Watching the directives : scientific advice on the EU Physical Agents (Electromagnetic Fields) Directive : fourth report of session 2005-06 : report, together with formal minutes, oral and written evidence / House of Commons, Science and Technology Committee.

  • Great Britain. Parliament. House of Commons. Select Committee on Science and Technology.
Date:
2006
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Licence: Open Government Licence

Credit: Watching the directives : scientific advice on the EU Physical Agents (Electromagnetic Fields) Directive : fourth report of session 2005-06 : report, together with formal minutes, oral and written evidence / House of Commons, Science and Technology Committee. Source: Wellcome Collection.

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    5.1.4 The HSE should have drawn on more diverse sources of advice, to both supplement and aid in interpretation of the HPA guidelines. The UK has extensive expertise in MRI, including safety aspects. Unfortunately the HSE declined to give due weight to this expertise until the matter was raised in the press and the responsible minister became involved personally. 5.2 Treatment of Risk 5.2.1 In our opinion the derivation of exposure limits from sparse evidence in the ICNIRP guidelines is manifestly precautionary, in that “potentially dangerous effects . . . have been identified, and . . . scientific evaluation does not allow the risk to be determined with sufficient certainty”.!' Therefore, application of these guidelines in the EU should be guided, inter alia, by proportionality and cost-benefit analysis. Both economic and non-economic aspects of cost-benefit assessment are necessarily specific to a given setting: the considerations appropriate to medical MRI are likely to differ from those relevant to, for example, the telecommunications industry. However, the limits are not presented in the Directive as precautionary values, but as established thresholds for onset of adverse effects. 5.2.2 The HPA advice uses the term “caution” when assessing uncertain scientific data that inform the numerical limits, and “precaution” only in respect of possible further measures related to long-term effects of exposure.'* However, we maintain that the HPA’s adoption of numerical limits is precautionary according to the EU definition. It is based on a key assumption about central nervous system function described in the literature as being appropriate if one wished to adopt “a precautionary principle.” !* 5.2.3 These inconsistencies in terminology, and failure to understand the status of scientific evidence and of guidelines derived from it, led HSE to believe that exposure limits were necessary to protect the health of workers, whereas there is no positive evidence to this effect. 5.2.4 Given this belief, regulators were unwilling or unable to consider the fact that prohibiting some MRI practices would lead to increased radiation risk to staff. 5.2.5 Exclusion of patient risk from ionising radiation from consideration in the context of occupational exposure is of particular concern: medical staff routinely bear risk in order to provide healthcare. If this were not accepted, then X-ray imaging and certainly X-ray guided intervention would have to be prohibited. 5.3 Transparency, Communication and Public Engagement 5.3.1 Communication between the MR community and the HSE during passage of the Directive was poor, and there was no input to negotiations at European level. We were told that the HSE was bound by HPA and ICNIRP advice, and that scanner design and clinical practice would simply have to change to accommodate the Directive. 5.3.2 This is in marked contrast to the experience of the medical imaging community during negotiation of Directives relating to ionising radiation, where meaningful dialogue resulted in sensible legislation. 5.3.3 The MR community is now working with the HSE to try to solve the problems that have arisen. We are grateful to Lord Hunt and to senior HSE policy staff for their constructive and open approach. We believe that better consultation earlier in the process could have influenced the UK’s position and hence the content of the Directive. It should not have been necessary for the community to go to the press and escalate matters to ministerial level in order to be taken seriously by the HSE. 5.4 Evaluation and Follow-up 5.4.1 Most of the scientific data that informed the ICNIRP guidelines had been peer reviewed. The HPA literature review in 2004 is widely regarded as a definitive summary of the state of the science. However, it is not clear that the process of sifting evidence and theoretical speculation in order to develop exposure limits has been subject to equally rigorous evaluation. The leap from cautious, guarded statements in the ICNIRP guidelines to “known . . . adverse health effects” in the Directive would certainly not have survived objective scientific review. 6. RECOMMENDATIONS FOR THE COMMITTEE TO CONSIDER — 6.1 The government should consider whether it is appropriate for the same agency, and indeed the same small group of individuals within it, to have responsibility for consultation, negotiation, implementation and enforcement of legislation. In this situation it is easy for views to become entrenched and for other interests to be excluded from meaningful participation. — 6.2 Government agencies should draw more widely on the expertise of professional bodies and funding bodies (public, charitable and commercial) to develop a clearer understanding of the implications of legislative proposals. Meaningful consultation with these bodies should be a statutory requirement when UK representatives are formulating positions for negotiation at European level. f '' Commission of the European Communities (2000) Communication from the Commission on the Precautionary Principle. http://europa.eu.int/comm/dgs/health_consumer/library/pub/pub07_en.pdf '2 NRPB (2004) Documents of the NRPB Vol 15 (3) p 210. 'S Attwell D (2003) Radiat Prot Dosim 106 341-348.