Download Mr. R. Cleveland

Wireless Communications &
Health in the USA: issues,
regulatory policies & research
International Scientific Workshop on Health
Aspects of Mobile Telephony, Brussels
29-30 October 2001
Members of US delegation
 Robert Cleveland, Ph.D.
Senior Scientist, Federal Communications Commission
 C.K. Chou, Ph.D.
Chief EME Scientist, Motorola Florida Research Laboratories
 Jerrold Bushberg, Ph.D.
Clinical Professor, School of Medicine, Univ. of California, Davis
 Joe Elder, Ph.D.
Director, Biological Research, Motorola Florida Research Laboratories
 James Lin, Ph.D.
Professor, Elec.Engineering & Bioengineering, Univ. of Illinois, Chicago
 Russell Owen, Ph.D.
Chief, Radiation Biology Branch, Food & Drug Admin. (CDRH)
Topics to be addressed
Public concern
 Regulations and jurisdiction
 Policy development
 Research
Consumer outreach & education
Risk assessment
Health/safety issues have been raised
for both phones and base stations
Some sources of controversy
Media reports
Conflicting scientific reports
Lack of confidence in RF standards
Fear of “radiation”
Differences in RF safety standards
between countries
Issues in experimental science
RF dosimetry is complicated
Many effects not repeatable but still
cause concern
Inadequate attention to engineering
and biological details in experiments
Positive effects that are later proven to
be artifacts
Concern in USA over potential RF
health effects from mobile phones
 US General Accounting Office (GAO) asked
by US Congress to prepare report on mobile
phone safety
 Final GAO report (May 2001) concluded:
 No evidence of adverse health effects to date
 However cannot conclude no risk
 No definitive answers likely for some time
 FCC & FDA provide better information to
consumers
 Measurement standard needed for phone SAR
US Federal Communications Commission &
US Food and Drug Administration
FCC & FDA share regulatory jurisdiction for wireless
communications safety
FCC adopted revised RF exposure guidelines in 1996
apply to both fixed & mobile/portable transmitters
FDA jurisdiction emphasizes radiation emissions from
consumer/industrial products (ionizing, RF, UV, etc)
Center for Devices & Radiological Health (CDRH)
FDA RF standard: microwave ovens
FCC, FDA & other US health/regulatory agencies are
members of an inter-agency RF working group
RF exposure standards
International Commission on Non-Ionizing
Radiation Protection (ICNIRP)
Institute of Electrical and Electronics Engineers
(IEEE)
National Council on Radiation Protection and
Measurements (NCRP)
FCC (USA) guidelines based on NCRP & IEEE
Also, US military uses IEEE standard
FCC regulatory policy
FCC not a health/safety agency but must comply with
National Environmental Policy Act
FCC relies on expert organizations & agencies for
guidance on health/safety issues
Guidelines adopted after extensive public comment
Guidelines endorsed by US Government health/safety
agencies: FDA, EPA, NIOSH, OSHA
Rule citations: Title 47, US Code of Federal
Regulations, Sections 1.1307(b), 1.1310, 2.1091, 2.1093
Exposure guidelines based on
Specific Absorption Rate (SAR)
SAR = rate energy absorbed per unit mass
Units: watts/kg (W/kg) or milliwatts/gm
(mW/g)
 IEEE, NCRP & ICNIRP all identify 4 W/kg
as threshold for potentially harmful effects
 Limits for localized exposure, field strength
& power density all traceable to this value
Scientific basis for standards
Science-based standards (all effects considered)
Thermal effects
Shocks, burns, and resulting tissue damage
Non-thermal effects not found hazardous
Threshold for potential harm:
4 W/kg (whole-body)
Based on behavioral changes in animals
Basis for IEEE, ICNIRP, NCRP exposure limits
Table 1. FCC Limits for Maximum Permissible Exposure (MPE)
(A)
Limits for Occupational/Controlled Exposure
__________________________________________________________________________
Frequency
Electric
Magnetic
Power
Averaging
Range
Field Strength
Field Strength
Density
Time
2
(MHz)
(V/m)
(A/m)
(mW/cm )
(minutes)
__________________________________________________________________________
0.3-3.0
614
1.63
(100)*
6
2
3.0-30
1842/f
4.89/f
(900/f )*
6
30-300
61.4
0.163
1.0
6
300-1500
--f/300
6
1500-100,000
--5
6
___________________________________________________________________________
(B) Limits for General Population/Uncontrolled Exposure
___________________________________________________________________________
Frequency
Electric
Magnetic
Power
Averaging
Range
Field Strength
Field Strength
Density
Time
2
(MHz)
(V/m)
(A/m)
(mW/cm )
(minutes)
___________________________________________________________________________
0.3-1.34
614
1.63
(100)*
30
2
1.34-30
824/f
2.19/f
(180/f )*
30
30-300
27.5
0.073
0.2
30
300-1500
--f/1500
30
1500-100,000
--1.0
30
___________________________________________________________________________
f = frequency in MHz * = Plane-wave equivalent power density
RF exposure standards for mobile
telephones
USA: FCC uses IEEE limit of 1.6 W/kg averaged
over one gram of tissue
Other countries using 1.6 W/kg include Canada,
Korea & Australia
Some countries (example China) considering other
Europe: many countries adopting ICNIRP limit of
2.0 W/kg averaged over 10 grams of tissue
ICNIRP limit less conservative than IEEE limit
FCC regulations
RF guidelines: 300 kHz-100 GHz
Technical documents providing techniques for
evaluating exposure
OET Bulletin 65 + Supplements A, B & C
Mobile phone approval requires SAR test data
FCC will conduct compliance testing of mobile phones
FCC and FDA staff working with IEEE committees
developing guidelines for exposure & measurements
Example, IEEE SCC34: developing recommended practice
for measuring SAR from mobile phones
FDA activities
Radiation Control for Health & Safety Act of 1968
Applies to radiation-emitting electronic products
Long term animal studies
Work with National Toxicology Program & other groups
Exposure assessment & test method development
Cellular and animal experiments on enzyme activity
Assessments and education
FDA cooperative research
program
Cooperative Research and Development
Agreement (CRADA) with the Cellular
Telecommunications & Internet Association
FDA provides scientific and technical oversight
Three parts
Micronucleus assay
Epidemiology
Other topics
Resolving scientific questions
about RF safety
No single piece of research can definitely
answer any scientific question
Conclusions must be based on consensus
drawn from cumulative evidence
Reports of effects must be subjected to
appropriate scientific scrutiny
Development of science-based
policy
 Must be based on scientific data
 Empirical evidence evaluated
 Sources of uncertainty identified
 Establish level of protection
 Exposure assessment and evaluation of
measurement capabilities necessary
What can be provided by the
scientific process?
Scientific approach  prescriptive &
predictive power
Establish effects which cause identifiable
health problems
Dose response relations established
Threshold values established
Where possible identify mechanism of action
Science-based research needed
for making policy decisions
 Goal is replication and consistency
 Need critical number of scientists working on
a large number of projects
 Government and independent support
and commitment needed
 Industrial sector can complement
 Government involvement important for
general public acceptance
Science-based approach
requires multiple projects
 Biological systems and organisms are complex
 Responses may vary for “similar” exposures
 Reproducibility & independently repeated studies
required for evidence and statistical significance
 Repeatability and confirmation fundamental to the
scientific approach
Research to date on mobile
telephony and health
Approximately 300 studies, almost 200 completed
Vast majority show no effect - no consistent positive
result suggests an adverse health effect
Need to understand basic mechanism causing any
biological response to determine relevance to wireless
technologies
Only RF effects in two main areas established:
Thermal effects of RF energy
Neurostimulation by RF fields and currents
Studies conducted in the US
About 300 studies worldwide related to mobile
telephony
80 studies ongoing or completed in US
All studies contribute to the total picture and should
not be considered in isolation
Current major studies include:
Studies at Washington University
Battelle-Pacific National Laboratory
FDA/CTIA CRADA
Animal studies planned by US NTP (NIEHS)
US Air Force research
Recent 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
Spanish Expert Review
Common conclusion: No credible evidence that RF
exposures within accepted limits cause adverse
health effects
How is public opinion formed?
Media reports
Corrections to erroneous reports usually not
subsequently reported
Statements from “experts”
Rumors and “word of mouth”
Note: members of the general public rarely
read scientific journals
Sources for consumer outreach
& education
Government agencies (FCC, FDA)
Industry (manufacturers, service providers)
Many now provide SAR & standards information
Trade associations (CTIA in USA)
CTIA-certified phones must provide SAR
information
International organizations (WHO, ICNIRP)
Scientific organizations (BEMS)
Miscellaneous Web sites
FCC Internet Site for RF Safety:
www.fcc.gov/oet/rfsafety
Frequently asked questions (“FAQs”)
Texts of FCC decisions
FCC publications on RF safety
SAR values for mobile phones available
Links to other Web sites
Also, dedicated telephone line for
information: +1-202-418-2464
FDA Web site:
www.fda.gov/cdrh/phones
Joint FDA/FCC Web site on
mobile phone safety
Under Development
Public perception of risk
Fact: In general people & the press focus on
bad news more than good news
Proposition: A single study showing an
association between RF & an adverse health
effect will not be easily offset by numerous
studies failing to show an association
Public perception of risk
Consequence: As more research is performed it is
more likely that there will be increased public
concern, even if the majority of the studies fail to
show any adverse health effects
Conclusion: In the Short Term, risk assessment
studies tend to increase perceived risk - this does not
mean don't do them, but rather be prepared for the
result
Risk communication &
educating the general public
Simplify technical information
Build trust in information sources
Independence & timeliness of information is
important
Use appropriate analogies for risk
Explain the scientific process
Listen to what the public is saying &
honestly address their concerns
What can we conclude?
RF biological research & dosimetry are complicated
Establishing health/safety standards based on
research is even more complicated & requires
judgement & assumptions in lieu of complete
knowledge
In future: we will know more about what we question
today but...we may also have new questions
While this is the very nature of scientific research…it
can be, in fact, very counterintuitive to the general
public