HSE working party on MRI and Physical Agents Directive: Notes of meeting held on 8 November 2006 Sense About Science site

Government and Health Protection Agency responses to Science and Technology Committee report Watching the Directives:Scientific Advice on the EU Physical Agents (Electromagnetic Fields) Directive (pdf 140KB) 24 October 2006 full report Parliament site:

Extracts from the Government response

• UK negotiating lines were informed by consultation with stakeholders,as is normal,but HSE recognises that,on this occasion,it was inadequate.
• Whilst it is true that the existing guidelines were considered sufficient, the Directive is not expected to impose significant burdens on employers who are already complying with them.
• It is important to recognise that the discussions within the UK aimed to engage the MRI community,principally, to explore the consequences of the removal of the static field values, and help the MRI community and others identify solutions in relation to more generic duties under existing health and safety legislation,in particular the need to conduct or review risk assessments in the light of technological developments. Nevertheless, it is clear that HSE ’s approach in these circumstances was not sufficiently transparent and consequently its policy position was not perceived correctly or consistently.
• HSE is committed to evidence-based policymaking supported by the best available scientific advice, including that of its in-house experts and external expertise. It has put in place a quality system to secure effective implementation of the Chief Scientific Adviser’s Guidelines including guidance on how to resolve conflicting scientific opinion. Reviews undertaken to date show good compliance with this guidance but the review programme will be broadened and strengthened in the light of the Committee’s findings,and HSE will urgently review its performance across a range of the Directives that it is negotiating or implementing.
• The Government believe the precautionary principle is valuable in dealing with uncertainty. There is no single definition for the Precautionary Principle. However,in the context of the Treasury’s guidance The Green Book: Appraisal and Evaluation in Central Government it is defined as, 'The concept that precautionary action can be taken to mitigate a perceived risk.Action may be justified even if the probability of that risk occurring is small,because the outcome might be very adverse'. In practice the Precautionary Principle is interpreted as a flexible precautionary approach to enable innovation and learning in circumstances of significant complexity and uncertainty. As such, the supplement to The Green Book Managing risks to the public:appraisal guidance advises that precautionary approaches should be adopted alongside research and monitoring, and that highly restrictive or expensive precautionary interventions should be reviewed on a regular basis in the light of research findings and new data.
• HSE recognises that,although efforts were made to engage with all stakeholders,in one area,it did not succeed in properly reflecting their needs.It acknowledges the need to review the way in which it consults and whether it is seen by those consulted to have properly considered their views.HSE has already started a review of its internal consultation procedures.This will be brought to a conclusion this autumn,with new internal guidance linked to new Cabinet Office best practice guidance. In the interim,HSE’s web-based guidance on handling EU negotiations is being amplified to bring out the headline points for EU negotiators. For its part, the Health Protection Agency (HPA, formerly NRPB) has already posted on its web site a response to the issues raised and has said it will study the points made by the Committee carefully and ensure that any lessons are learnt from this episode.

Watching the Directives: Scientific Advice on the EU Physical Agents (Electromagnetic Fields) Directive - House of Commons Science and Technology Committee (pdf 2,400KB) 29 June 2006 full report Parliament site:

• failings in the way that scientific advice was used to inform the Directive
• not a strong enough case for a Directive covering MRI
• in the UK serious failings in the consultation process
• HSE was giving information on its policy in the UK that was in flat contradiction to the line it had been pursuing in Brussels
• slow reaction of the MR community to the full potential impact of the Directive
• suggested improvements to the way in which the Government and scientific communities can interact on European legislation.
• no clear evidence as to how the precautionary principle was applied, nor any satisfactory definition of the principle or explanation of how it should be applied

The following summary is taken from the Parliament site, accessed 12 July 2006.

House of Commons Science and Technology Committee Watching the Directives: Scientific Advice on the EU Physical Agents (Electromagnetic Fields) Directive Fourth Report of Session 2005 –06 Published on 29 June 2006 Summary This Report is the first of three case studies under the Committee’s over-arching inquiry into how Government handles scientific advice, evidence and risk in policy making. We examined this subject to test the way in which scientific advice is used by the UK Government to influence policy at an EU level, and also in response to concerns from the medical research community about the potential impact of this Directive on the use of Magnetic Resonance Imaging (MRI) equipment for diagnosis, treatment and research. The Committee has discovered failings in the way that scientific advice was used to inform the EU Physical Agents (Electromagnetic Fields) Directive, both in Brussels and in the UK. We found that the Commission was heavily reliant on one source of advice, the International Commission on Non-Ionising Radiation Protection (ICNIRP), and was not sufficiently responsive to concerns raised by the magnetic resonance community. As a result, it is deeply regrettable that the research necessary to establish whether or not the Directive will inhibit the use of MRI scanners is only now being carried out, with a risk that it will not be complete in time to inform the implementation of the Directive, due by 2008. On the basis of the level of certainty in the available scientific evidence, we agree with the Government that there was not a strong enough case for a Directive covering MRI: existing guidelines are sufficient. In the UK we identify serious failings in the consultation process. In particular, we are critical of the highly disappointing response of the Health and Safety Executive and the Health Protection Agency to the concerns expressed by the magnetic resonance community about the potential impact of the Directive. This response was characterised by an instinctive and dismissive resistance rather than an attempt to engage and examine. We also find it extremely worrying that the Health and Safety Executive was giving information on its policy in the UK that was in flat contradiction to the line it had been pursuing in negotiations in Brussels. The weaknesses of the consultation process were exacerbated by the slow reaction of the magnetic resonance community to the full potential impact of the Directive and by failings in the horizon scanning activities of Government and the Research Councils. We have suggested improvements to the way in which the Government and scientific communities can interact on European legislation. Finally, we used this case study as an opportunity to examine how the precautionary principle is applied in practice. Unfortunately, we found no clear evidence as to how it was applied in the context of this Directive, nor any satisfactory definition of the principle or explanation of how it should be applied.

Notes of meeting on Physical Agents Directive - EM Fields, 27 July 2004 HSE site
Directive 2004/40/EC on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) - Notes of Open Consultation Meeting, HSE, Rose Court, London, 27 July 2004

European Physical Agents Directive on Electromagnetic Fields full text pdf EU site

Physical Agents Directive - Electromagnetic Fields - Industry Meeting to be held on 27 July 2004 Subject: Physical Agents Directive - Electromagnetic Fields - Industry Meeting to be held on 27 July 2004 To: [...] admin@srp-uk.org [...] From: Tarla.Patel@hse.gsi.gov.uk Date: Tue, 1 Jun 2004 11:24:10 +0100 STATUS: FOR INFORMATION AND ACTION BY 21 JUNE 2004 Dear all European Commission proposal for a Council Directive on the minimum health and safety requirement regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields). 1. You will be aware that this Directive was adopted in April and we now have four years in which to introduce new regulations.  We are very keen to take forward the process of implementation jointly with industry and have therefore arranged a meeting on Tuesday 27 July 2004 at 2:00 pm in the Rose/Globe Rooms, Rose Court, 2 Southwark Bridge, London SE1 9HS - an agenda and directions to Rose Court are attached. Please note we expect the meeting to finish by 4:30pm. 2. I would be grateful if you could let me know  whether you will be attending the meeting by no later than Monday 21 June 2004. 3. Please note the Council Directive was published in the Official Journal on 30 April 2004 (copy attached), it appeared as L 159 but was withdrawn because of errors, however, some of those errors have now been corrected and was republished as L 184. (See attached file: Stakeholder meeting 27 July 2004.doc [download Word]) (See attached file: rose_court_london.pdf [download pdf]) (See attached file: EMF official journal may 2004.pdf [download pdf]) Many thanks Tarla Patel Health and Safety Executive Physical Agents Policy Unit (HTPD2) Rose Court 6th Floor, North Wing 2 Southwark Bridge London SE1 9HS Tel: 0207 717 6976 Fax: 0207 717 6199 e:mail: tarla.patel@hse.gsi.gov.uk ********************************************************************************* Interested in Occupational health and safety information? Please visit the HSE website at the following address to keep yourself up to date. www.hse.gov.uk *********************************************************************************

Review of the Scientific Evidence for Limiting Exposure to Electromagnetic Fields (0–300 GHz) NRPB site
Doc. NRPB 15 (3) 2004. ISBN 0-85951-533-8

Advice on Limiting Exposure to Electromagnetic Fields (0–300 GHz) NRPB site
Doc. NRPB 15 (2) 2004. ISBN 0-85951-532-X.

NRPB report - ELF Electromagnetic Fields and the Risk of Cancer - Report of an advisory group, chairman Sir Richard Doll
The following information, including the conclusions and recommendations for research, is taken from the NRPB web site at http://www.nrpb.org.uk accessed 6 March 2001.

Documents of the NRPB Volume 12 No 1 2001 ELF Electromagnetic Fields and the Risk of Cancer Report of an Advisory Group on Non-ionising Radiation This report reflects understanding and evaluation of the current scientific evidence as presented and referenced in the full document. CONTENTS ELF Electromagnetic Fields and the Risk of Cancer Report of an Advisory Group on Non-ionising Radiation Advisory Group on Non-ionising Radiation 1 Introduction References 2 ELF Electric and Magnetic Fields: Sources and Measurements Introduction Exposure assessment Exposure to ELF fields Summary References 3 Recent Cellular Studies Relevant to Carcinogenesis Introduction Initiation Promotion or alteration of cellular processes which could affect the mechanisms leading to cancer Summary Conclusions References 4 Recent Animal and Volunteer Studies Relevant to Carcinogenesis Introduction In vivo studies of mutagenesis Animal tumour studies Melatonin, cancer and electromagnetic fields Immune system responses relevant to cancer Conclusions References 5 Recent Epidemiological Studies on Residential Electric and Magnetic Fields and Cancer Introduction Studies of leukaemia and other malignancies in children Other studies of children specifically limited to CNS tumours Studies of cancer in adults Appliance use Miscellaneous studies Commentary Overviews Case-specular method Conclusions References 6 Occupational Exposure to Time-varying ELF Electric and Magnetic Fields and Cancer Introduction Studies lacking personal exposure measurements Studies with quantitative estimates of personal exposures Methodological issues Discussion Conclusions References 7 Conclusions Exposure assessment Cellular studies Animal and volunteer studies Residential exposure Occupational exposure General conclusion 8 Recommendations for Research Experimental studies Epidemiological studies Appendix – Incidence of Neoplasia in Life-time Animal Studies References Glossary ADVISORY GROUP ON NON-IONISING RADIATION CHAIRMAN Sir Richard Doll, Imperial Cancer Research Fund Cancer Studies Unit, Oxford MEMBERS Professor C Blakemore, University of Oxford Professor E H Grant, Microwave Consultants Limited, London Professor D G Harnden, Wythenshawe Hospital, Manchester Professor J M Harrington, Institute of Occupational Health, Birmingham Professor T W Meade, St Bartholomew's and Royal London School of Medicine Professor A J Swerdlow, Institute of Cancer Research, London SECRETARIAT Dr R D Saunders, National Radiological Protection Board, Chilton OBSERVER Dr H Walker, Department of Health, London ASSESSORS Dr A F McKinlay, National Radiological Protection Board, Chilton Dr C R Muirhead, National Radiological Protection Board, Chilton Dr J W Stather, National Radiological Protection Board, Chilton CONSULTANT Mr S G Allen, National Radiological Protection Board, Chilton Please note that the paragraph numbering from the full published document has been retained in the chapters below. CONCLUSIONS (Chapter 7) 1 The Advisory Group provides in this report a comprehensive review of experimental and epidemiological studies relevant to an assessment of the possible risk of cancer resulting from exposures to power frequency (extremely low frequency, ELF) electromagnetic fields (EMFs) that have been published since its first report in 1992. It is not concerned with exposures to high frequencies nor with other potential effects of exposure to power frequencies. The possibility of an association between neurological diseases, such as Alzheimer's disease, and magnetic field exposure is being considered separately. The report summarises the extent of exposure to power frequency electromagnetic fields at home and at work and reviews recent epidemiological investigations of cancer incidence in humans. It also reviews recently published cellular, animal and human volunteer studies. EXPOSURE ASSESSMENT 2 Studies reviewed in the earlier report by the Advisory Group suffered from a lack of measurement-based exposure assessments. Since then, considerable advances have been made in methods for assessing exposure, both in the case of experimental studies and in epidemiological investigations. Instrumentation allowing personal exposure to be measured has become widely available and has been used in many of the more recently published studies. This has provided a substantially improved basis for many of the epidemiological studies reviewed by the Group. CELLULAR STUDIES 3 At the cellular level, there is no clear evidence that exposure to power frequency electromagnetic fields at levels that are likely to be encountered can affect biological processes. Studies are often contradictory and there is a lack of confirmation of positive results from different laboratories using the same experimental conditions. There is no convincing evidence that exposure to such fields is directly genotoxic nor that it can bring about the transformation of cells in culture and it is therefore unlikely to initiate carcinogenesis. 4 The most suggestive evidence of an effect of exposure to power frequency magnetic fields on biological systems comes from three different areas: possible enhancement of genetic change caused by known genotoxic agents, effects on intracellular signalling, especially calcium flux, effects on specific gene expression. . 5 Those results that are claimed to demonstrate a positive effect of exposure to power frequency magnetic fields tend to show only small changes, the biological consequences of which are not clear. 6 Many of the positive effects reported involve exposure to time-averaged fields greater than 100 µT which are unlikely to be encountered in a domestic situation where typical exposures generally fall in the range between 10 and 200 nT. It is usual to test carcinogens at levels well above those normally encountered in order to demonstrate their potential to have an effect, on the assumption of a linear dose–response relationship without threshold. However, such an assumption may not be justified with non-genotoxic agents and risk assessment is most usefully focused on realistic exposure levels. Furthermore, the induced current density may be radically different in vivo as compared with that for cells in culture. ANIMAL AND VOLUNTEER STUDIES 7 Overall, no convincing evidence was seen from a review of a large number of animal studies to support the hypothesis that exposure to power frequency electro-magnetic fields increases the risk of cancer. 8 Rodents, particularly mice, have been used extensively in studies of adult leukaemogenesis; there is, however, currently no natural animal model of the most common form of childhood leukaemia, acute lymphoblastic leukaemia. Most studies report a lack of effect of power frequency magnetic fields on leukaemia or lymphoma in rodents, mostly mice. These include several recent large-scale studies of spontaneous tumour incidence in normal and transgenic mice, and of radiation-induced lymphoma and leukaemia in mice. The transgenic mice used in two of the studies mentioned above develop a disease with some similarities to childhood acute lymphoblastic leukaemia. Further studies found no effect on the progression of transplanted leukaemia cells in mice or rats. 9 Rat mammary carcinomas represent a standard laboratory animal model in the study of human breast cancer. Three recent large-scale studies of rats found that lifetime magnetic field exposure had no effect on the incidence of spontaneous mammary tumours. The evidence concerning electromagnetic field effects on chemically induced mammary tumours is more equivocal. Two early studies suggested that exposure to power frequency magnetic fields increased the incidence or growth of chemically induced mammary tumours in female rats but two more recent studies have not corroborated these findings. 10 Whilst there is no natural animal model of spontaneous brain tumour, a recent large-scale study reported a lack of effect of exposure to power frequency magnetic fields on chemically induced nervous system tumours in female rats. In addition, the low incidence of brain cancers in three recent large-scale rat studies was not elevated by magnetic field exposure. With regard to studies of other tumours, particularly chemically induced skin tumours, the evidence is almost uniformly negative. 11 The possibility that the hormone melatonin acts as a natural tumour suppressor is controversial. Nevertheless, a number of studies have investigated the ability of power frequency electromagnetic fields to alter endogenous circadian melatonin rhythms. Most evidence from human volunteer studies suggests that melatonin rhythms are not delayed or suppressed by exposure to power frequency magnetic fields, although one recent study provided preliminary data indicating that exposure prior to the night-time rise in serum melatonin may have had this effect in a sensitive subgroup of the study population. In addition, the evidence for an effect of exposure to power frequency magnetic fields on melatonin levels and on melatonin-dependent reproductive status in seasonally breeding animals is largely negative. The evidence concerning power frequency electromagnetic field induced suppression of rat pineal and/or serum melatonin levels is equivocal and the physiological relevance of any effect (if any is produced) remains unclear. 12 There is no consistent evidence of any inhibitory effect of power frequency magnetic field exposure on those aspects of immune system function relevant to tumour suppression that have been examined. In addition, two studies were unable to correlate possible electromagnetic field induced changes in tumour incidence with significant changes in immune function. RESIDENTIAL EXPOSURE 13 Recent large and well-conducted studies have provided better evidence than was available in the past on the relationship between power frequency magnetic field exposure and the risk of cancer. Taken in conjunction they suggest that relatively heavy average exposures of 0.4 µT or more are associated with a doubling of the risk of leukaemia in children under 15 years of age. The evidence is, however, not conclusive. In those studies in which measurements were made, the extent to which the more heavily exposed children were representative is in doubt, while in those in Nordic countries in which representativeness is assured, the fields were estimated and the results based on such small numbers that the findings could have been due to chance. In the UK, very few children (perhaps 4 in 1000) are exposed to 0.4 µT or more and a study in the UK, with much the largest number of direct measurements of exposure, found no evidence of risk at lower levels. Nevertheless, the possibility remains that high and prolonged time-weighted average exposure to power frequency magnetic fields can increase the risk of leukaemia in children. Data on brain tumours come from some of the studies also investigating leukaemia and from others concerned exclusively with these tumours. They provide no comparable evidence of an association. There have been many fewer studies in adults. There is no reason to believe that residential exposure to electromagnetic fields is involved in the development of leukaemia or brain tumours in adults. OCCUPATIONAL EXPOSURE 14 Study of populations exposed occupationally to electromagnetic fields can include groups exposed generally at much higher levels than members of the public. They may therefore have a greater potential to detect any adverse health effects. Although recently published studies of occupational exposure to electromagnetic fields and the risk of cancer are, in the main, methodologically sound, and some of them have considerable statistical power, causal relationships between such exposure and an increase in tumour incidence at any site are not established. The excesses, where they exist, are generally modest and are largely restricted to the two cancers that were noted in the 1992 report of the Advisory Group – that is, leukaemia and cancer of the brain. Conflicting evidence exists for the particular cell types of leukaemia associated with the greatest risk but acute myeloid leukaemia is the most cited. The evidence of any risk for brain cancer is conflicting, even that from the most powerful of the studies. GENERAL CONCLUSION 15 Laboratory experiments have provided no good evidence that extremely low frequency electromagnetic fields are capable of producing cancer, nor do human epidemiological studies suggest that they cause cancer in general. There is, however, some epidemiological evidence that prolonged exposure to higher levels of power frequency magnetic fields is associated with a small risk of leukaemia in children. In practice, such levels of exposure are seldom encountered by the general public in the UK. In the absence of clear evidence of a carcinogenic effect in adults, or of a plausible explanation from experiments on animals or isolated cells, the epidemiological evidence is currently not strong enough to justify a firm conclusion that such fields cause leukaemia in children. Unless, however, further research indicates that the finding is due to chance or some currently unrecognised artefact, the possibility remains that intense and prolonged exposures to magnetic fields can increase the risk of leukaemia in children. RECOMMENDATIONS FOR RESEARCH (Chapter 8) 1 The Advisory Group recognises that the scientific evidence suggesting that exposure to power frequency electromagnetic fields poses an increased risk of cancer is very weak. Virtually all of the cellular, animal and human laboratory evidence provides no support for an increased risk of cancer incidence following such exposure to power frequencies, although sporadic positive findings have been reported. In addition, the epidemiological evidence is, at best, weak. Nevertheless, considering the ubiquitous nature of power frequency electromagnetic field exposure and the concern about possible adverse health effects, the Advisory Group considers that the following areas of research merit further investigation. EXPERIMENTAL STUDIES 2 Further biophysical studies might suggest conditions of exposure more liable to affect carcinogenic processes. Particular attention should be given to weak magnetic field effects on biochemical processes involving radical pair intermediates. Consideration should also be given to the possibility that exposure parameters such as the higher frequencies associated with switching transients might be more biologically relevant than experimental data based only on the time-weighted average exposure. Additional dosimetric studies are required using improved tissue conductivity data in order to quantify more accurately the magnitude and distribution of induced current in the body. Consideration needs also to be given to the possible effects that might result from the dispersal of corona ions and the way any such effect might be assessed. 3 At the cellular level, further studies should be carried out of possible enhancement of genetic change caused by known genotoxic agents, effects on intracellular signalling and effects on specific gene expression. These studies should focus, where possible or appropriate, on the replication of studies that have previously suggested positive results. 4 For animal carcinogenesis studies, future work should be based on carefully designed, hypothesis-driven investigations. Such hypotheses may be derived from consideration of mechanistic investigations at the cellular level and epidemiological investigations. With regard to the epidemiological observations concerning possible increased risks of childhood acute lymphoblastic leukaemia, the absence of a natural animal model has imposed significant restrictions on experimentation. However, there are various transgenic mouse models of leukaemia which develop a disease having some similarities to childhood acute lymphoblastic leukaemia which may prove useful in future studies. It would in addition be valuable to study possible power frequency effects on the cellular structure and development of the prenatal and neonatal haemopoietic system and any implications for cellular differentiation and clonal growth. There is no strong epidemiological or experimental evidence concerning increased risks of brain or mammary tumours and therefore there is less imperative for further study. However, a recently developed model of spontaneous medulloblastoma in Ptch-knockout mice and, more particularly, a mouse model of astrocytomas, a leading cause of brain cancer in humans, may prove useful in the investigation of electro-magnetic field effects on spontaneous brain tumour incidence. In addition, further investigation should resolve present uncertainties concerning possible electromagnetic field effects on chemically induced mammary tumours. 5 With regard to possible effects on circulating melatonin levels, there is further scope for longer term volunteer studies in the laboratory and volunteer or observational studies in the workplace. However, careful consideration must be given to individual variability in melatonin fluctuation in addition to differences in lifestyle, night-time light exposure and other possible confounding factors. 6 Whilst the evidence concerning possible electromagnetic field effects on the immune system is mostly negative, the effects on tumour rejection per se have not been investigated and further study should be carried out using classical tumour rejection models. EPIDEMIOLOGICAL STUDIES Residential studies 7 Residential studies published to date have mostly been difficult to interpret because of the potential for the control data to be biased. Further work is required to investigate the extent to which the methods of control selection that have been used could have affected the frequency with which relatively high exposures were recorded. 8 Nothing would seem to be gained by further study of more cases of childhood leukaemia in relation to exposure to extremely low frequency electromagnetic fields in the UK, as the number likely to have been exposed to fields of the strength that may cause a material increase in risk (namely fields of 0.4 µT or more) is too small to provide any useful information. There are, however, parts of the European Union, notably Denmark and Sweden, where such exposures are more common and, moreover, where unbiased evidence can be obtained through the use of national registers. It is, therefore, to be hoped that the European Union will fund an extension of the studies that have been reported from the Nordic countries, which alone might provide clear evidence of the existence of a risk (if one does in fact exist). If parts of the world can be identified where yet greater exposures to children occur frequently, and where good quality epidemiological studies are practical, then study of leukaemia risk in relation to electromagnetic field exposures in those places would be valuable. 9 If relatively high residential magnetic fields do not produce a risk directly, it is possible that they might do so in association with some specific (or near specific) alteration in the cell's DNA. It might therefore be helpful to compare the characteristics of the DNA in cases of acute lymphoblastic leukaemia that occurred after exposure to such fields with the DNA in the general run of the disease. Because there would be so few relevant cases in the UK, the research would be worthwhile only with international collaboration. Occupational studies 10 Although occupational studies based on job title suggest a consistent link to excess risks of leukaemia and possible brain tumours, occupational cohort studies have not confirmed this association and are at best equivocal. The more recent cohort studies using better exposure characterisation for magnetic and electric fields either have not shown an association with leukaemia or brain cancer, or the association has been weak. Better quality exposure assessment is needed, preferably with detailed personal records of exposure in large well-characterised cohorts. In addition to cumulative exposure assessments, consideration should be given to the use of metrics such as rate of change of exposure, exposure peaks, duration of exposure above predefined exposure levels and rapid changes in exposure (transients). The paucity of good quality exposure data hampers progress and research within industry is required to correct this deficiency, define the most heavily exposed groups and quantify their exposure. In future cohort studies of exposed workers, note should be taken of the individual's residential history and, when residence had been near a high power transmission line, measurements of exposure at home should also be included. Price £30.00 ISBN 0-85951-456-0