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EMFNEAR -
Exposure at UMTS
electromagnetic fields: study
on potential adverse effects on
hearing
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Description
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Action
Improving
information and knowledge for the
development of public health
Area of
activity
Environmental health
determinants
Summary
In the last decade the European
public concern was growing on the
potential adverse health effects due to
the use of mobile phones. Their use and
any consequent biological effect and/or
health risk cannot be reduced to an
issue of personal lifestyle but
involves the whole population, and
should be considered as a high-priority
environmental health issue. The
research on the effects of exposure to
the cellular phones non-ionizing
radiation is already well established
in Europe, but it is well known that
also very small changes in frequency
and modulation strongly influence the
effects of the exposure to
electromagnetic fields of any type.
Europe is now facing a new era in
mobile telecommunication, due to the
introduction of the Universal Mobile
Telecommunications System (UMTS), a key
member of the "global family" of the 3G
mobile technologies, the natural
evolution of the GSM networks. UMTS is
already a reality in Europe and greatly
differs from GSM in frequencies and
patterns used (about 2 versus 0,9-1,8
GHz and code-division multiple access
CDMA versus time-division multiple
access TDMA).
Research on the effects of UMTS
exposure is at its very early stage,
and no systematic research project is
addressing this emerging health
problem. Europe needs to be aware of
potential problems and risks arising
from this new emerging communication
technology at the earliest possible
time, to take appropriate steps to
address them. EMFnEAR is an exploratory
project with an anticipatory function
which addresses the study of the
potential health effects of UMTS phones
on the hearing system of animals and
humans, actually a highly sensitive
biological system to exogenous and
endogenous agents. The EMFnEAR results
will represent the first international
and European statement about this type
of hazards for hearing contributing to
the definition of the exposure limits
at this modulation and frequency band,
and, consequently, to the revision of
Council Recommendation
1999//519/EC.
More info...
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Financing
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Leader
organisation
CNR - Consiglio Nazionale
delle Ricerche
Istituto di Ingegneria Biomedica
Corso Stati Uniti 4
35127 Padova
ITALY
E mail: isibmi.cnr@polimi.it
Website : www.isib.cnr.it
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Contact Person
Paolo RAVAZZANI
CNR - Consiglio Nazionale delle Ricerche Istituto di Ingegneria Biomedica
Piazza Leonardo da Vinci 32
20133 Milano
ITALY
Tel: +39.02.2399.3344
Fax: +39 02.2399.3367
paolo.ravazzani@polimi.it
http://www.emfnear.polimi.it
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Associated
beneficiaries
-Ente per le Nuove
Tecnologie, l'Energia e l'Ambiente
(ENEA) - established in Italy (IT)
-Centre National de la
Recherche Scientifique - Délégation
Rhône-Alpes (CNRS) - established in
France (FR)
-University of Southampton
(ISVR) - established in United
Kingdom (UK)
-Kaunas University of
Medicine - Institute of Biomedical
Research (KMU) - established in
Lithuania (LT)
-"Jozsef Fodor" National
Centre of Public Health (NIRR) -
established in Hungary (HU)
-Nofer Institute of
Occupational Medicine (NIOM) -
established in Poland (PL)
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Starting date
and duration of project
- 15.12.2004
- 30 months
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Total
cost
1.239.146,00 €
Subsidy from
the Commission
709.659,00 €
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Outcomes
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Work package n° 1 - Central
Coordination and management
activities
Central Coordination and
management activities:
ensure the basic
infrastructures to EMFnEAR, for
co-ordination and administration,
to make project EMFnEAR to proceed
as planned, on time and within
budget.
Work package n° 2 - Design,
development and manufacturing of
localized exposure systems
Design, development and
manufacturing of localized exposure
systems. These systems, although
structurally and geometrically
different for humans and animals,
should be able for both
applications to reproduce the field
generated by UMTS mobile
telephony.The systems (one type for
animal exposure and the other one
for humans) should allow the
setting of the level of exposure in
terms of total power (i.e.,
allowing the control of the dose at
which the animals will be exposed
to). These systems will be designed
and developed also taking into
consideration the experience that
the involved teams acquired in the
course of project GUARD in the
design of similar systems at
different frequency and modulation
(GSM). As to the mechanical systems
for sizing, shaping and positioning
the exposure systems for both
animals and humans, the Project
Board already agreed in using the
same devices already designed and
manufactured.
Work package n° 3 - Design
protocols for animal exposure and
measuring the effects on the
hearing system
Design protocols for
animal exposure and measuring the
effects on the hearing system. The
PB already agreed that the
protocols for animal exposure and
audiological assessment will share
close similarities with those one
generated in the lifetime of
project GUARD. These protocols will
define the exposure procedure of
Sprague Dawley rats,
including the study of the
potential combined effect of UMTS
EMF exposure and other ototoxic
agents such as gentamicin.
Sham-exposure will be performed in
all the types of experiments.
Statistical analysis will be
performed on the data recorded pre-
and post-exposure and from the
sham-exposure animals.
Work package n° 4 - Design of
protocols for human exposure and
audiological assessment. Laboratory
studies (within-subject study)
Design of protocols for
human exposure and audiological
assessment. Laboratory studies
(within-subject study)
The Project Board already
agreed that the protocols for human
exposure and audiological
assessment will share close
similarities with those one
generated in the lifetime of
project GUARD
This protocol
(within-subject study) will be
based on the laboratory
experimental exposure of the
subjects. It share close
similarities with animal protocols.
All involved subjects
should undertake an audiological
battery of test pre- and
post-exposure.
Work package n° 5 - Design of protocols for human exposure and audiological assessment.
Additional test
The works focuses on the definition of additional test for the audiological
assessment of the human subjects, additional recording sessions and additional exposure system,
such as some within-subjects studies (CAS effect on DPOAE), delayed audiological assessment, exposure
of subjects up to the maximum SAR (Specific Absorption Ratio) level permitted by current regulation
(allowing to give additional answers on possible adverse effects when the worst case in exposure is
taken into consideration).
Work package n° 6 - Animal
exposure: effect of the SAR level
(dose) and of exposure times
Animal exposure: effect
of the SAR level (dose) and of
exposure times
Exposure of animals and
measuring of the effects on the
hearing system as a function of the
change in parameters such as
exposure time and SAR level. The
exposure will be performed by means
of the exposure and positioning
systems delivered in WP 2 and
according to the protocols
delivered in WP 3.
Work package n°7 - Animal
exposure: combined potentiating
effect of UMTS microwaves on the
ototoxicity of gentamicin (GM)
Animal exposure:
combined potentiating effect of
UMTS microwaves on the ototoxicity
of gentamicin (GM)
Investigation on the
combined effect of UMTS microwaves
on the ototoxicity of gentamicin
(GM) in the experimental animals
(Sprague-Dawley rats). This
activities will be based on the
protocols delivered in WP3.
Work package n° 8 - Human
exposure and audiological
assessment. Laboratory studies
(within-subject study)
Human exposure and
audiological assessment. Laboratory
studies (within-subject study)
Study of the potential
effects on hearing of exposure to
UMTS microwaves based on controlled
laboratory exposure of human
subjects
Work package n°9 - Human exposure and audiological assessment. Additional tests
These activities will be based on the protocols delivered in WP5. Also in this case, the activity of
this Workpackage during its lifetime will strictly influenced by the results obtained at the same time by the
linked WP 10 (Central Data Processing Unit)
Work package n° 10 - Analysis
and processing of the data
Analysis and processing
of the data
Centralized data processing
of all data obtained from the
experiments to quantify the effects
of exposure on the hearing system
with the activation of a
Centralized Data Processing Unit.
The procedures will differ
according to whether the data refer
to the animal experiments (repeated
measures for different exposure
levels) or to the two human studies
(within-subject study). Statistical
analysis of all processed data.
Work package n° 11 -
Dissemination and exploitation of
the results
Dissemination and
exploitation of the results
The dissemination activities
of EMFnEAR will be performed in
close link with the activities of
all other WPs. As general remark,
considering that EMFnEAR is an
exploratory project with an
anticipatory function on the
investigation on the health effect
of UMTS phones, it is expected that
during the project lifetime, and
particularly during year 2, its
results will be of great impact
from both scientific and
manufacturer point of view.
Moreover, it will be of great help
in the design and implementation of
the European strategic plans of
decision-making by public
authorities, contributing to the
definition of the exposure limits
at this modulation and frequency
band, and, consequently, to the
revision of Council Recommendation
1999/519/EC.
Work package n° 12 - Monitoring
of secondary aims
Monitoring of the secondary
aims
Monitoring of the influence
of age and pathological
conditions.
Interim
report, December 15, 2004 -
March 15, 2006
(173
KB)
Annexe
A
(190
MB)
Annexe
B
(336
KB)
Final
report, December 15, 2004 – June 14, 2007
(315
KB)
Annexe
A
(2.4
MB)
Annexe
B
(90
KB)
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More
info
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Statement of
project aim(s) and
objectives
General objectives:
EMFnEAR is an exploratory
project with an anticipatory
function which addresses the study
of the potential health effects of
UMTS phones on the hearing system
of animals and humans, which is a
highly sensitive biological system
to exogenous and endogenous agents
and the first one to be affected by
the microwaves. The EMFnEAR results
will represent the first
international and European
statement about this type of
hazards for hearing. EMFnEAR, based
on the experimental study of the
effects of UMTS on humans and
animals, will allow investigations
on inter-species variability and in
different species, in order to
limit uncertainties, to establish a
more reliable data set and to
improve the scientific basis for
extrapolation from animal data to
humans. The EMFnEAR results will
give a contribution to the revision
of Council Recommendation
1999/519/EC on the limitation of
exposure of the general public to
electromagnetic fields in the
frequency region around UMTS 2 GHz.
Specific objectives:
Study of the potential
effects on the hearing system of
animals and humans of UMTS
microwaves, by laboratory
experimentation, including also
study of the potential
hearing-related cognitive effects
and combined effects of UMTS fields
and ototoxic agents.
Support informed
decision-making by health and
environmental authorities and
public information.
Provide industry with
adequate information for assessing
and managing the potential risks of
UMTS standard for hearing, defining
general guidelines to producers, to
improve the control and reduction
of the potential health risk.
Contribution to the
definition of the exposure limits
at this modulation and frequency
band, and, consequently, to the
revision of Council Recommendation
1999/519/EC.
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Methods
The project will employ
methodology that is able to detect
very small effects on the hearing
system with appropriate statistical
power.
The project involves studies
of laboratory animals and humans.
The human studies will be performed
after the initial animal
experiments, the results of which
will inform the detailed design of
the human studies.
The animal studies will
involve both a longitudinal
assessment of acute effect of short
and long-term exposure and
cross-sectional comparison of
groups of exposed animals. The
human studies will involve both
longitudinal assessment of acute
effects only of short-term exposure.
Statistical analysis will be
performed on all the data.
The EMFnEAR network
experience from the EC FP5 project
GUARD will assure the capability to
tackle any problem or risk that
might hinder the work, such as
difficulties in the subjects
recruitment or delay due to the
ethical committee approvals.
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