Wireless Phones

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Wireless Phones

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

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Todays Topics

• Background on the Issue
• Biological Effects of RF
• Activities to Address the Issue

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Background

• Exposure
• Evidence
• Efforts

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RF Biological Effects

• Notable Findings
• Research Priorities
• Assessment
• Epidemiology
• Animal Studies
• Cellular Studies

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Studies of Human Populations(Epidemiology)

• Few Studies
• Need to Study Highly Exposed Populations
• Difficulties in Exposure Assessment

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EpidemiologyMorgan et al.

• Cohort
• Occupational
• No Associations with RF Exposure
• No Wireless Phone Data

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EpidemiologyHardell et al.

• Cases vs. Controls
• No Increase in Brain Cancer
• Laterality
• not statistically significant
• data re-analysis
• localization complex dosimetry pathology
• recall bias ? (contralateral protection)

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EpidemiologyMuscat et al.

• Primary Brain Cancers
• Cases vs. Controls
• No Association
• No Laterality
• Sub-Type Analysis

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EpidemiologyInskip et al.

• Glioma, Meningioma, Acoustic Neuroma
• Cases vs. Controls
• No Association
• No Laterality

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EpidemiologyJohansen et al.

• Cohort
• nationwide
• linked to cancer registry
• Findings
• no increase of brain or nervous system cancers
• no increase in leukemia
• significantly less cancers overall

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Epidemiology

• Advantage Extrapolation Not Required
• Issues
• Magnitude of Effects
• Inconsistencies
• Plausibility

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Animal Studies Background

• Szmgielski et al.
• Tumor Invasion and Initiated Tumors
• Chou et al.
• Chronic Bioassay in Rats (2450 MHz)
• Toler and Frei and Co-Workers
• Initiated Mammary Tumors in Mice
• 435 MHz and 2450 MHz

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Animal StudiesLong-Term

• Recent Negative Studies
• Current Studies
• exposure at multiple dose rates
• elevated dose rate to maximize sensitivity
• U.S. National Toxicology Program

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Animal StudiesArtificially Initiated Tumors

• Pim-1 Mouse Lymphomas
• ENU Rat Brain Tumors
• B(a)P Rat Sarcoma
• DEN Rat Hepatomas
• Radiation Mouse Lymphomas
• DMBA Rat Mammary Tumors

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Animal StudiesShort Term

• Negative Data
• Calcium Alterations in Rat Brain
• Body Weight Changes
• Ornithine Decarboylase Activity in Rats
• Indirect DNA Damage in Rat Brain

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Cellular Studies

• Negative Data
• Transformation
• DNA Damage
• Gene Expression
• Ornithine Decarboylase Activity
• Cell Growth

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Decisions Based on Science

• Research
• Scientific Literature Review
• Developing Research Recommendations
• Testing and Test Method Development
• Guidelines and Standards
• Collaboration is Essential

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FDA Collaborators in RF
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FDA Activities

• Long Term Animal Studies
• Exposure Assessment
• Test Method Development
• Cellular and Animal Experiments on Enzyme
  Activity
• Assessments and Education
• Cooperative Research Program

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Cooperative Research ProgramSupplements FDA
Science Activities

• Cooperative Research and Development Agreement
  with the Cellular Telephone and Internet
  Association
• FDA Provides Scientific and Technical Oversight
• Three Parts
• Micronucleus Assay
• Epidemiology
• Other Topics

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Into the Future

• Research to Fill Data Gaps
• Continual Assessment
• Safety Measures Based on Science