Identification of Research Needs Relating to Potential Biological or Adverse Health Effects of Wireless Communication Devices (2008)

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Introduction The U.S. Food and Drug Administration (FDA) of the Department of Health and Human Services asked the National Academies to organize a workshop of national and international experts to discuss research needs and gaps in our knowledge of the biological effects and adverse health outcomes of exposure to radiofrequency (RF) energy from wireless com- munications devices. Although the sponsor’s main interest centers on hand- held devices such as cell phones or portable home phones, base stations and antennas were also considered by the committee based on discussions with the sponsors indicating that consideration of these components would not be discouraged. The workshop was announced on the National Academies’ Current Projects site, and attendance was available to anyone interested in attending the workshop. This workshop announcement included instructions for sub- mitting written comments for consideration at the workshop. A workshop announcement was also provided to the FDA and the ­Bioelectromagnetics Society for distribution as deemed appropriate, as well as to ­ individuals who expressed an interest in the workshop. It was clear from the presentations and discussions at the workshop that a great deal of research has been accomplished to date, but sometimes with inconsistent results. This workshop, however, was not intended to evaluate health effects, and the report based on a workshop does not assess health effects or make recommendations as to how the identified research needs should be met. The National Academies was asked to issue a report following the workshop that exclusively draws on the workshop 10 

INTRODUCTION 11 presentations and discussions to identify current research needs and gaps in knowledge. The committee was also asked to provide its consensus find- ings on near-, mid-, and long-term research opportunities. The report is a committee product and does not necessarily reflect the views of the FDA, individual workshop speakers, or other workshop participants. To organize the workshop and to identify experts to address research needs and gaps relating to potential biological or adverse health effects of wireless communications devices, the committee (Appendix B) held a workshop planning meeting on July 9-10, 2007. As a result of this plan- ning meeting, international experts from 9 countries were invited to speak at the workshop. Written contributions on research needs and gaps for the committee’s consideration were also solicited for submission prior to the workshop, which was held on August 7-9, 2007. A total of 16 writ- ten contributions were received from individuals listed in Appendix E. The ­speakers’ presentations, panel discussions, comments from interested workshop attendees, and written contributions were considered by the com- mittee as it developed this report. The workshop itself was organized into six sessions (Appendix C). The first five sessions consisted of invited participants and panel discussions that identified research needs and gaps in the following areas: • exposure and dosimetry, • epidemiology, • human laboratory studies, • mechanisms, and • animal and cell biology. A sixth session, which was held on the morning of the third day, intro- duced overarching issues and solicited research needs from speakers and other interested participants. Overarching issues were determined by the committee at the workshop planning meeting held in July 2007. The pur- pose of the sixth session was to make sure that research needs that might reach across the disciplines were discussed and identified. The issues were thus designed to address current topics in RF research. A short introduc- tion of each subject was made by a committee member and unrestricted input was then invited from interested parties attending the workshop. The overarching issues were as follows: • Are there differences in health effects of short-term vs. long-term exposure? • Are there differences between local vs. whole-body exposures? • Can the knowledge of biological effects from current signal types and exposure patterns be extrapolated to emerging exposure scenarios? 

12 IDENTIFICATION OF RESEARCH NEEDS • Are there any biological effects that are not caused by an increase in tissue temperature (nonthermal effects)? • Does RF exposure alter (synergize, antagonize, or potentiate) the biological effects of other chemical or physical agents? • Are there differences in risk to children? • Are there differences in risk to other subpopulations such as the elderly and individuals with underlying disease states? These overarching issues and the general discussions that followed were factored into the committee’s deliberations in developing the report. From the presentations and discussions that took place at the workshop sessions, the committee identified research needs and gaps; the selection of these research needs and gaps are committee judgments. For the purposes of this report, the committee defines research needs as research that will increase our understanding of the potential adverse effects of RF energy on humans.  Research gaps are defined as areas of research where the committee judges that scientific data that have potential value are presently lacking, but that ���������������������������������������������� closing of these gaps is ongoing, and results should be awaited before judgments are made on further research needs, or the gaps are������������������������������������������������������������ ����������������������������������������������������������� not judged by the committee to be of as high a priority at this time. To the extent possible, near-, mid-, and long-term research opportuni- ties have been characterized as follows: the committee judged that research needs are near-term research opportunities. Gaps that are currently being filled may result in mid-term research opportunities, depending on the out- come of the current research. Gaps defined as being of lower priority with ����� respect to ���������������������������������������������������������������� directly addressing health concerns����������������������������� ���������������������������� comprise possible long-term research opportunities.   Synergize: two or more agents or forces interacting so that their combined effect is greater than the sum of their individual effects. Antagonize: two or more agents or forces interacting so that one agent counteracts the effect of another agent. Potentiate: one agent promotes or strengthens a biochemical or physiological action or effect of another agent.