1. Wireless Communications & Health in the USA: issues, regulatory policies & research International Scientific Workshop on Health Aspects of Mobile Telephony, Brussels 29-30 October 2001

2. Members of US delegation zRobert Cleveland, Ph.D. ySenior Scientist, Federal Communications Commission zC.K. Chou, Ph.D. yChief EME Scientist, Motorola Florida Research Laboratories zJerrold Bushberg, Ph.D. yClinical Professor, School of Medicine, Univ. of California, Davis zJoe Elder, Ph.D. yDirector, Biological Research, Motorola Florida Research Laboratories zJames Lin, Ph.D. yProfessor, Elec.Engineering & Bioengineering, Univ. of Illinois, Chicago zRussell Owen, Ph.D. yChief, Radiation Biology Branch, Food & Drug Admin. (CDRH)

3. Topics to be addressed Public concern Regulations and jurisdiction Policy development Research Consumer outreach & education Risk assessment

4. Health/safety issues have been raised for both phones and base stations

5. Some sources of controversy zMedia reports zConflicting scientific reports zLack of confidence in RF standards zFear of radiation zDifferences in RF safety standards between countries

6. Issues in experimental science zRF dosimetry is complicated zMany effects not repeatable but still cause concern zInadequate attention to engineering and biological details in experiments zPositive effects that are later proven to be artifacts

7. 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 z Final GAO report (May 2001) concluded: No evidence of adverse health effects to date y However cannot conclude no risk y No definitive answers likely for some time y FCC & FDA provide better information to consumers Measurement standard needed for phone SAR

8. US Federal Communications Commission & US Food and Drug Administration zFCC & FDA share regulatory jurisdiction for wireless communications safety zFCC adopted revised RF exposure guidelines in 1996 yapply to both fixed & mobile/portable transmitters zFDA jurisdiction emphasizes radiation emissions from consumer/industrial products (ionizing, RF, UV, etc) yCenter for Devices & Radiological Health (CDRH) zFDA RF standard: microwave ovens zFCC, FDA & other US health/regulatory agencies are members of an inter-agency RF working group

9. RF exposure standards zInternational Commission on Non-Ionizing Radiation Protection (ICNIRP) zInstitute of Electrical and Electronics Engineers (IEEE) zNational Council on Radiation Protection and Measurements (NCRP) zFCC (USA) guidelines based on NCRP & IEEE yAlso, US military uses IEEE standard

10. zFCC not a health/safety agency but must comply with National Environmental Policy Act zFCC relies on expert organizations & agencies for guidance on health/safety issues zGuidelines adopted after extensive public comment zGuidelines endorsed by US Government health/safety agencies: FDA, EPA, NIOSH, OSHA zRule citations: Title 47, US Code of Federal Regulations, Sections 1.1307(b), 1.1310, 2.1091, 2.1093 FCC regulatory policy

11. Exposure guidelines based on Specific Absorption Rate (SAR) zSAR = rate energy absorbed per unit mass zUnits: watts/kg (W/kg) or milliwatts/gm (mW/g) z IEEE, NCRP & ICNIRP all identify 4 W/kg as threshold for potentially harmful effects z Limits for localized exposure, field strength & power density all traceable to this value

12. Scientific basis for standards zScience-based standards (all effects considered) zThermal effects zShocks, burns, and resulting tissue damage zNon-thermal effects not found hazardous zThreshold for potential harm: y4 W/kg (whole-body) xBased on behavioral changes in animals yBasis for IEEE, ICNIRP, NCRP exposure limits

14. RF exposure standards for mobile telephones zUSA: FCC uses IEEE limit of 1.6 W/kg averaged over one gram of tissue zOther countries using 1.6 W/kg include Canada, Korea & Australia zSome countries (example China) considering other zEurope: many countries adopting ICNIRP limit of 2.0 W/kg averaged over 10 grams of tissue zICNIRP limit less conservative than IEEE limit

15. zRF guidelines: 300 kHz-100 GHz zTechnical documents providing techniques for evaluating exposure yOET Bulletin 65 + Supplements A, B & C zMobile phone approval requires SAR test data zFCC will conduct compliance testing of mobile phones zFCC and FDA staff working with IEEE committees developing guidelines for exposure & measurements yExample, IEEE SCC34: developing recommended practice for measuring SAR from mobile phones FCC regulations

17. FDA activities zRadiation Control for Health & Safety Act of 1968 yApplies to radiation-emitting electronic products zLong term animal studies yWork with National Toxicology Program & other groups yExposure assessment & test method development zCellular and animal experiments on enzyme activity zAssessments and education

18. FDA cooperative research program zCooperative Research and Development Agreement (CRADA) with the Cellular Telecommunications & Internet Association zFDA provides scientific and technical oversight zThree parts yMicronucleus assay yEpidemiology yOther topics

19. Resolving scientific questions about RF safety zNo single piece of research can definitely answer any scientific question zConclusions must be based on consensus drawn from cumulative evidence zReports of effects must be subjected to appropriate scientific scrutiny

20. Development of science-based policy Must be based on scientific data z Empirical evidence evaluated z Sources of uncertainty identified z Establish level of protection z Exposure assessment and evaluation of measurement capabilities necessary

21. What can be provided by the scientific process? zScientific approach prescriptive & predictive power zEstablish effects which cause identifiable health problems zDose response relations established zThreshold values established zWhere possible identify mechanism of action

22. Science-based research needed for making policy decisions Goal is replication and consistency z Need critical number of scientists working on a large number of projects z Government and independent support and commitment needed y Industrial sector can complement Government involvement important for general public acceptance

23. Science-based approach requires multiple projects Biological systems and organisms are complex z Responses may vary for similar exposures z Reproducibility & independently repeated studies required for evidence and statistical significance z Repeatability and confirmation fundamental to the scientific approach

24. Research to date on mobile telephony and health zApproximately 300 studies, almost 200 completed zVast majority show no effect - no consistent positive result suggests an adverse health effect zNeed to understand basic mechanism causing any biological response to determine relevance to wireless technologies zOnly RF effects in two main areas established: yThermal effects of RF energy yNeurostimulation by RF fields and currents

25. Studies conducted in the US zAbout 300 studies worldwide related to mobile telephony y80 studies ongoing or completed in US zAll studies contribute to the total picture and should not be considered in isolation zCurrent major studies include: yStudies at Washington University yBattelle-Pacific National Laboratory yFDA/CTIA CRADA yAnimal studies planned by US NTP (NIEHS) yUS Air Force research

26. Recent expert scientific reviews zWorld Health Organization zInternational Commission on Non-Ionizing Radiation Protection zEuropean Commission Expert Group zRoyal Society of Canada Expert Group zU.K. National Radiological Protection Board zU.K. Independent Expert Group on Mobile Phones zFrench Expert Report zSpanish Expert Review zCommon conclusion: No credible evidence that RF exposures within accepted limits cause adverse health effects

27. How is public opinion formed? zMedia reports yCorrections to erroneous reports usually not subsequently reported zStatements from experts zRumors and word of mouth Note: members of the general public rarely read scientific journals

28. Sources for consumer outreach & education zGovernment agencies (FCC, FDA) zIndustry (manufacturers, service providers) yMany now provide SAR & standards information zTrade associations (CTIA in USA) yCTIA-certified phones must provide SAR information zInternational organizations (WHO, ICNIRP) zScientific organizations (BEMS) zMiscellaneous Web sites

29. FCC Internet Site for RF Safety: www.fcc.gov/oet/rfsafety zFrequently asked questions (FAQs) zTexts of FCC decisions zFCC publications on RF safety zSAR values for mobile phones available zLinks to other Web sites zAlso, dedicated telephone line for information: +1-202-418-2464

30. FDA Web site: www.fda.gov/cdrh/phones

31. Joint FDA/FCC Web site on mobile phone safety Under Development

32. Public perception of risk zFact: In general people & the press focus on bad news more than good news zProposition: 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

33. Public perception of risk zConsequence: 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 zConclusion: 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

34. Risk communication & educating the general public zSimplify technical information zBuild trust in information sources yIndependence & timeliness of information is important zUse appropriate analogies for risk zExplain the scientific process zListen to what the public is saying & honestly address their concerns

35. zRF biological research & dosimetry are complicated zEstablishing health/safety standards based on research is even more complicated & requires judgement & assumptions in lieu of complete knowledge zIn future: we will know more about what we question today but...we may also have new questions zWhile this is the very nature of scientific research…it can be, in fact, very counterintuitive to the general public What can we conclude?