APPENDIX 22
SUPPLEMENTARY EVIDENCE FROM THE HEALTH PROTECTION
AGENCY
QUESTION 1
When ICNIRP first advised the Commission about
the inclusion of (a) static fields and (b) timevarying fields
in the Directive; and what advice was given about the degree of
certainty of the evidence relating to potential adverse health
effects in each case? (Qs 888, 893).
Response—advice
Since the early 1990s, ICNIRP has provided advice
to the European Commission on a variety of subjects including
advice on limiting exposure to static and time-varying fields.
In summary:
— 1990-91—A report (paper) providing
a basis for limiting workers' exposure from physical agents for
DG V. This was a common project of the UK National Radiological
Protection Board (NRPB), the Italian Superior Institute of Health
(ISS) and the German Radiation Protection Agency (BfS). Some of
the members of the writing group were Europeans who were members
of the International Non-Ionizing Radiation Committee (INIRC),
the predecessor body to ICNIRP and the results were published
in the scientific journal "Physica Medica" in 1991 (reference
1).
— 1992-96—Advice on exposure
of the public to NIR for Commission DG V. A report was compiled
by an ad hoc working group comprising scientists from NRPB, BfS
and ISS and was published in 1996. "Non-ionizing Radiation
Sources, Exposure and Health Effects". (reference 2)
— Through the 1990s—Working with
the European Committee for Electrotechnical Standardisation (CENELEC).
CENELEC is mandated to develop technical standards related to
EMF measurements and exposure assessments.
— From 1994—Individual members
of ICNIRP have been variously involved with the project co-operation
in science and technology initiatives COST 244 and COST 244bis
"Biomedical effects of EMF".
— 1996—EC Expert Group, in part
comprising some European ICNIRP members who reviewed the evidence
for possible adverse health effects related to the use of mobile
phones and proposed a European research programme to address the
subject (reference 3).
— 1996-97—ICNIRP European and
other experts to investigate the occurrence of electromagnetic
hypersensitivity for EC DG V (reference 4).
— 1999-2001 Concerted Action—Possible
Health Risks to the General Public from the Use of Security and
Similar Devices—for EC DG XIII. Report published in 2002
(reference 5).
— 2003 Advice on static magnetic fields,
see response to question 2.
ICNIRP's advice on limiting exposure to non-ionising
radiations and fields is published in the public domain with the
aim of providing science-based Guidelines that health and safety
professionals and others might use as part of a system of health
protection. In addition, ICNIRP has always recognised that the
Guidelines might be used as a basis for national recommendations
or even regulations. However, ICNIRP looks to the authority developing
or promoting the system of health protection, which could include
egulations, to consider aspects related to its practical implementation.
This concept is set out in ICNIRP's leaflet "The development
of Guidance on Protection", where it is stated "ICNIRP
recognizes that the acceptability and adoption of a complete system
of protection also requires data and evaluations based on social
economic and political considerations. It is ICNIRP's view that
these matters are more appropriate to the functions of national
governments and their designated authorities. ICNIRP and other
advisory bodies may, however, provide background information of
relevance for such evaluations."
In relation to the current Directive, ICNIRP
did not provide specific advice to the Commission about "the
inclusion of (a) static fields and (b) time-varying fields"
or otherwise, apart from that referred to in response to question
2 below.
Response—uncertainties
ICNIRP published its recommendations (Guidelines)
on limiting exposure to static fields in 1994 (reference 6) and
to time-varying fields in 1998 (reference 7). The recommended
basic restrictions and reference levels contained in the Guidelines
were used by the Commission in formulating the Council recommendations
for limiting exposure of the public to electromagnetic fields
in 1999 (reference 8) and for the Directive (reference 9). The
uncertainties related to the interpretation of the scientific
data and ICNIRP's choice of `safety factors' have been discussed
at seminars and conferences and are addressed in ICNIRP's Statement
on "Use of the ICNIRP EMF Guidelines" of 32 March, 1999
(reference 10). Here it is noted:
"Thus, summarizing the evidence for health
effects for current densities greater than 10 mA m-2, ICNIRP decided
to limit human exposure to fields that induce current densities
not greater than 10 mA m-2 in the head, neck, and trunk at frequencies
of a few hertz up to 1 kHz. As a consequence, the safety factor
around 1 kHz may be unnecessarily conservative, but this is the
result of insufficient knowledge, and ICNIRP will reconsider this
as soon as more scientific data are available. With regard to
severe and potentially life-threatening effects such as cardiac
extrasystoles, ventricular fibrillation, muscular tetanus, and
respiratory failure, the safety factor between these effects and
the basic restriction is about 100 or greater. This is the same
order of magnitude as safety margins limiting exposure to dangerous
toxicologic substances".
Uncertainties and safety factors are also referred
to in the ICNIRP guideline publications
themselves. For example:
— Health Physics, Volume 66, pp
100-106 (1994)—Static Magnetic Field Guidelines
— Page 103—"Current
scientific knowledge does not suggest any detrimental effects
on major developmental, behavioural, and physiological parameters
in higher organisms for transient exposure to static magnetic
flux densities up to 2 T."
— Page 104—". . . it
is recommended that the occupational exposure limit is a time
weighted average value of 200 mT during the working day with a
ceiling value of 2 T. Because the extremities do not contain large
blood vessels or critical organs, a limit of 5 T can be allowed.
The restriction of 200 mT is a conservative one based on the present
lack of knowledge of long term effects of exposure. For the reasons
just given, the exposure limit for the general public incorporates
an additional safety factor of 5 resulting in a continuous exposure
limit of 40 mT."
— Health Physics, Volume 74, pp
494-522 (1998)—Time varying Field Guidelines
— Page 494—"In establishing
exposure limits, the Commission (ICNIRP) recognizes the need to
reconcile a number of differing expert opinions. The validity
of scientific reports has to be considered, and extrapolations
from animal experiments to effects on humans have to be made.
The restrictions in these Guidelines were based on scientific
data alone; currently available knowledge, however indicates that
these restrictions provide an adequate level of protection from
exposure to time-varying EMF."
— Page 495—"These guidelines
will be periodically revised, and updated as advances are made
in identifying the adverse health effects of time-varying electric,
magnetic and electromagnetic fields."
— Page 508—"General
statement on safety factors. There is insufficient information
on the biological and health effects of EMF exposure of human
populations and experimental animals to provide a rigorous basis
for establishing safety factors over the whole frequency range
and for all frequency modulations. In addition, some of the uncertainty
regarding the appropriate safety factor derives from a lack of
knowledge regarding the appropriate dosimetry."
QUESTION 2
For what reason the ICNIRP advice (a) on static
fields and (b) on staff was withdrawn in 2003?
Response
The Commission (EC) was advised by ICNIRP in
2003 of the inadvisability of including static magnetic field
limits in the Directive. This was because ICNIRP was clear that
review of the relevant science was to be carried out in the near
future (completed) and, following such review, it was ICNIRP's
intention to consider revision of its exposure guidelines for
static magnetic fields (underway). The advice was relayed to the
Commission at an informal meeting between ICNIRP and Commission
representatives in June 2003 and by letter in September 2003,
following a request from the Italian EC Permanent Representative.
QUESTION 3
What advice was given by ICNIRP to the Commission
on the work that it had done on MR, during discussions on the
Directive?
Response
None specifically on occupational exposure and
little in general on MRI can be recollected.
ICNIRP's exposure Guidelines deal with all parts
of the electromagnetic spectrum and not with any particular device
or exposure situation or any specific small part of the spectrum.
ICNIRP has however published advice on protection of the patient
and volunteers from MRI, but these specifically do not address
occupational exposure of staff. This is clearly set out in those
Guidelines (references 11 and 12).
QUESTION 4
What contribution HPA and ICNIRP are making
to the revision of WHO guidelines on timevarying fields? (Q 893)
Response
It is ICNIRP not WHO which provides exposure
guidelines. WHO's principal role in non-ionising radiation protection
is through co-ordination of world-wide research efforts and health
risk assessment. ICNIRP has recently completed scientific reviews
of static and time varying EMF (including epidemiology, biology
and dosimetry) (reference 13). Along with other expert bodies,
through its publications, ICNIRP has provided input to WHO health
risk assessments on both static magnetic (and electric) fields
(reference 14) and time-varying extremely low frequency magnetic
fields (reference 15). These health risk assessments involve many
other WHO-invited experts, providing further breadth to the overall
scientific review process, and are valuable to ICNIRP in developing
its exposure Guidelines. ICNIRP is currently undertaking a revision
of its Guidelines on limiting exposure to static magnetic fields
and time-varying electric, magnetic and electromagnetic fields
of frequencies less than 100 kHz.
The Radiation Protection Division of HPA has
reviewed the scientific basis for the 1998 ICNIRP exposure Guidelines
for limiting exposure to time-varying EMF (reference 16) and has
recommended their use in the UK (reference 17). HPA has hosted
an ICNIRP/WHO International Workshop on Weak Electric Field Effects.
The Proceedings of this Workshop (reference 18) should provide
significant scientific input into the ICNIRP Guidelines revision
process. As a WHO national collaborative institution, HPA will
continue to support the WHO through the activities of the International
EMF Project by the provision of scientific input and review.
QUESTION 5
When the 2003 consultation on the revised guidelines
was commenced; when the responses were first published; and what
steps were taken to inform contributors and those affected of
the results of this consultation? (Q 913).
Response
The Consultation Document was published on 1
May 2003 on the NRPB website requesting comments by the end of
July 2003. All comments received were subsequently considered
in formulating the final review document (reference 16) and NRPB's
advice to Government (reference 17). The review and advice documents
were published on 31 March 2004. All responders to the consultation
were sent a thank-you letter on 29 March 2004 enclosing a copy
of the NRPB's advice and alerting them as to the intended publication
of a response report about the consultation (reference 19). All
responders to the consultation were again thanked by letter on
30 July drawing their attention to the publication of the response
document on the NRPB website and enclosing a copy of that response
document.
June 2006
REFERENCE DOCUMENTS
1. Allen SG, Bernhardt JH, Driscoll CMH,
Grandolfo M, Mariutti GF, Matthes R, McKinlay AF, Stenimetz M,
Vecchia P and Whillock M. "Proposals for basic restrictions
for protection against occupational exposure to electromagnetic
non-ionizing radiations. Recommendations of an international working
group set up under the auspices of the Commission of the European
Communities". Physica Medica VII(2): 77-89; 1991.
2. EC. "Non-ionizing radiation: Sources,
exposure and health effects". McKinlay AF. ed. ISBN 92-827-9276-5
(Brussels: EC Directorate General V). 1996
3. McKinlay AF, Bach-Andersen J, Bernhardt
JH, Grandolfo M, Hossman K-A, van Leeuwen FE, Hansson Mild K,
Swerdlow AJ, Verschave L and Veyret B. "Possible health effects
related to the use of radiotelephones: European Commission Expert
Group Report". (Brussels: European Commission). http://europa.eu.int/ISPO/infosoc/telecompolicy/en/Studyhr.doc
4. SNIWL. "Possible health implications
of subjective symptoms and electromagnetic fields". A report
prepared by a European expert group for the EC DG V. Bergqvist
U and Vogel E eds. ISBN 91-705-438-8 (Stockholm: Swedish National
Institute for Working Life). 1997.
5. ICNIRP. "Possible health risks to
the general public from the use of security and similar devices".
(Munich: International Commission on Non-Ionizing Radiation Protection)
Bernhardt JH, McKinlay AF, Matthes R eds. ISBN 3-934994-01-6.
2002
6. ICNIRP. "Guidelines on limits of
exposure to static magnetic fields". Health Physics
66:100- 106; 1994.
7. ICNIRP. "Guidelines for limiting
exposure to time-varying electric, magnetic and electromagnetic
fields up to 300 GHz". Health Physics 74:494-522;
1998.
8. EUC. "On the limitation of exposure
of the general public to electromagnetic fields (0 Hz to 300 GHz").
EU Council recommendation.
http://ec.europa.eu/enterprise/electr—equipment/lv/rec519.pdf
(1999/519/EC). 1999.
9. EC. "Corrigenda: On the minimum
health and safety requirements regarding the exposure of workers
to the risks arising from physical agents (electromagnetic fields):
Directive 2004/40/EC of the European Parliament and of the Council"
Official Journal of the European Communities L184/1. 24
May 2004.
10. ICNIRP. "The use of the ICNIRP
EMF Guidelines". ICNIRP Statement.
http://www.icnirp.org/documents/Use.htm 1999.
11. IRPA/INIRC. "Protection of the
patient undergoing a magnetic resonance examination". Health
Physics 61:923-928; 1991.
12. ICNIRP. "Medical magnetic resonance
(MR) procedures: Protection of patients". Health Physics
87:197-216; 2004.
13. ICNIRP. "Exposure to static and
low frequency electromagnetic fields, biological effects and health
consequences (0-100 kHz)." Review of the scientific evidence
on dosimetry, biological effects, epidemiological observations
and health consequences concerning exposure to static and low
frequency electromagnetic fields (0-100 kHz). Bernhardt JH, Matthes
R, McKinlay AF, Vecchia P, Veyret B, eds. (Munich: International
Commission on Non-Ionizing Radiation Protection): 2003.
14. WHO. "Static Fields Environmental
Health Criteria Monograph No.232". Available as pdf download
at http://www.who.int/peh- emf/publications/reports/ehcstatic/en/index.html
15. WHO. "ELF Fields Environmental
Health Criteria Monograph No.???". Awaiting publication.
16. McKinlay AF, Allen SG, Cox R, Dimbylow
PJ, Mann SM, Muirhead CR, Saunders RD, Sienkiewicz ZJ, Stather
JW and Wainwright PR. "Review of the scientific evidence
for limiting exposure to electromagnetic fields (0-300 GHz)".
Documents of the NRPB: 15(3). 2004.
17. McKinlay AF, Allen SG, Cox R, Dimbylow
PJ, Mann SM, Muirhead CR, Saunders RD, Sienkiewicz ZJ, Stather
JW and Wainwright PR. "Advice on limiting exposure to electromagnetic
fields (0-300 GHz)". Documents of the NRPB: 15(2). 2004.
18. ICNIRP/WHO. "Proceedings international
workshop: Weak electric field effects in the body". McKinlay
AF and Repacholi MH eds. Radiation Protection Dosimetry
106(4). 2003.
19. McKinlay AF, Allen SG, Cox R, Dimbylow
PJ, Mann SM, Muirhead CR, Saunders RD, Sienkiewicz ZJ, Stather
JW and Wainwright PR. "Proposals for limiting exposure to
electromagnetic fields (0-300 GHz): Summary of comments received
on the May 2003 Consultation Document and responses from NRPB".
NRPB-W59. 2004.
| 
