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 standardsFear of “radiation”Differences in RF safety standards

between countries

Issues in experimental science

RF dosimetry is complicatedMany effects not repeatable but still

cause concern Inadequate attention to engineering

and biological details in experimentsPositive 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 ovensFCC, 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 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 commentGuidelines endorsed by US Government health/safety

agencies: FDA, EPA, NIOSH, OSHARule citations: Title 47, US Code of Federal

Regulations, Sections 1.1307(b), 1.1310, 2.1091, 2.1093

FCC regulatory policy

Exposure guidelines based on Specific Absorption Rate (SAR)

SAR = rate energy absorbed per unit massUnits: 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 effectsShocks, burns, and resulting tissue damageNon-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 AveragingRange Field Strength Field Strength Density Time (MHz) (V/m) (A/m) (mW/cm

2) (minutes)

__________________________________________________________________________

0.3-3.0 614 1.63 (100)* 63.0-30 1842/f 4.89/f (900/f

2)* 6

30-300 61.4 0.163 1.0 6300-1500 -- -- f/300 61500-100,000 -- -- 5 6___________________________________________________________________________

(B) Limits for General Population/Uncontrolled Exposure___________________________________________________________________________Frequency Electric Magnetic Power AveragingRange Field Strength Field Strength Density Time (MHz) (V/m) (A/m) (mW/cm

2) (minutes)

___________________________________________________________________________

0.3-1.34 614 1.63 (100)* 301.34-30 824/f 2.19/f (180/f

2)* 30

30-300 27.5 0.073 0.2 30300-1500 -- -- f/1500 301500-100,000 -- -- 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 otherEurope: many countries adopting ICNIRP limit of

2.0 W/kg averaged over 10 grams of tissue ICNIRP limit less conservative than IEEE limit

RF guidelines: 300 kHz-100 GHzTechnical 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

FCC regulations

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 activityAssessments and education

FDA cooperative research program

Cooperative Research and Development Agreement (CRADA) with the Cellular Telecommunications & Internet Association

FDA provides scientific and technical oversightThree 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 problemsDose response relations establishedThreshold 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 completedVast majority show no effect - no consistent positive

result suggests an adverse health effectNeed 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 ProtectionEuropean Commission Expert GroupRoyal Society of Canada Expert GroupU.K. National Radiological Protection BoardU.K. Independent Expert Group on Mobile

PhonesFrench Expert Report Spanish Expert ReviewCommon 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 safetySAR values for mobile phones availableLinks to other Web sitesAlso, 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 informationBuild trust in information sources

Independence & timeliness of information is important

Use appropriate analogies for riskExplain the scientific processListen to what the public is saying &

honestly address their concerns

RF biological research & dosimetry are complicatedEstablishing 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

What can we conclude?