APPENDIX 1
Memorandum from the Health and Safety
Executive
THE USE OF MRI EQUIPMENT: THE EU PHYSICAL
AGENTS (ELECTROMAGNETIC FIELDS) DIRECTIVE
EXECUTIVE SUMMARY
HSE has implemented Government policy on restriction
of exposures to Electromagnetic fields (EMFs) in a consistent
and proportionate manner for many years. Government policy has
been developed after careful consideration of the conclusions
of national and international reviews of the scientific evidence
of harm. HSE and the Department of Health have led the move to
share information and ensure a joined up approach across all Government
Departments and associated organisations providing a strong basis
for restriction of exposures to EMFs.
INTRODUCTION
1. The Health and Safety Executive (HSE)
is a non-departmental public body with specific statutory functions
in relation to health and safety, which reports to the Health
and Safety Commission (HSC). HSE receives scientific advice on
matters of radiation protection from the Radiation Protection
Division of the Health Protection Agency (HPA-RPD), which has
a statutory duty to advise the Government, and from other sources.
HSE employs a number of Specialist Radiation Inspectors who review
the advice and work with policy colleagues to decide the best
use that can be made of it.
THE EU PHYSICAL
AGENTS (ELECTROMAGNETIC
FIELDS) DIRECTIVE
AND MAGNETIC
RESONANCE IMAGING
2. The Electromagnetic Fields Directive,
to be transposed into law by April 2008, is based on international
guidelines for restrictions on exposure to EMFs. These guidelines,
designed to prevent the onset of adverse acute effects on health,
have also been adopted by the HPA who, following their reviews
of the scientific literature, consider that they provide the appropriate
level of protection for people.
3. The Directive applies to all workers
who are exposed to EM fields including those using magnetic resonance
imaging (MRI) equipment. During negotiations on the Directive,
the Council and the European Commission took account of concerns
expressed by representatives of the electro-medical equipment
manufacturers and others that, pending further international reviews
of the science, the ELVs should not include static magnetic fields.
4. More recently, concern has been expressed
by those engaged in MRI related work that the Directive is likely
to have an adverse impact on the continued use of MRI equipment
with current specifications, this effect being particularly severe
in the healthcare sector. The practitioners argue that during
either diagnostic scanning or interventional treatment of patients,
they are likely to be unable to comply with the applicable ELVs
during certain modes of operation. This, they argue, may prevent
them from using this technique. Their arguments also extend to
questioning the strength of the scientific evidence upon which
the ELVs are based, together with a view that adverse effects
are not experienced when these are exceeded.
5. HSE has considered these views and held
a meeting of stakeholders to discuss the issues on 5 January 2006.
It took place in conjunction with the Department of Health (DH)
and the Medicines and Healthcare products Regulatory Agency (MHRA)
and was chaired by a senior HSE official assisted by an independent
facilitator. It was a positive meeting at which all stakeholders
had an opportunity to express concerns. HSE officials are now
considering what action to take to address the issues raised and
progress implementation in partnership with key stakeholders.
A report of the meeting will be placed on HSE's website.
SOURCES AND
HANDLING OF
ADVICE
What impact are departmental Chief Scientific
Advisers having on the policy making process?
6. Evidence based policy is an essential
part of HSE's core business and pivotal to the achievement of
its PSA targets. The HSC Science Strategy 2005-08 sets out how
HSE will apply science to provide a sound evidence base to help
deliver the HSC's vision and mission to protect people's health
and safety by ensuring that risks in the changing workplace are
properly controlled. See: http://www.hse.gov.uk/science/strategy0508.pdf.
The Chief Scientist is responsible for HSE's science policy and
direction and is committed to ensuring that its policies are based
on the best available scientific advice, in line with the recently
revised Government Chief Scientific Adviser's (GCSA's) "Guidelines
for the use of Scientific Analysis in Policymaking",
2005. HSE has produced a statement for the implementation of these
Guidelines at: http://www.hse.gov.uk/science/gl2000res05-04.pdf.
The Chief Scientist monitors, annually audits and reviews implementation
of the Guidelines, ensuring that they are assimilated into HSE
practice and that the principles are widely understood and applied.
As a member of the HSE Board, the Chief Scientist is also able,
where appropriate, to advise the Board on the significance, validity
and use of scientific advice provided to the policy makers.
7. HSC receives integrated scientific and
technical policy advice from some Subject Advisory Committees,
which comply with the GCSA's Code of Practice for Scientific
Advisory Committees. See: http://www.hse.gov.uk/aboutus/hsc/iacs/index.htm.
What is the role of the Government Chief Scientific
Adviser in the policy making process and what impact has he made
to date?
8. The Office of Science and Technology
will discuss the role and overall impact of the GCSA. HSE has
valued the GCSA's role in independently assessing its performance
in obtaining and using scientific evidence in sensitive areas
of policy making, eg Asbestos regulations.
Are existing advisory bodies being used in a satisfactory
manner?
9. The responsibility for the way that medical
equipment is used rests with the individual healthcare providers
within the overarching general advice and guidance provided by
DH or agencies such as MHRA. HSE has regulatory oversight of compliance
by employers with the relevant health and safety legislation and
recognises the need to work closely with MHRA on specific safety
issues. This is consistent with HSE's policy of using existing
and relevant bodies where appropriate rather than creating new
ones. In 1993 a forerunner of the MHRA prepared "Guidelines
for Magnetic Resonance Equipment in Clinical Use". This
was revised in 1997, and again in December 2002. The medical professional
bodies (Institute of Physics & Engineering in Medicine, Royal
College of Radiologists, British Institute of Radiology, College
of Radiographers, British Association of MR Radiographers) were
all represented and consulted during the drafting process. A manufacturers'
trade association was also consulted. The National Radiological
Protection Board (now HPA-RPD) and HSE also participated. MHRA
have indicated that they intend to review this publication in
2006-07. HSE intends to participate in this review.
Are Government departments establishing the right
balance between maintaining an in-house scientific capability
and accessing external advice?
10. HSE's in-house science and engineering
capability (approximately 25% of staff numbers) is used to support
the development of policy, to make regulatory judgements on the
acceptability of risk controls in technically complex industrial
environments and to investigate incidents arising from the failure
of those controls. This in-house capability includes the Health
and Safety Laboratory (HSL), and in-house agency of HSE with 250
scientists and engineers who carry out high quality research and
forensic investigation work. External expertise is used to meet
short-term shortages, provide expertise for which HSE has no long
term need, especially in the investigation of major incidents,
and provide independent scientific advice on particularly complex
issues.
11. HSE regularly reviews the use it makes
of science. The most recent of these reviews reported to the HSE
Board in 2004. This review looked both at the level of support
HSE's businesses required from science and the make-up of that
science. It concluded that, whilst the overall proportion of resource
dedicated to science was broadly right, HSE needed to increase
its Social Science and Human Factors capabilities balanced by
some reduction in its engineering capability. Changes in demand
for support had already brought a substantial expansion of HSL's
social science group and a decline in its Fire, Explosives and
Engineering groups.
12. The balance between the use of external
and internal specialist expertise is also subject to scrutiny.
Whilst in the past it would have been the norm for guidance on
industry good practice to be prepared by HSE it is now becoming
more usual for the work to be undertaken by an industry working
group with input from HSE.
13. Traditionally HSE has made limited use
of external science in its frontline activities because of the
inability of external experts to make regulatory judgements. However,
this position is being reviewed in a study that seeks to draw
on the experience of other government departments and private
industry organisations.
14. As well as using external expertise
directly, HSE's specialists maintain strong networks with industry
and academia, exchanging information and research findings, and
exploring ways of improving risk control methodologies.
RELATIONSHIP BETWEEN
SCIENTIFIC ADVICE
AND POLICY
DEVELOPMENT
What mechanisms are in place to ensure that policies
are based on available evidence?
15. HSE is in the unique position of having
a first rate scientific staff, comprising almost 800 in-house
specialists across a very broad range of disciplines, under the
same command as those responsible for policy-making and delivery.
HSE has organised its specialists to facilitate the provision
of effective support and thereby ensure that policy and delivery
plans are based on sound science. For example, the successful
development of HSE's Management Standards for work-related stress
depended on a robust scientific understanding of the causes of
stress at work. To ensure this happened, a team of HSE's Occupational
Psychologists were fully integrated into the policy development
team for the duration of the Standards' development. A key aspect
of the development of the Management Standards was a series of
workshops specifically aimed at canvassing the expert views of
scientists and practitioners working in the field of occupational
stress.
16. HPA-RPD has a statutory function of
providing scientific advice to Government on radiation matters
and HSE's specialists act as the route by which this advice is
incorporated into HSE policy-making. In formulating its advice
the HPA adopts a multi-faceted approach consisting of extensive
reviews of the scientific literature, workshops with invited experts
to address specific issues and consulting with the wider scientific
community. The output is made freely available on their web site.
The resulting draft advice is then considered within HSE and as
appropriate by other Government Departments (OGDs) and attention
is drawn to apparent gaps or lack of clarity. This process of
consulting fully and widely ensures that the advice from which
policies are derived is based on the available scientific evidence.
Are departments engaging effectively in horizon
scanning activities and how are these influencing policy?
17. HSE has set up a horizon scanning system
to systematically anticipate, identify and prepare for new or
changing risks. The system is looking ahead three to 10 years
to inform strategic thinking, planning and decision-making. It
encompasses the full range of social, behavioural, scientific,
technological, political and economic issues related to workplaces
and work activities. HSE also participates in appropriate DTI
Foresight initiatives; especially the recent programme "Exploiting
the Electromagnetic Spectrum".
18. HSE commissioned HPA-RPD (formerly NRPB)
in 1993 to produce a report on the potential impact of the first
proposals for a Physical Agents (EMFs) Directive. This report
and subsequent addendum to take account of changes proposed by
the European Commission in August 1994 was published as NRPB R-265.
The probability of a revived proposal for a Directive on EMFs
adopting international guidelines was anticipated by HSE in 2001
and HPA-RPD was again commissioned to review the published evidence
to indicate potential impact on UK industry. Their report was
published in September 2002 (NRPB W24).
19. HSE part sponsored an International
Workshop (hosted at HPA-RPD in April 2004) to look at the fundamental
science of interactions of the large static magnetic fields employed
in MRI systems with people. The identified gaps in knowledge have
been incorporated into a revised Agenda for Research published
by the WHO International EMF Project.
Is Government managing scientific advice on cross-departmental
issues effectively?
20. In 1994 an Interdepartmental Liaison
Group was established to ensure the effective discussion of cross-departmental
issues on non-ionising radiation. This forum comprises officials
from OGDs, the devolved administrations, HPA and other regulators
(eg Ofcom and Ofgem). It is a good example of joined up Government
and one that allows the sharing of information and consideration
of scientific advice. For MRI, regular discussions have taken
place between HSE, DH and the MHRA. This has ensured the consistent
and effective application of scientific advice, and HSE's development
of policy has taken OGD's views fully into account.
TREATMENT OF
RISK
Is risk being analysed in a consistent and appropriate
manner across Government?
21. HSE played a leading role in the Government's
Risk Handling Improvement Programme and is maintaining strong
contacts with OGDs to develop consistent risk analysis and management
tools and methodologies.
22. The current sensible risk management
debate and revision of publications such as "5 Steps to Risk
Assessment" are opening up issues to the public and risk
analysis professionals. This should ensure that the issues are
thoroughly discussed, and result in the development of high-level
sensible risk management principles endorsed by the wider health
and safety and risk management communities.
23. HSE's guidance for inspectors and other
staff to assess whether risks have been reduced as low as reasonably
practicable (ALARP) has been publicised internally, and made publicly
available through its website.
Has the precautionary principle been adequately
defined and is it being applied consistently and appropriately
across Government?
24. Through its central role in the UK Interdepartmental
Liaison Group on Risk Assessment (ILGRA), HSE led on producing
a document[1]
that defined and analysed the use of the precautionary principle.
This work was passed to HM Treasury when ILGRA was disbanded in
favour of the structures set up under the Risk Handling Improvement
Programme.
25. HSE's policy and practice on using the
precautionary approach in addressing hazards subject to high scientific
uncertainty is published in its decision making framework document
"Reducing Risks, Protecting People".
How does the media treatment of risk issues impact
on the Government approach?
26. Specialist journalists, including those
in the national media, tend to provide balanced and accurate coverage,
but when stories become headline news the effect of sub-editors
and other non-specialists can be unpredictable. The media imperative
to gain readers/viewers can lead to coverage becoming unbalanced.
This is not always the case, for example, current coverage of
the Buncefield fire is, in many instances balanced, but it creates
problems when coverage is slanted to create a "good"
story.
27. Where this happens criticism may be
levelled at the regulator/government and it becomes necessary
for government to present a balanced view to ensure that proportionate
action can be taken. Media coverage may sometimes either exaggerate
or be dismissive of incidents or issues, which may lead to public
over-reaction, or when issues are played down, make appropriate
action difficult because the public do not take it seriously.
In circumstances where public/stakeholder cooperation is necessary
balanced media coverage is important.
28. Unbalanced media coverage of health
and safety issues and incidents, linked with popular accounts
of the "success" of a compensation culture can lead
to employers or others being excessively risk averse and bureaucratic
in their approach. Engaging directly with journalists to ensure
they clearly understand risk issues or appreciate the parameters
in which risk is properly considered, demands considerable Government
resource. HSE has specifically committed resource to communicate
effectively the case for sensible health and safety controls,
and promoting the management of risk, not its elimination.
TRANSPARENCY, COMMUNICATION
AND PUBLIC
ENGAGEMENT
Is there sufficient transparency in the process
by which scientific advice is incorporated into policy development?
29. HSE's aim, when formulating its approach
to address a new problem or policy issue, is to make all stakeholders
aware of its plans. Diverse mechanisms are used, including both
formal and informal meetings with key sectors, trade organisations,
small and medium enterprises, employees and pressure groups and
all those likely to have an interest in the issue. As well as
setting out its ideas, HSE invites views and takes these into
account. Where appropriate, HSC will also publish consultation
documents. These describe how HSE intends to use scientific advice
and provide consultees with the opportunity to comment. This process
also embodies an internal challenge on account of HSC representing
a wide range of informed stakeholders. The nature of received
comments is also made freely available to enable consultees to
see the extent and the way in which these have been incorporated
into the policy making process. The HSC holds its meetings in
public and HSC papers and the minutes of its meetings are posted
on the HSE web site wherever possible. In summary, HSE adopts
a policy of complete openness.
Is publicly-funded research informing policy development
being published?
30. HSE's policy for the implementation
of the CGSA Guidelines on the Use of Scientific Analysis in Policy
Making is that all research findings involved in the process of
decision-making are published and publicly available on HSE's
website free of charge. HSE's science web pages, which were redesigned
in Autumn 2003 and are continually updated, are at: http://www.hse.gov.uk/science/index.htm.
They provide access to technical reports produced from HSE research
as well as a projects directory for work commissioned since 2001.
Feedback on projects commissioned is welcomed and the directory
enables users to comment on the work being undertaken. Research
reports available on HSE's website include CRR 226 (1999) "Assessment
and management of the exposure of workers to electromagnetic fields
in the workplace" and RR 338 (2005) "Measurement
and analysis of magnetic fields from welding processes".
Is scientific advice being communicated effectively
to the public?
31. A new e-newsletter, HSE Science and
Research Outlook (http://www.hsesro.com/), provides information
on all aspects of HSE's science programme together with an opportunity
for public comment. Alongside the newsletter, foresight reviews
will be published and comments invited from stakeholders.
32. HSE's Infoline provides the public with
a readily accessible source of technical advice on general health
and safety issues. Statements may be prepared, with input from
appropriate HSE specialists, in anticipation of events that may
raise public awareness of an issue. When issues arise through
the media, information sheets will be prepared for use by both
Press Office and Infoline. Detailed technical support is provided
to answer complex or obscure questions. Informal feedback from
users of Infoline supports its effectiveness.
EVALUATION AND
FOLLOW-UP
Are peer review and other quality assurance mechanisms
working well?
33. HSE works with other partners and stakeholders
as part of its process to quality assure research outputs. Processes,
which are proportionate to the particular projects, range from
internal review through to external peer review, presentations,
workshops and publications in peer-reviewed literature. Formal
peer review of outputs from individual projects or groups of projects
is undertaken where relevant. However, although valuable, much
of this external input is received at the end of research projects
and HSE aims to establish better mechanisms for involving academic
and professional institutions at the beginning of the process,
eg constructive partnerships to assist in the development of more
coherent programmes of research. HSE's Competition of Ideas exercises
provide a mechanism to present broad issues (or specific policy
questions) to the research community who are invited to put forward
proposals.
34. The Chief Scientist manages HSE's science
budget in accordance with business needs and priorities, exercising
an appropriate challenge function with regard use of public funds,
competition, etc. Owing to the nature and breadth of HSE's work,
it is not appropriate to establish standing external review arrangements
for proposal appraisal. The requirement for peer review is notified
at the proposal development stage and detailed on the Project
Record Form. Details of newly commissioned research work are posted
on HSE's research project directory, that allows for comments
to be attached. In respect of the current case study, a project
entitled "International expert workshop to review the interactions
of static magnetic fields relevant to possible adverse health
effects in people" was hosted by HPA-RPD) and was reported
in a focussed issue of Progress in Biophysics & Molecular
Biology, Vol 87, Nrs 2-3, Feb/April 2005. Links are provided
to outputs from completed projects at:
http://www.hseresearchprojects.com/ProjectSearch.aspx.
35. HSL undertakes periodic audits involving
international teams of renowned scientists to assure the quality
of its science. The reports of these science audits are published
on the HSL website.
What steps are taken to re-evaluate the evidence
base after the implementation of policy?
36. HSE adopts various approaches, eg, by
participation in scientific fora both at European and global level
it can identify early warnings on possible changes to the fundamental
evidence base or if new risks appear. HSE also liases with officials
who attend meetings such as Cooperation in Science & Technology
organised by the European Commission.
37. HSE and DH have been key sponsors of
the WHO International EMF Project from its inception in 1996.
A programme of international technical seminars reviewed the published
research database and identified critical gaps in knowledge. A
WHO agenda for research was published that has acted as a priority
list for funders. Many current research projects worldwide are
now assessing the health risks from exposures to the different
regions of the electromagnetic spectrum. Any changes in scientific
understanding will lead to a review of decisions to ascertain
whether existing policy needs amendment.
January 2006
1 This document "The Precautionary Principal:
Policy and Application" was published on the ILGRA website
at Ministerial agreement. http://www.hse.gov.uk/aboutus/meetings/ilgra/pppa.htm2 Back
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