Memorandum 8
House of Commons Science and Technology
Select Committee Inquiry "Scientific Advice, Risk and Evidence:
How Government Handles Them" 2005-06 Report: Watching the
Directives: Scientific Advice on the EU Physical Agents (Electromagnetic
Fields) Directive (Fourth Report of Session 2005-06 HC 1030)
In its response to the above report in October
2006, the Government acknowledged criticisms of the process of
negotiating the Directive, and indicated a strong intention to
learn lessons from this episode. This memorandum seeks to update
the Committee on general developments in the field since the Government's
response in October 2006.
Work in relation to the EMF Directive has continued
in partnership with stakeholders including those in the medical
community, those from other sectors such as the manufacturing
organisation, EEF, and other government bodies. The Health and
Safety Executive (HSE) has worked throughout the year with the
European Commission and other Member States on concerns about
the Directive.
HSE published research into the impact of the
Directive on MRI in June 2007. This confirmed the concerns of
the MRI community that some procedures, as currently practised,
could expose workers to EMFs above the exposure limit values set
out in the Directive, and brought this to the attention of the
European Commission.
In the light of this and other evidence, the
Director General of the Directorate General for Employment and
Social Affairs has written, most recently in July 2007, to Member
States with a commitment to take action including a possible postponement
of the implementation date of the Directive. The most recent of
these letters is at Annex 1.
Other relevant improvements made by HSE and
other government bodies to ensure similar problems do not arise
again are outlined below, many of these already underway in advance
of the Committee's Inquiry.
IMPACT OF
THE EMF DIRECTIVE
ON MRI (RECOMMENDATIONS
IN PARAGRAPHS
76 AND 78)
1. Progress has been made toward resolving
issues relating to the possible impact of the Directive on MRI.
In addition to work mentioned above, the following can be noted:
Research
2. The Wellcome Trust, Medical Research
Council, Cancer Research UK and Engineering and Physical Sciences
Research Council have conducted a survey of UK MRI researchers
to assess the potential impact of the EU Physical Agents (EMF)
Directive on research of clinical and public benefit. This found
that research using MRI, as currently practised, could also expose
workers above the exposure limit values in the Directive. The
full report, once completed, is to be submitted for publication
in the Journal of Magnetic Resonance Imaging.
3. The European Commission have funded additional
research intended to complement that funded by HSE. This is due
to report later in 2007.
Activity in Europe
4. The extension, at the UK's instigation,
of the mandate of an existing EMF working group run under the
auspices of the European Commission's statutory Advisory Committee
on Safety and Health at Work to discuss this issue. This tripartite
body has met several times, and has two UK members. It will make
recommendations to the full Committee later in 2007.
5. The European Parliament's Employment
and Social Affairs Committee discussed the matter on 7 May 2007.
This has the effect of raising the profile of the issue, with
many more Member States becoming concerned. This has resulted
in a number of actions by the European Commission, culminating
in two letters, in March and July, from the Director General for
Employment and Social Affairs, to all Member States, giving a
commitment to take appropriate steps. The EC have indicated they
may propose a delay to the transposition deadline for the Directive,
perhaps by two to four years, to enable an appropriate solution
to be found.
6. The European Society of Radiology has
organised an "alliance for MRI" which includes around
50 MEPs.
7. The International Commission on Non-Ionizing
Radiation Protection (ICNIRP) is reviewing some of the limits,
which underpin the Directive.
CONSULTATION (60
AND 70)
8. HSE published new internal guidance on
consulting stakeholders in March 2007. The document links directly
to the Better Regulation Executive's guidance and Code of Practice
on Consultation so that HSE's approach is consistent with that
of other government departments. The opportunity was taken to
re-emphasise a few key points, particularly in the light of lessons
learnt from the House of Commons Science and Technology Select
Committee report:
(a) The importance of early external consultation
on the basis of a full stakeholder analysis beyond the customary
consultees.
(b) The need to comply with the Chief Scientific
Adviser's Guidelines and involve the Chief Scientist in scientific
dossiers, especially if there is conflicting scientific advice.
(c) The desirability of talking to stakeholders
(for example SMEs or professional groups) in addition to the more
usual written/internet consultations.
(d) How HSE reports the results of consultation.
(e) How to handle disagreements with stakeholders
and the importance of flagging these up within HSE and HSC, and
making it clear to stakeholders that they can escalate their case.
9. The new guidance has been actively promoted
throughout HSE, with training for all key staff likely to be engaged
in similar consultations.
10. The Interdepartmental Liaison Group
on Non-ionising Radiation (IDLG NIR) has no executive powers but
functions as a means of raising awareness of NIR and electromagnetic
fields (EMF) issues that might affect policy. Following the Select
Committee report, members the IDLG considered in December 2006
how to review and strengthen its approach. Rather than add more
members to its ranks, they chose to consult more widely within
their own organisations and include horizon scanning as apart
of this consultation. In this way members of the IDLG should therefore
be more alert to the various needs of the other parts of their
complex organisations as and when issues arise.
MANAGEMENT OVERSIGHT
OF EUROPEAN
NEGOTIATIONS (61)
11. New procedures have been put in place
to improve the management oversight of all European negotiations,
and this is already reaping rewards with better co-ordination
within HSE and across Government. This new oversight involves
regular senior level reviews of all proposals and, in some instances,
the use of senior-level project boards chaired by a HSE Director.
These address questions such as the adequacy of plans for stakeholder
engagement and consultation, the proper resourcing to ensure the
right balance of policy and specialist input, potential difficulties
and how can they be avoided, and how the Health and Safety Commission
(HSC), Ministers and Parliament will be involved.
ROLE OF
THE HSE AND
DEPARTMENT OF
HEALTH (DH) CHIEF
SCIENTIFIC ADVISORS
AND MAKING
BEST USE
OF SCIENCE
(40, 54, 60)
12. HSE's new Chief Scientific Advisor (CSA),
Patrick McDonald, has been instrumental in taking forward a "Making
Best Use of Science" project. There are three key strands
of this work which relate to the findings of the Select Committee.
The first is the establishment of a core Science and Technology
Group which will bring together expertise from within HSE and
the Health and Safety Laboratory (HSL). This will help to ensure
that HSE can respond to new and emerging risks in a more co-ordinated
and coherent manner; the second is the establishment of two senior
scientific advisors to work directly to the CSA with a remit to
ensure that HSE's scientific resource meets the current and future
challenges of a changing work place; the third is the establishment
of a more rigorous and longer term methodology for science planning,
which will involve input from HSE's horizon scanning team, and
the establishment of an HSE Board Science Sub Group, including
external representatives, chaired by the CSA.
13. HSE has recognised the need to ensure
that both policy makers and scientists understand the requirement
for sound, underpinning evidence when formulating new policy.
A series of workshops have been run and more are planned, which
bring together policy makers and scientists with the aim of developing
a mutual understanding of needs and constraints of each party.
These have been very well received and a recent external review
by Environmental Research Funders' Forum (ERFF) commented on their
value.
14. The scientific responsibilities in the
Department of Health (DH) are three-fold: The DH Chief Scientist
is Dr David Harper, the Chief Scientific Adviser is Professor
Sally Davies and the Chief Scientific Officer is Professor Sue
Hill (NHS Healthcare Science). All three have an interest in the
issues identified by the Select Committee recommendations on MRI
and the Physical Agents (EMF) Directive and will be kept informed
of such cross-boundary issues. Since the Select Committee report
was published, the DH Chief Scientist has met with the CSA at
the HSE.
REGULATORY IMPACT
ASSESSMENTS (PARAGRAPH
32)
15. There have been a number of changes
to Regulatory Impact Assessments, now called Impact Assessment
(IA), procedures in central government and HSE. They include the
need for the Chief Economist to provide a submission to the HSE's
Chief Executive or HSC's Chair which will need to clarify that
the analysis is of sufficiently high standards, a number of additional
tests which will be integrated in the IA as and when needed and
the attempt to start the IA process as early as possible to ensure
a full reflection of all impacts and the scope for the IA to influence
policy making.
16. In May 2007, the Better Regulation Executive
introduced new guidance and an electronic toolkit on when Impact
Assessments need to be produced by government departments. HSE
formally agreed the introduction of these new guidelines at Board
level, and promulgated them through a message to staff and through
new better policy making seminars. These seminars, aimed at policy
staff, focus on the importance of developing good Impact Assessments
through all stages of policy development. They also reinforce,
for those involved in EU negotiations, the need to have a well-developed
Impact Assessment available prior to the start of EU negotiations
and amended, as necessary, to take account of changes to the EU
proposal during negotiations.
17. HSE has also established a Challenge
Panel whose operating criteria include supporting effective handling
of emerging EU proposals. In line with UK EU policy, HSE is pressing
the European Commission (EC) to honour its commitment in "Better
Regulation for Growth and Jobs in the European Union" COM(2005)
97 final, to produce good quality Impact Assessments for significant
proposals. When produced, HSE's negotiators are instructed to
challenge poor quality assessments.
October 2007
|