site boundary and changes to the types of prescribed activity for which the site is licensed. Before a replacement licence is granted HSE considers the same evaluation criteria as it would for an initial licensing, but takes a proportionate approach and focuses particularly on those aspects of the licensing basis which are the subject of the change.

  10.  Each nuclear site licence is unique to its site. It may be varied by the Executive to exclude any part of the site which the licensee no longer needs for licensable activities. Before granting a Variation the Executive is required by the NI Act, section 3(6), to be satisfied that there is no danger from ionising radiations from anything on that part of the site.

  11.  A licence may be revoked by the Executive or surrendered by the licensee. However, depending upon the circumstances, the licensee may be required to retain responsibility for the safety of activities and/or materials on the site. This "period of responsibility" is ended only when a new licence has been granted for the site or the Executive has given written notice that in its opinion there has ceased to be any danger from ionising radiations from anything on the site. Before such a notice is issued the Executive needs to be satisfied that the site has been decommissioned and decontaminated to the requisite standard.

Licence conditions

  12.  The NI Act provides that the Executive shall attach to each nuclear site licence at the time of granting it such conditions as may appear to the Executive tobe necessary or desirable in the interests of safety. HSE may at any time attach further conditions to the licence, including conditions relating to the handling, treatment and disposal of nuclear matter. HSE also has power to vary or revoke conditions, so providing scope for the licence to be tailored to specific circumstances and the phase of the installation's life.

  13.  HSE has developed a standard set of 36 conditions which are attached to all nuclear site licences and which cover safety related functions such as:

    —  marking the site boundary;

    —  the appointment of "suitably qualified and experienced persons" to perform any duties which may affect the safety of operations on the site;

    —  the production of adequate safety cases for all operations affecting the siteand the preservation of records;

    —  the handling and storage of nuclear material;

    —  incident reporting and emergency arrangements;

    —  design, modifications, operation and maintenance;

    —  control, supervision and training of staff;

    —  decommissioning arrangements and programmes; and

    —  control of organisational change.

  14.  The licence conditions, in the main, require the licensee to make and implement adequate arrangements to address the particular issues identified. Each licensee can develop licence condition compliance arrangements which best suit its business whilst demonstrating that safety is being managed properly. Similarly the arrangements made to comply with them may change as the plant progresses through its life from initial design to final decommissioning. The 36 standard licence conditions are reproduced in full at, together with some explanatory text.

  15.  Although the licence conditions provide the basis for regulation by NII they do not relieve the licensee of the responsibility for safety. They set goals which the licensee is responsible for meeting, amongst other things by applying detailed safety standards and safe procedures for the plant. The arrangements, which a licensee develops to meet the requirements of the licence conditions, constitute elements of a safety management system. NII reviews the licensee's licence condition compliance arrangements to see they are clear and unambiguous and address the main safety issues adequately. Procedures which comply with nuclear site licence conditions are likely to satisfy the requirements of other health and safety legislation under the HSW Act in relation to nuclear safety hazards at nuclear licensed sites, eg the Management of Heath and Safety at Work Regulations 1999.

Operational methods

  16.  The Executive has delegated the nuclear licensing function to senior officials within NII which therefore has the responsibility for granting licences and attaching appropriate Conditions. NII also makes judgements on the acceptability of responses made by licensees to the requirements of those Conditions.

  17.  Nuclear Installations Inspectors are appointed under the HSW Act. They administer the NI Act and deal with nuclear and radiological safety issues at licensed nuclear sites. Non-nuclear health and safety aspects are also monitored and regulated either by NII or by Inspectors drawn from other parts of HSE. Operational approaches employed in carrying out these duties include prior assessment of the safety of proposed nuclear plant designs and operational regimes and inspection of the implementation of the licensee's licence condition compliance arrangements.


  18.  Assessment is the process by which NII's assessors, who are themselves inspectors and technical experts in specific fields, establish whether a licensee's demonstration of safety is adequate. The technical standards, which NII uses to judge a licensee's safety case, are expressed in HSE's Safety Assessment Principles (SAPS), which are available to licensees and the public ( Risk can never be avoided altogether and, normally, safety means the control of risks to an appropriately low level.

The Safety Case

  19.  A safety case is the totality of documented information and arguments developed by the licensee which substantiates the safety of the plant, activity, operation or modification in question. It provides a written demonstration that relevant standards have been met and that risks have been reduced to a level which is as low as reasonably practicable (ALARP). The safety case is not a one-off series of documents prepared to obtain a nuclear site licence but an holistic, living framework which underpins all safety related decisions made by the licensee. The safety case is required to be updated regularly and the implications of proposed plant and other safety related changes need to be examined against it and, when necessary, additional demonstration of safety provided. Accordingly, the requirements to produce and maintain safety cases[96] are embodied in the conditions attached to all nuclear site licences.


  20.  Inspection at site and, as necessary, at the licensee's corporate headquarters and elsewhere, enables NII to check compliance with licence conditions, safety cases and other legal requirements. It provides a basis for enforcement and other regulatory decisions. Inspectors also seek to advise and encourage the operators of plants to enhance safety where this is consistent with the ALARP principle. Nuclear licensed sites are subjected to a high level of inspection, one or more site inspectors being allocated to a site. A site inspector typically spends around 30% of his or her available time at site. Much of the remaining time is spent reviewing the licensee's justifications of safety with other site inspectors and with technical assessors.

  21.  Additionally, the NII mounts team inspections on particular topics. These may be regular events, such as witnessing the annual demonstration emergency exercise for a site, or special inspections on a selected aspect of safety. Team inspections typically involve a mixture of site inspectors and technical assessors.


  22.  All inspection and assessment is done on a sampling basis, the size and scope of the sample being determined by, for example, the potential hazard of the activity and the findings from initial examinations. This reflects the normal regulatory practice of targeting and proportionality, whilst retaining the basic principle that safety is the responsibility of the licensee. It depends for its success on a suitably qualified and experienced Inspectorate, on the accuracy of information supplied by the licensee, and on the readiness of the licensee to report to the Inspectorate matters which have safety significance.


  23.  All of the HSE's enforcement powers are employed in accordance with the HSC's Enforcement Policy Statement.[97] In exercising the delegated licensing function NII makes use of a number of controls derived from the NI Act and the licence conditions. These enable NII to:

    (i)  grant a licence to an applicant;

    (ii)  attach conditions to the licence, and to vary or revoke those conditions;

    (iii)  vary a licence, to reduce the area of the licensed site;

    (iv)  Consent to particular actions, usually to the commencement of a given activity;

    (v)  Approve particular arrangements or documents, generally to "freeze" them so they cannot be changed without NII agreement;

    (vi)  Notify the licensee that it requires certain information to be submitted eg a safety case;

   (vii)    issue Specifications to require the submission of particular documents for examination, or Specify that something must be done in a particular way, eg form of waste material;

  (viii)    issue Agreements as a means of agreeing to particular plant or process modifications;

    (ix)  Direct the licensee to shut down particular operations;

    (x)  Revoke a nuclear site licence.

  24.  The first three of these are comparatively infrequent events, as are (ix) and (x). Most of the remainder, ie (iv) to (viii), are likely to be much more frequent, and generally reflect the rate of change on the site. They result from requests from, or applications made by, a licensee (or prospective licensee). In general they will have been signalled to HSE in advance of receiving the formal request, and will often be the subject of considerable discussion, during which the views of each side will be well aired, before the NII exercises its powers.

  25.  NII may from time to time reject or refuse a licensee's formal application. On occasion the NII may deem it necessary to call on its reserve power to issue a Direction to close down particular operations for safety reasons.

  26.  NII inspectors may also use their enforcement powers under the HSW Act to issue Prohibition and Improvement Notices and to prosecute for breaches of that Act or the relevant statutory provisions. Breaches of licence conditions are offences under the NI Act for which the licensee, and any other person having duties upon the site who causes the breach, may be prosecuted.


  27.  Nuclear site licensees, like all duty holders under the HSW Act, have the right of appeal to an industrial tribunal in respect of Improvement and Prohibition Notices.[98] However section 44 of the HSW Act specifically prevents nuclear site licensees from making appeals to the Secretary of State in respect of licensing decisions made under the provisions of the NI Act. This reflects the nature of the hazard being regulated and the complexity of the technical arguments which will underlie most key licensing decisions. However, where a licensee remains dissatisfied following representations to the appropriate site inspector and his/her line management in NII, it may ask the Executive[99] to review the process by which the decision has been reached.

International obligations

  28.  As a Member State of the European Union, the UK is bound by legislation set down under the Euratom Treaty relating to radioactive substances. The Euratom Treaty established the European Atomic Energy Community. The UK became a signatory of the Treaty on its accession to the European Union in 1972.

  29.  The UK is also a Member State of a number of international organisations with an interest in radioactive substances. These include the OECD Nuclear Energy Agency (NEA) which contributes to the development of nuclear energy as a safe, environmentally acceptable energy source, and the United Nations International Atomic Energy Agency (IAEA) which promotes the safe use of radioactive substances through a series of Safety Standard documents setting down best practice in the fields of nuclear energy production, radioactive waste management, radioactive materials transport safety and radiation protection. In its mission statement the IAEA records that it:

    —  is an independent intergovernmental, science and technology-based organisation, in the United Nations family, that serves as the global focal point for nuclear cooperation;

    —  assists its Member States, in the context of social and economic goals, in planning for and using nuclear science and technology for various peaceful purposes, including the generation of electricity, and facilitates the transfer of such technology and knowledge in a sustainable manner to developing Member States;

    —  develops nuclear safety standards and, based on these standards, promotes the achievement and maintenance. of high levels of safety in applications of nuclear energy, as well as the protection of human health and the environment against ionising radiation;

    —  verifies through its inspection system that States comply with their commitments under the Non-Proliferation Treaty and other non-proliferation agreements, to use nuclear material and facilities only for peaceful purposes.

  30.  As a Member State the development of the UK regulatory regime is influenced by the work of the IAEA and the standards it promulgates. In particular the UK is a signatory to two important international conventions developed under the auspices of the IAEA.

The Convention on Nuclear Safety

  31.  The Convention on Nuclear Safety was drawn up during a series of expert level meetings from 1992 to 1994 and was adopted in Vienna in June 1994.  Its aim is, to legally commit participating States operating land-based nuclear power plants to maintain a high level of safety by setting international benchmarks to which Member States subscribe. The obligations of the Parties are based to a large extent on the principles contained in the IAEA Safety Fundamentals document "The Safety of Nuclear Installations". These obligations cover for instance, siting, design, construction, operation, the availability of adequate financial and human resources, the assessment and verification of safety, quality assurance and emergency preparedness.

  32.  The Convention is an incentive instrument. It is not designed to ensure fulfilment of obligations by Parties through control and sanction but is based on their common interest to achieve higher levels of safety which will be developed and promoted through regular meetings of the Parties. The Convention obliges Parties to submit reports on the implementation of their obligations for "peer review" at meetings of the Parties to be held at the IAEA.

The Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management

  33.  The Joint Convention applies to spent fuel and radioactive waste resulting from civil nuclear reactors and other applications, and to spent fuel and radioactive waste from military or defence programmes if and when such materials are transferred permanently to and managed within exclusively civilian programmes, or when declared as spent fuel or radioactive waste for the purpose of the Convention by the Contracting Party. The Convention also applies to planned and controlled releases into the environment of liquid or gaseous radioactive materials from regulated nuclear facilities. The Convention entered into force on 18 June 2001.

  34.  The obligations of the Contracting Parties with respect to the safety of spent fuel and radioactive waste management are based to a large extent on the principles contained in the IAEA Safety Fundamentals document "The Principles of Radioactive Waste Management", published in 1995. They include, in particular, the obligation to establish and maintain a legislative and regulatory framework to govern the safety of spent fuel and radioactive waste management and the obligation to ensure that individuals, society and the environment are adequately protected against radiological and other hazards, inter alia, by appropriate siting, design and construction of facilities and by making provisions for ensuring the safety of facilities both during their operation and after their closure. Like the Convention on Nuclear Safety, the Joint Convention requires Parties to submit reports on the implementation of their obligations for "peer review" at meetings of the Parties to be held at the IAEA.

  35.  The text of the Conventions and the UK's reports on their implementation can be accessed via

Environmental Regulation

  36.  The requirements for the protection of the environment and the authorisation of discharges of radioactive waste from nuclear licensed sites are the responsibility of the Environment Agency for England and Wales, and the Scottish Environment Protection Agency for Scotland. The Environment Act 1995 amended NIA65 to place a statutory obligation on HSE to consult the appropriate environment agency before:

    "granting, varying or revoking a licence, or attaching,. varying or revoking a licence condition, if the condition relates to or affects the creation, accumulation or disposal of radioactive waste within the meaning of the Radioactive Substances Act 1993"

  37.  In addition to statutory requirements for consultation, HSE, EA and SEPA are committed to working together to deliver effective and efficient regulation of the nuclear industry, to maintain and improve standards of protection of people and the environment from the potential hazards from ionising radiations, and to ensure that radioactive wastes are appropriately managed in both the short and long term, in accordance with legislation, UK Government policy, and international obligations. The working arrangements between HSE and the environment agencies have been set out in a Statement of Intent (see, and Memoranda of Understanding (see for the HSE/EA Memorandum and for SEPA).

Regulatory Costs

  38.  Section 24A of the NI Act enables HSE to charge licensees for the expenses associated with its nuclear site licensing and inspection work (NB in this context the term "licensee" includes applicants for licences as well as those who already hold licences). Licensees are charged for the direct cost of NII's regulatory activities, its expenses including administrative support staff within NSD, and a proportionate share of the costs of HSE's central services. The total costs are distributed between licensees on the basis of the percentage of inspector time allocated against their sites. In this way each licensee pays the true economic cost of licensing rather than the marginal cost of direct inspection effort on an individual site.

  39.  The charges may also include the cost of research and of nuclear safety studies commissioned to assist NII and ensure that it has access to independent technical advice and information. These costs are allocated to licensees according to the nature of the work done under each contract.

Public Register

  40.  A public register of companies holding nuclear site licences, with details of their sites, is available at


  41.  The safety of nuclear installations in the UK is the responsibility of holders of nuclear site licences and is assured through a system of regulatory control. The regulatory regime which HSE/NII operates under the terms of the Nuclear Installations Act requires that all actions by the licensee which may have significance for nuclear safety are subject to vetting and approval by HSE/NII before changes are implemented. It is therefore described as a "permissioning" regime since HSE is able to require that the licensee obtains its agreement before, for example, substantially modifying or altering operating arrangements. The HSC policy statement "Our approach to permissioning regimes" explains the regulatory philosophy within which NII operates the nuclear licensing regime: it is available at

  42.  The nuclear permissioning process is unique in that the safety case, which supports compliance with the licence, is subject to continuous review. Hence the resources and effort to deal with an individual duty holder are spread over the lifetime of the installation rather than falling at discrete periods determined by legislation.

93   As Low as Reasonably Practicable-the ALARP principle is fundamental to the regulation of health and safety in the UK and requires that risks should be weighed against the costs of reducing them; measures must then be taken to reduce or eliminate the risks unless the cost of doing so is obviously unreasonable compared with the risk. Nil's Technical Assessment Guide for inspectors "Demonstration of ALARP" is available at Back

94 Back

95   These other classes of nuclear installations for which licences are required are prescribed via the Nuclear Installations Regulations 1971 (SI 381). Back

96   For guidance on the scope and content of safety cases see Back

97   See the HSC publication "Enforcement policy statement" at http// Back

98   see HSW Act section 24. Back

99   ie the three-person corporate body established in accordance with sections 10(1) and 10(5) of HSWA. Back

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