Annex A
THE REGULATION OF NUCLEAR INSTALLATIONS IN
THE UK
INTRODUCTION
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 LAW
AND THE
REGULATORY REGIME
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.
Licensing
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 http://www.hse.gov.uk/nuclear/silicon.pdf,
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.
Assessment
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 (http://www.hse.gov.uk/nuclear/saps.htm). 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.
Inspection
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.
Sampling
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.
Enforcement
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.
Appeals
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 http://www.hse.gov.uk/nuclear/legal.htm.
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 http://www.hse.gov.uk/nuclear/sofi.pdf,
and Memoranda of Understanding (see http://www.hse.gov.uk/nuclear/nucmou.pdf
for the HSE/EA Memorandum and http://www.hse.gov.uk/aboutus/framework/mou/sepa-nuclear.pdf
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 http://www.hse.gov.uk/nuclear/licensees/pubregister.pdf.
Overview
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 http://www.hse.gov.uk/enforce/permissioning.pdf.
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 http://www.hse.gov.uk/nuclear/tast/tast005.pdf Back
94
http://www.hse.gov.uk/risk/theory/r2p2.pdf 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 http://www.hse.gov.uk/nuclear/tast/tast05l.htm Back
97
See the HSC publication "Enforcement policy statement"
at http//www.hse.gov.uk/pubns/hsc15.pdf. 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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