Review of the Science

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Review of the Science

• Dr. Mays Swicord
• Director, EME Programs
• Motorola

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Outline

• WHO International EMF Project
• The state of the science
• The scientific process
• Dosimetry
• Standards

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WHO International EMF Project International
Collaboration

• International partners
• WHO, UNEP, ICNIRP, ILO, IEC
• IARC, NATO, ITU EC
• National partners gt45
• WHO collaborating institutions
• USA, UK, Japan, Sweden Germany
• Independent scientific institutions

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• International EMF Project
• Provides forum for co-ordinated international
  response to EMF issues
• Assesses scientific literature makes status
  report on health risks
• Identifies research needed to support more
  definitive health risk assessments
• Encourages focused research program with funding
  agencies
• Evaluates research results and publishes as WHO
  monographs
• Develops framework for international standards

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Research Backdrop

• Historical What has been studied and why
• What kind of research is employed?
• Epidemiolgical studies
• Human studies
• Animal studies
• Cell and tissue studies
• Dosimetry

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Research Objectives

• To continue to strengthen the extensive
  scientific database and address any questions
  raised by previous studies.
• Outcome more quality research and a more robust
  database lead to more definitive public policy
  decisions and enhance public confidence

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EME Research

• Research on possible RF health effects dates back
  more than 50 years and continues to serve as the
  basis for exposure standards and public health
  judgments around the world.

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Extensive scientific database

• WHO research database has more than 500 relevant
  completed or ongoing studies including 289 using
  mobile telephony signals
• http//www-nt.who.int/peh-emf/database.htm
• IEEE data base contains over 1400 publication
  http//grouper.ieee.org/groups/scc28/
• over 1100 of these publications report biological
  studies (population (epidemiological), human,
  animal, and cellular studies).
• The remaining reports are reviews and engineering
  studies.

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Mobile Telephony Related Studies

• Completed Ongoing Total
• Cancer Studies
• Epidemiologic studies 7 2 (IARC ) 9
  (IARC)
• Standard bioassays 6 8 14
• Sensitized in vivo studies 12 9
  21
• Relevant acute in vivo studies 13 2 15
• Related acute in vivo studies 14 10 24
• In vitro studies 44 24 68
• Total Cancer Studies 96 55 (IARC) 151
  (IARC)
• Non-Cancer Studies
• Acute in vivo studies 26 14 40
• In vitro studies 16 13 29
• Human Studies 45 24 69
• Total Non-Cancer Studies 87 51 138
• Grand Totals 183 106 (IARC) 289 (IARC)
• All studies are listed on the WHO web site
  http//www-nt.who.int/peh-emf/database.htm

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Non-Cancer Studies

• Completed Ongoing
• Human Studies
• Sleep and EEG 21 10
• Headache and Fatigue 3 0
• Hypersensitivity, 3 1
• Blood Pressure, Heart Rate 1 4
• Cognitive function and memory 4 2
• Hormonal changes 5 1
• Hearing auditory pathology 0 3
• Nerve conduction and muscle contraction 2
  0
• Eye pathology 1 1
• Other human studies 3 2
• Animal Studies
• Hearing and Auditory Pathology 3 1
• Hormonal changes and Immune function 8
  2
• Behavior 4 1
• Blood Brain Barrier 4 2
• Other Animal studies 7 8

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Recent Important Cancer Studies

• Three recently published epidemiology studies
• Cellular Telephones and Cancer A Nationwide
  Cohort Study in Denmark. Johansen et al. Journal
  of the National Cancer Institute. (2001)
  93203-206
• Cellular-Telephone Use and Brain Tumors. Inskip,
  et al. N Engl J Med (2001) 34479-86
• Handheld Cellular Telephone Use and Risk of Brain
  Cancer. Muscat et al. JAMA (2000)
  284(23)3001-3007
• These findings support the results of a large
  occupational study
• Radiofrequency Exposure and Mortality from Cancer
  of the Brain and Lymphatic/Hematopoietic Systems.
  Morgan et al. Epidemiology (2000) 11118-127

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Conclusions for Cancer Studies

• Current cancer related studies are extensive
  (more than 120) and fully address the WHO agenda.
• The majority of studies show no effect.
• Reports of effects are being addressed through
  replication.
• Those replication studies that have been
  completed have failed to confirm the original
  findings.
• There is a need to await the outcome of current
  studies to determine the need for more studies.

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Conclusions for Non-Cancer Studies

• A large number of non-cancer related studies have
  been conducted and have not produced effects.
• Several hypothesis generating studies require
  further research.
• Sleep disturbance and reaction time are examples
  of reported effects which require follow up.
• Studies are also planned or underway to address
  headaches, blood pressure and other possible
  responses.

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The Scientific Process

• How science works
• When is a reported effect a real effect?
• What is the role and importance of
  replication?

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RF Bioeffects Real? Relevant?Reports or
suggestions of possible effects must be subjected
to scientific scrutiny involving

• Confounders?
• Methodology?
• Consistent/repeatable?
• Relevant exposure?
• Bioeffect ? health effect?
• Animal ? human applicability?

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The Scientific Process begins with the report of
a novel finding

• Publication of a novel finding does not validate
  a study.
• Even though studies have been peer reviewed the
  scientific reviewers may not be able to detect
• Procedural errors,
• Poor techniques used by the laboratory
  technician,
• Unaccounted statistical variation in the
  experimental results.
• One out of every 20 experiments may show a
  statistically significant but false difference at
  a 95 confidence level.

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The Scientific Process continues with the
establishment of a finding

• Novel findings generate hypothesis.
• Other researchers must test such hypothesis by
• Replication of the original finding.
• Initiating complimentary experiments.
• A report of finding from a replication or
  complimentary study is necessary but not
  sufficient for validation.

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What is to be provided by the scientific process?

• Established effects which cause identified
• health problems
• Dose response
• Threshold values
• Where possible the mechanism of action
• Biological
• Physical

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What established effects have been identified as
a human hazard?

• 0 to 100 kHz
• Electric shocks and burns
• 100 kHz to 300 GHz
• Thermal
• Shocks, burns, and tissue damage

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Key points

• No single piece of research can definitely answer
  any scientific questions.
• Conclusions must be based on consensus drawn from
  cumulative evidence.
• Reports of effects must be subjected to
  appropriate scientific scrutiny
• Review of the research finds no demonstrated risk
  at these power levels or frequencies.

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What Has Research Shown?

• National and international independent expert
  panels have been consistent in concluding that
  scientific research has demonstrated no public
  health risks from the use of wireless phones or
  other radio products operating within accepted
  exposure guidelines.

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Expert Scientific Reviews

• World Health Organization
• International Commission on Non-Ionizing
  Radiation Protection
• European Commission Expert Group
• Royal Society of Canada Expert Group
• U.K. National Radiological Protection Board
• U.K. Independent Expert Group on Mobile Phones
• French Expert Report - Les téléphones mobiles,
  leurs stations de base et la santé (rapport du 18
  Janvier 2001)
• Common conclusion No credible evidence that RF
  exposures within accepted limits cause any
  adverse health effects

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Statements on RF Safety

• Americas
• Royal Society of Canada Expert Panel
• U.S. Food and Drug Administration
• Asia-Pacific Region
• Australian Committee on Electromagnetic Energy
  Public Health Issues
• Japanese Ministry of Post and Telecommunications
• Korean Ministry of Communications
• New Zealand Ministry of Health and Ministry of
  Environment
• Singapore Telecommunications Authority
• Europe, Middle East and Africa
• Austria Ministry for Health and Consumer
  Protection
• European Commission
• German Federal Office for Radiation Protection
• France Commission for Consumer Safety
• Netherlands Ministry of Health and Well-Being
• United Kingdom National Radiological Protection
  Board

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U.S. Food and Drug AdministrationOctober 1999

• The available scientific evidence does not
  demonstrate any adverse health effects associated
  with the use of mobile phones.

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There is no substantive evidence that adverse
health effects, including cancer, can occur in
people exposed to levels at or below the
limits. International Commission
onNon-Ionizing Radiation Protection April 1996
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A scientific review by WHO ... concluded that,
from the current scientific literature, there is
no convincing evidence that exposure to RF
shortens the life span of humans, induces or
promotes cancer. World Health Organization
October 1997
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U.K. Independent Expert Group(Stewart
Commission)May 2000

• The balance of evidence to date suggests that
  exposures to RF radiation below the NRPB and
  ICNIRP Guidelines do not cause adverse health
  effects to the general population.

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Dosimetry and Compliance Testing
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Dosimetry

• What is it?
• For EME it is the measurement of the distribution
  of SAR.
• Why is it important?
• Critical to quality research
• Critical for compliance testing

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RF Safety Standard Setting
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Science and RF Safety Guidelines

• In general, standard-setting organizations around
  the world base their recommendations on a common
  scientific understanding about the possible
  health effects of human exposure to radio waves.

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RF Safety Guidelines

• Substantial Margins to Assure Safety
• Set far below exposure levels where adverse
  effects are known to occur
• Two-Tier Exposure Limits
• Occupational and general public
• Manufacturers design, build and test their radio
  products to meet rigorous, science-based
  standards and guidelines related to RF safety.

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Current RF Exposure Limits

• General Public Occupational
• Whole Partial Whole Partial
• CENELEC Prestandard (1995) 0.08 2.0 0.4 10
• German DKE VDE 0848 (1991) 0.08 2.0 0.4 10
• U.S. FCC (1996) 0.08 1.6 0.4 8
• ICNIRP (1998) 0.08 2.0 0.4 10
• U.K. (2000) 0.08 2.0 0.4 10
• Australia/NZ AS2772.1 0.08 1.6 0.4 8
• All SARs expressed in watts per kilogram (W/kg)

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• EMF Standards Harmonisation
• Benefits
• Increased public confidence that governments and
  scientists agree on health risks
• Reduced debate and fears about EMF --
  precautionary principle?
• Everyone protected to the same high level

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International EMF ProjectStandards Harmonisation

• EMF Project will identify health risks using
  WHO/IARC procedures WHO does not develop
  standards
• ICNIRP full partner in EMF Project and publishes
  international guidelines using WHO health risk
  assessments
• WHOs EMF Project provides an international forum
  for consensus on standards development
• All major standards setting countries involved in
  Project

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• Precaution
• Growing movement to adopt precautionary
  approaches to manage health risks with scientific
  uncertainty
• WHO does not normally advise national authorities
  to set policies that go beyond established
  knowledge
• At Ministerial Conference on Environment and
  Health in London 1999, WHO encouraged to take
  into account the need to rigorously apply the
  Precautionary Principle in assessing risks and to
  adopt a more preventive, pro-active approach to
  hazards.

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Precautionary Principle European Commission
(2000)

• the precautionary principle is neither a
  politicisation of science nor the acceptance of
  zero-risk but that it provides a basis for action
  when science is unable to give a clear answer
  the precautionary principle is not a
  justification for ignoring scientific evidence
  and taking protectionist decisions.

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Can the Precautionary Principle be applied to EMF?

• No evidence for hazard at low-levels has been
  established
• Some gaps in knowledge exist focused research
• Large public concern
• Hence
• Under guidelines of EC Commentary (2000)
  Precautionary Principle SHOULD NOT be applied to
  EMF
• Precautionary measures can only be invoked to
  address public concerns not because of specific
  scientific data

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Summary of Safety Level Setting Process

• Hazard identification
• Risk analysis
• Determination of threshold if any
• Determination of uncertainties
• Establishment of level which provides adequate
  protection

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Thank You