Russell D. Owen Wireless Phones Russell D. Owen, Ph.D. Chief, Radiation Biology Branch, Division of Life Sciences CDRH Office of Science and Technology.

Russell D. Owen

Wireless Phones

Russell D. Owen, Ph.D.Russell D. Owen, Ph.D.Chief, Radiation Biology Branch, Division of Life Chief, Radiation Biology Branch, Division of Life

SciencesSciences

CDRH Office of Science and TechnologyCDRH Office of Science and Technology

Russell D. Owen, Ph.D.

Today’s Topics

Background on the IssueBackground on the Issue Biological Effects of RFBiological Effects of RF Activities to Address the IssueActivities to Address the Issue

Russell D. Owen, Ph.D.

Background

ExposureExposure EvidenceEvidence EffortsEfforts

Russell D. Owen, Ph.D.

RF Biological Effects

Notable FindingsNotable Findings Research PrioritiesResearch Priorities AssessmentAssessment

EpidemiologyEpidemiology Animal StudiesAnimal Studies Cellular StudiesCellular Studies

Russell D. Owen, Ph.D.

Studies of Human Populations(Epidemiology)

Few StudiesFew Studies Need to Study Highly Exposed PopulationsNeed to Study Highly Exposed Populations Difficulties in Exposure AssessmentDifficulties in Exposure Assessment

Russell D. Owen, Ph.D.

EpidemiologyMorgan et al.

Cohort Cohort OccupationalOccupational No Associations with RF ExposureNo Associations with RF Exposure No Wireless Phone DataNo Wireless Phone Data

Russell D. Owen, Ph.D.

EpidemiologyHardell et al. Cases vs. ControlsCases vs. Controls No Increase in Brain CancerNo Increase in Brain Cancer LateralityLaterality

not statistically significantnot statistically significant data re-analysisdata re-analysis localization complex dosimetry & pathologylocalization complex dosimetry & pathology recall bias ? (contralateral protection)recall bias ? (contralateral protection)

Russell D. Owen, Ph.D.

EpidemiologyMuscat et al. Primary Brain CancersPrimary Brain Cancers Cases vs. ControlsCases vs. Controls No AssociationNo Association No LateralityNo Laterality Sub-Type AnalysisSub-Type Analysis

Russell D. Owen, Ph.D.

EpidemiologyInskip et al. Glioma, Meningioma, & Acoustic NeuromaGlioma, Meningioma, & Acoustic Neuroma Cases vs. ControlsCases vs. Controls No AssociationNo Association No LateralityNo Laterality

Russell D. Owen, Ph.D.

EpidemiologyJohansen et al. CohortCohort

nationwidenationwide linked to cancer registrylinked to cancer registry

FindingsFindings no increase of brain or nervous system cancersno increase of brain or nervous system cancers no increase in leukemia no increase in leukemia significantly less cancers overallsignificantly less cancers overall

Russell D. Owen, Ph.D.

Epidemiology

Advantage: Extrapolation Not RequiredAdvantage: Extrapolation Not Required IssuesIssues

Magnitude of EffectsMagnitude of Effects InconsistenciesInconsistencies PlausibilityPlausibility

Russell D. Owen, Ph.D.

Animal Studies: Background

Szmgielski Szmgielski et al.et al. Tumor Invasion and Initiated TumorsTumor Invasion and Initiated Tumors

Chou Chou et al.et al. Chronic Bioassay in Rats (2450 MHz)Chronic Bioassay in Rats (2450 MHz)

Toler and Frei and Co-WorkersToler and Frei and Co-Workers Initiated Mammary Tumors in MiceInitiated Mammary Tumors in Mice 435 MHz and 2450 MHz435 MHz and 2450 MHz

Russell D. Owen, Ph.D.

Animal StudiesLong-Term Recent Negative StudiesRecent Negative Studies Current StudiesCurrent Studies

exposure at multiple dose ratesexposure at multiple dose rates elevated dose rate to maximize sensitivityelevated dose rate to maximize sensitivity

U.S. National Toxicology ProgramU.S. National Toxicology Program

Russell D. Owen, Ph.D.

Animal StudiesArtificially Initiated Tumors Pim-1 Mouse LymphomasPim-1 Mouse Lymphomas ENU Rat Brain TumorsENU Rat Brain Tumors B(a)P Rat SarcomaB(a)P Rat Sarcoma DEN Rat HepatomasDEN Rat Hepatomas Radiation Mouse LymphomasRadiation Mouse Lymphomas DMBA Rat Mammary TumorsDMBA Rat Mammary Tumors

Russell D. Owen, Ph.D.

Animal StudiesShort Term Negative DataNegative Data Calcium Alterations in Rat BrainCalcium Alterations in Rat Brain Body Weight ChangesBody Weight Changes Ornithine Decarboylase Activity in RatsOrnithine Decarboylase Activity in Rats Indirect DNA Damage in Rat BrainIndirect DNA Damage in Rat Brain

Russell D. Owen, Ph.D.

Cellular Studies

Negative DataNegative Data TransformationTransformation DNA DamageDNA Damage Gene ExpressionGene Expression Ornithine Decarboylase ActivityOrnithine Decarboylase Activity Cell GrowthCell Growth

Russell D. Owen, Ph.D.

Decisions Based on Science

ResearchResearch Scientific Literature ReviewScientific Literature Review Developing Research RecommendationsDeveloping Research Recommendations Testing and Test Method DevelopmentTesting and Test Method Development Guidelines and StandardsGuidelines and Standards

Collaboration is EssentialCollaboration is Essential

Russell D. Owen, Ph.D.

FDA Collaborators in RF

Russell D. Owen, Ph.D.

FDA Activities

Long Term Animal StudiesLong Term Animal Studies Exposure Assessment Exposure Assessment Test Method DevelopmentTest Method Development Cellular and Animal Experiments on Cellular and Animal Experiments on

Enzyme ActivityEnzyme Activity Assessments and EducationAssessments and Education Cooperative Research ProgramCooperative Research Program

Russell D. Owen, Ph.D.

Russell D. Owen, Ph.D.

Cooperative Research ProgramSupplements FDA Science Activities Cooperative Research and Development Cooperative Research and Development

Agreement with the Agreement with the Cellular Telephone and Cellular Telephone and Internet AssociationInternet Association

FDA Provides Scientific and Technical OversightFDA Provides Scientific and Technical Oversight Three PartsThree Parts

Micronucleus AssayMicronucleus Assay EpidemiologyEpidemiology Other TopicsOther Topics

Russell D. Owen, Ph.D.

Into the Future

Research to Fill Data GapsResearch to Fill Data Gaps Continual AssessmentContinual Assessment Safety Measures Based on ScienceSafety Measures Based on Science