Directive for the protection of workers from exposure to electro-magnetic fields and waves (EMF)

The EU have just released this statement on the progress of negotiations:
 
'Static Magnetic Fields (and implications for magnetic resonance imaging (MRI)
 
Static Magnetic Fields have been removed from the exposure limit values but there will still be a requirement to undertake a risk assessment at the Action levels according to Table 2.
 
This is because the Council feels that it is not yet possible to address the health effects resulting from occupational exposure to static magnetic fields while there are still uncertainties in existing knowledge. An updated review of the scientific evidence has not yet been completed but the International Commission for Non Ionising Radiation Protection (ICNIRP) are currently undertaking work to address these issues and developments will be monitored. This could eventually lead to amending the Directive.'
 
This means that there are now no plans to limit exposure to static magnetic fields in the short term. Thank you to everyone who helped to raise the profile of this problem and to ICNIRP. It did also highlight the continuing need for human research in this field.
 
However, it does set an exposure level for current density 40 mA/m2 rms.

Proceedings from the Council of the European Union, 17-18 September 2003

Amended proposal for a Directive of the European Parliament and of the Council on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields and waves) - Update on Negotiations - September 2003

On this page:

1. The directive
   • History
   • Time scale
   • Exposure limits and Action values
2. Who to contact
3. The ISMRM position
4. The FDA position
5. Other organizations with a view on this matter
6. References and other documents related to safety

The directive

History

Some versions of the Draft document are linked here:

• 10th December 2002
• 23 May 2003.
• Records of discussions July 2003 Comments, Minutes

The proposed limits are based on International Commission on Non-Ionizing Radiation Protection (ICNIRP) [1,2] guidelines (although there are apparently some important deviations from ICNRIP concepts). As we understand it, the ICNIRP guidlines were closely linked to UK NRPB guidelines [3,4]. The ICNIRP is currently preparing a statement on MRI, but it is unfortunately confidential at this stage. The UK National Radiological Protection Board (NRPB) is has a published a consultation document on its existing guidelines, proposing no change, and have said that they will continue to take comments on it passed the date for final date for comments that they mention, which is the 28th July.

Time scale:

This directive is currently being discussed by the member states, and apparently the Italian presidency is keen to complete the discussions during its term. It is possible that member states will reach a common position by the end of the year (although this is the earliest that this may occur). The directive will then have to be read and passed by the European Parliament. If the Parliament passes this into law, the Directive will then have to be adopted into local law by member states within 3 years.

Exposure limits and Action values

The directive defines two sets of values. The following statements are shortened qutoes from the text:

• Exposure limit values: Limits to exposure to EMFs which are based on established health effects and biological considerations. Compliance with these limites will ensure the workers are protected against known adverse health effects.
• Action values: The magnitude of directly measurable parameters (E,H,B etc) at which one or more specified measures in the Directive must be undertaken. Compliance with these values will ensure compliance with the exposure limits.

Action Values

Who to contact:

Whilst the Directive is still being discussed, you should send any comments that you have

1. Most importantly on the science being used to establish these limits since the EU rather have their hands tied by the advice they are getting from their scientific advisors.
   • ICNRIP: They are currently revising their exposure limits. If the new document is put out for consultation we will inform you here.
   • NRPB (UK) They recently published a consultation document on this matter.
   • Please let me know the appropriate organizations for other member states
     • Copies of letters sent to national regulatory bodies: UK NRPB(BIR)
2. On the directive to (they are meeting again on the 4th September)
   • Your national negotiators
   • Appropriate members of the Council of the EU (please let me know of any changes)
   • Appropriate ministers in your own government. (In the UK individuals will have most impact by writing to their MP and asking them to raise the matter with the Secretaries of State for Industry (re. magnets), Health and Europe). Please let me know the situation elsewhere in Europe.
     • Copies of some letters that have already been sent to national negotiators are available here:
       • UK(BIR).
       • Memos prepared by MR manufacturers, highlighting the huge benefits of MRI to society and the affects of the proposed directive. First Second
3. The EU Commission: The European Agency for Health and Safety at Work
   • Reply from the EU to the ESMRMB

If the Directive reaches the EU parliament, we will email you again to let you know. At that point you may wish to contact your MEP. As far as I can see, there is little point in contact MEPs yet..

We suggest that you send you letters by post (not email) and ask for them to be acknowleged.

ISMRM position:

ISMRM statement.

FDA position:

The FDA only deals with exposure of patients (not staff) in the USA, but it is interesting to note that they have recently published on this matter, and have just increased their 'significant risk level' from 4 T to 8 T for adults (and to 4T for neonates).

Other organizations with an interest in this matter:

• European Agency for Health and Safety at Work
• Metal trade organizations: WEM and Orgalime: Their joint statement
• Society for Radiation Protection
• Health and Safety Commission
• COCIR, the European Coordination Committee of the Radiological, Electromedical and Medical Information Technology Industries: Letter, Paper Memo First, Memo Second

References and other documents related to safety:

1. Guidelines on limits of exposure to static magnetic fields, International Commission on Non-ionizing Radiation Protection. Health Physics, 66, 1, 100-106, 1994. Page 1 2 3 4 5 6 7
2. Guidelines on limiting exposure to time varying electric, magentic and electromagnetic fields (up to 300 GHz). International Commission on Non-ionizing Radiation Protection. Health Physics, 74, 4, 494-522, 1998.
3. National Radiological Protection Board statement on Clinical Magnetic Resonance Diagnostic Procedures, 2, 1, 1991 (Chilton, Didcot, Oxon, OX11 0RQ)
4. National Radiological Protection Board statement on Restriction of Human Exposure to Static and Time Varying Electromagnetic Fields and Radiation, 4, 5, 1993 (Chilton, Didcot, Oxon, OX11 0RQ)
5. IEC EN 60601-2-33: MEDICAL ELECTRICAL EQUIPMENT - Particular requirements for the safety of magnetic resonance equipment for medical diagnosis. (It does not contain any occupational limits).
6. American College of Radiology White Paper on MR Safety, Kanal et al, AJR, 176, 1335-1347, 2002.
7. Guidelines for Magnetic Resonance Equipment in Clinical Use. Medical Devices Agency, UK, December 2002.
8. Schenck, Safety of strong, static magnetic fields. JMRI, 12, 2-19, 2000.

Comments on this page to penny.gowland@nottingham.ac.uk. Last updated 23 July 2003.