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, Ph.D. Today’s Topics n Background on the Issue n Biological Effects of RF n Activities to Address the Issue

Russell D. Owen, Ph.D. Background n Exposure n Evidence n Efforts

Russell D. Owen, Ph.D. RF Biological Effects n Notable Findings n Research Priorities n Assessment u Epidemiology u Animal Studies u Cellular Studies

Russell D. Owen, Ph.D. Studies of Human Populations (Epidemiology) n Few Studies n Need to Study Highly Exposed Populations n Difficulties in Exposure Assessment

Russell D. Owen, Ph.D. Epidemiology Morgan et al. n Cohort n Occupational n No Associations with RF Exposure n No Wireless Phone Data

Russell D. Owen, Ph.D. Epidemiology Hardell et al. n Cases vs. Controls n No Increase in Brain Cancer n Laterality u not statistically significant u data re-analysis u localization complex dosimetry & pathology u recall bias ? (contralateral protection)

Russell D. Owen, Ph.D. Epidemiology Muscat et al. n Primary Brain Cancers n Cases vs. Controls n No Association n No Laterality n Sub-Type Analysis

Russell D. Owen, Ph.D. Epidemiology Inskip et al. n Glioma, Meningioma, & Acoustic Neuroma n Cases vs. Controls n No Association n No Laterality

Russell D. Owen, Ph.D. Epidemiology Johansen et al. n Cohort u nationwide u linked to cancer registry n Findings u no increase of brain or nervous system cancers u no increase in leukemia u significantly less cancers overall

Russell D. Owen, Ph.D. Epidemiology n Advantage: Extrapolation Not Required n Issues u Magnitude of Effects u Inconsistencies u Plausibility

Russell D. Owen, Ph.D. Animal Studies: Background n Szmgielski et al. u Tumor Invasion and Initiated Tumors n Chou et al. u Chronic Bioassay in Rats (2450 MHz) n Toler and Frei and Co-Workers u Initiated Mammary Tumors in Mice u 435 MHz and 2450 MHz

Russell D. Owen, Ph.D. Animal Studies Long-Term n Recent Negative Studies n Current Studies u exposure at multiple dose rates u elevated dose rate to maximize sensitivity n U.S. National Toxicology Program

Russell D. Owen, Ph.D. Animal Studies Artificially Initiated Tumors n Pim-1 Mouse Lymphomas n ENU Rat Brain Tumors n B(a)P Rat Sarcoma n DEN Rat Hepatomas n Radiation Mouse Lymphomas n DMBA Rat Mammary Tumors

Russell D. Owen, Ph.D. Animal Studies Short Term n Negative Data n Calcium Alterations in Rat Brain n Body Weight Changes n Ornithine Decarboylase Activity in Rats n Indirect DNA Damage in Rat Brain

Russell D. Owen, Ph.D. Cellular Studies n Negative Data n Transformation n DNA Damage n Gene Expression n Ornithine Decarboylase Activity n Cell Growth

Russell D. Owen, Ph.D. Decisions Based on Science n Research n Scientific Literature Review n Developing Research Recommendations n Testing and Test Method Development n Guidelines and Standards Collaboration is Essential

Russell D. Owen, Ph.D. FDA Collaborators in RF

Russell D. Owen, Ph.D. FDA Activities n Long Term Animal Studies n Exposure Assessment n Test Method Development n Cellular and Animal Experiments on Enzyme Activity n Assessments and Education n Cooperative Research Program

Russell D. Owen, Ph.D.

Cooperative Research Program Supplements FDA Science Activities n Cooperative Research and Development Agreement with the Cellular Telephone and Internet Association n FDA Provides Scientific and Technical Oversight n Three Parts u Micronucleus Assay u Epidemiology u Other Topics

Russell D. Owen, Ph.D. Into the Future n Research to Fill Data Gaps n Continual Assessment n Safety Measures Based on Science