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| Safety and Health Topics > Radiofrequency/Microwave Radiation > FDA Letter Regarding Cellular Phones | ||
| FDA Letter Regarding Cellular Phones | ||
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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville MD 20857 May 5, 1997 The Honorable Edward J. Markey Ranking Minority Member Subcommittee on Telecommunications, Trade, and Consumer Protection Committee on Commerce House of Representatives Washington, D.C. 20515 - 2107 Dear Mr. Markey: This is in response to your letter of April 7, 1997, regarding the status of the Food and Drug Administration's (FDA) oversight and investigation of wireless communication health effects. Little is known about the possible health effects of repeated or long-term exposure to low levels of radiofrequency radiation (RFR) of the types emitted by wireless communications devices. Indeed, much controversy exists within the scientific community regarding the potential for health effects from any type of low-intensity RFR. RFR extends from approximately a few kilohertz (kHz) to 300 gigahertz (GHz) on the electromagnetic spectrum. Cellular phones emit RFR at a frequency of about 824-915 megahertz (MHz). The new Personal Communications Systems (PCS) emit at 1850-1910 MHz. In addition, radar systems emit in a band of 100 MHz and 100 GHz. Many other consumer products emit in this range, e.g., AM radios around 1 MHz, CB radios at 27 MHz, televisions at 50-500 MHz and above, and microwave ovens at 2450 MHz (2.45 GHz). Each frequency may have unique properties in terms of potential bioeffects and it may not be possible to extrapolate results found at one frequency with those of another. The Center for Device and Radiological Health's (CDRH) specific involvement with cellular phones began in early 1993 when the issue of brain cancer and its possible association with cellular phone use was raised via a nationally televised interview with a man who attributed his wife's death from brain cancer to her frequent use of a cellular telephone. In early 993, CDRH requested several meetings with industry to discuss the inadequacy of the data that exists with which to evaluate claims of health risks such as cancer. At the meetings, CDRH presented the need for properly credentialed research, proper labeling, and possible redesigns to address the issues related to potential bioeffects from the radiofrequency energy emitted by hand-held cellular phones. Industry groups represented at the meeting were manufacturers and distributors of cellular phones, communications firms, and related trade associations. In response to an industry request that Federal agencies play a role in directing the necessary research, CDRH offered to explore the possibility of working under a Cooperative Research and Development Agreement. This agreement was ultimately not accepted by the Cellular Telecommunication Industry Association (CTIA) so CDRH's role in the industry program became an advisory one. The overall industry effort has since evolved to the current program manager by Wireless Technology Research, L.L.C. (WTR), which is funded by industry through a blind trust arrangement. WTR published its research agenda and requests for proposals (RFP) in 1994 and 1995. CDRH discussed detailed comments on the RFP with Dr. George Carlo, Chairman of WTR, and his colleagues from WTR. As a result of the oversight briefing with the Subcommittee you chaired in February 1993, the Environmental Protection Agency (EPA), together with CDRH, the National Institute for Occupational Safety and Health (NIOSH), the Occupational Safety and Health Administration (OSHA), the Federal Communications Commission (FCC), and the National Telecommunications Information Agency (NTIA) reconstituted a Radiofrequency Inter-Agency Work Group (RFIAWG) in August 1994 to coordinated issues of concern to these agencies, including monitoring RFR from wireless communication. This group has been instrumental in providing a coordinated Federal response to industry's research as recommended in the 1994 GAO Report entitled, "Status of Research on the Safety of Cellular Phones." WTR met with representatives of the RFIAWG in 1995 and 1996 for the purpose of discussing details of the WTR research plans and progress. In a March 13, 1997 letter (TAB A), CDRH communicated a statement of RFIAWG research priorities to WTR. CDRH solicited input from the RFIAWG in responding to your specific questions. Most of the studies of RFR in the published literature have investigated the biological effects of exposure to radiofrequency radiation characteristic of radar or microwave ovens. Many of the published studies involve acute exposure of animals or cells in vitro to short, intense RFR doses which do not use the frequencies or modulations used for cellular phones. Cellular phone exposures are at lower RFR doses and, due to frequent cellular phone use, are chronic. Higher does exposures are thought to produce effects as a result of increased temperature. It is not known whether lower doses produce bioeffects through QUESTIONS
There is wide agreement within the international scientific community regarding the types of research needed to assess whether RFR from cellular phones poses a health risk to consumers. Research needs have been articulated by a number of groups, including the European Commission1 and the World Health Organization (WHO) which established an International EMF Project and held a meeting in November 1996 to review the status of the science on non-thermal levels of RF exposure and to identify research needs in order to make better health risk assessments. (b) The WTR has developed a research agenda entitled, "Potential Public Health Risks From Wireless Technology: Research Agenda for the Development of Data for Science-Based Decision Making" (Scientific Advisory Group on Cellular Telephone Research, 1994). The agenda proposed a comprehensive risk assessment strategy, including assessment of the existing literature, development of appropriate dosimetry and exposure systems, epidemiology, in vitro genotoxicology, and animal experiments (with short and Progress to date appears to have been focused on assessing the existing literature, developing the research agenda, working on dosimetry and designs for both in vivo and in vitro exposure systems, and conducting an epidemiology study of overall mortality of 250,000 phone users. The type of research proposed by WTR should provide part of the answer to the questions of whether RF exposure from wireless phones poses a health risk to consumers. CDRH recently conveyed to Dr. Carlo at WTR ten recommendations of the RFIAWG as to which elements should be pursued in the near term, given WTR's stated lack of resources to pursue the entire research agenda as a comprehensive program (TAB A).
WTR's epidemiological studies of populations using cellular phones is expected to yield potentially valuable human data, but the studies that can address potential
To address the possible health effects of non-ionizing radiation, Federal agencies have focused research on studies of possible bioeffects of electric and magnetic fields associated with generation, transmission, distribution, and use of electric power. Such research has been given priority over RFR health effects research, in part, because of the Congressional appropriations and research mandate of the Energy Policy Act of 1992.
In addition, we understand that the Department of Defense conducts research on basis bioeffects. A small portion of this program is devoted to studies of low powered exposures with relevance to cellular telephones.
Another study, which has not been published but which has been presented at the June 9-14, 1996 Bioelectromagnetics Society meeting, was conducted for Motorola by Dr. Ross Adey at the Jerry L. Pettis Veterans Administration Hospital and involved lifetime exposure of rats to cellular phone RFR (see Appendix).
In summary, there is currently no specific information that clearly indicates that use of cellular phones is a human health risk. On the other hand, there is not enough information available to permit a determination that there is no health risk. A significant research effort, involving exposures of large numbers of animals to the various types of cellular phone modulation in current on expected use, coupled with epidemiological surveillance of exposed populations, is needed to provide a further basis for risk assessment of these devices. In closing, let us assure you that FDA has a long-standing commitment to protecting the public health from hazards associated with radiation-emitting products. If we may be of any further assistance, please let us know. Sincerely, Diane E. Thompson Associate Commissioner for Legislative Affairs
Repacholi, et al. 1997. Radiation Research, pp. 631-640. A study in the May 1997 issue of the journal Radiation Research reported an increased incidence of lymphoma in mice exposed to the type of RFR emitted by digital cellular phones. In this study, mice that had been genetically engineered to carry a cancer-causing gene were exposed to the RFR for 30 minutes twice a day for up to 18 months. A control group of mice with the same gene were housed and treated in the same way but not exposed to the RFR. In the mice exposed to the RFR, the incidence of cancer of the lymphoid system increased from 22% to 43%. This study makes an important contribution in the area of wireless technology research. However, the mouse assay system used is not well-characterized with respect to its ability to predict carcinogenesis so the results are not extrapolatable to humans, or even to normal mice. Moreover, the results of any single experiment need to be confirmed by repetition in other laboratories before it can be concluded that the results are reliable. In addition, the mice were exposed toe RFR under conditions that may not simulate the type of exposure humans receive. Finally, the type of RFR used in the experiment is the kind emitted by digital cellular phones in Australia. Most cellular phones used in the United States are analog phones so the applicability of this study to American cellular phone users is unknown. Chou, et al. 1992. Bioelectromagnetics, 13:469-496. A frequently cited study was conducted in the early 1980s at the University of Washington for the United States Air Force and is usually referred to as the Guy study. Two groups of 100 rats were used in the study, with one group being exposed to RFR for 22 hours each day for approximately two years. The other group of rats was an unexposed control group. The frequency and modulation of the RFR was different from that used in cellular phones, but the energy deposited in the rats' bodies was similar to the maximum doses in the heads of cellular phone users. Eighteen rats in the exposed group developed tumors, while only five rats in the control group developed tumors. The difference is statistically significant, but the study has never been replicated and it is possible that the results were due to some factor other than RFR exposure. Adey, et al. June 9-14, 1996. Proceedings of the Eighteenth Annual Meeting of the Bioelectromagnetics Society, pp. 27. In a more recent study conducted for Motorola at the Veterans Administration Hospital in Loma Linda, California, rats were exposed to a chemical carcinogen that causes brain tumors and then to an actual cellular phone RFR source. There were slightly fewer brain tumors in the exposed group, but the numbers of animals that developed tumors was not large enough to support a finding that cellular phone RFR protects against tumors. Dr. Adey has reported the experiment at scientific meetings and said it is being repeated with a larger numbers of rats. Lai and Singh. 1996. Int. J. Radiat. Biol., 69:513:521. Another recent study, referred to as the Lai-Singh study, has also aroused considerable interest. In this study rats were exposed for two hours to RFR levels comparable to those received by cellular phone users, though the frequency and modulation of the RFR was different from actual cellular phones. Using a novel technique, the investigators studied cells isolated from the rats' brains and found that rats exposed to RFR has an increased number of DNA strand breaks relative to the unexposed controls. Some scientists have interpreted these results as suggesting a possible mechanism whereby RFR might influence tumor development, but this experiment does not clearly indicate a health hazard. The utility of this assay for genotoxicity testing is currently a subject of interest and investigation. Kues, et al. 1992. Bioelectromagnetics, 13(5):379-393. Cataract is an established bioeffect and thought to be a thermal effect. The blood-aqueous barrier in the eye and effects on the retina have been investigated by Kues and coworkers at Johns Hpokins. They found an increase in blood-aqueous barrier permeability at 2450 MHZ. Most existing data suggests that direct genotoxic effects of RFR are unlikely, however (note the Lai-Singh report above). The Institute for Working Life More recently, there has been interest in effects reported/studied in humans. When some factory workers in Sweden switched from analog to digital cellular phones at work, they reported headaches which apparently went away when they resumed using analog phones. The Institute for Working Life in Sweden is conducting a study examining self reports of headaches and other symptoms as endpoints; however, this type of study is fraught with difficulty given the subjective nature of the symptoms used as endpoints. Rothman, et al. 1996. Epidemiology, 7:303-305. Kenneth Rotham published an epidemiological study, sponsored by WTR, that failed to find an adverse effect on the short-term mortality of cellular phone users. A detailed discussion of this study is provided in the response to question 6. National Cancer Institute The National Cancer Institute is including cellular phone use as a variable in a current study of brain cancer. TAB A DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Services Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 March 13, 1997 George L. Carlo, Ph.D., M.S., J.D. Chairman Wireless Technologies Research, L.L.C. 1711 N Street, N.W. Suite 400 Washington, DC 20036-2811 Dear Dr. Carlo: As the lead federal agency charged with regulation of radiation-emitting consumer products, the Food and Drug Administration (FDA) has followed the progress of your research effort into the possible health effects of wireless technology with great interest. We are continuing to work with the other members of the Radiofrequency Inter-Agency Work Group in order to provide a coordinated set of comments on your program, as was recommended by the U.S. General Accounting Office in their 1994 report to the Chairman of the House Subcommittee on Telecommunications and Finance, Committee on Energy and Commerce. We were pleased that we could participate in your Cellular Telephone Research and Cancer Symposium held in December 1993, and we benefited greatly from the informative briefings you delivered to the Inter-Agency Work Group in March 1995 and August 1996. We are also pleased to give you the suggestions of the Inter-Agency Work Group regarding priorities for the directions your research should take, as you and the Cellular Telecommunications Industry Association have requested. A number of these suggestions have been voiced at our meeting with you, but we would like to take this opportunity to reiterate them here. Our suggestions for research priorities should in no way be construed as a rank ordering of priorities; we simply wish to state some of our views of what a well-balanced program of research should look like. As was noted in the proceedings of your 1993 symposium, "A balance seems best between epidemiological studies, animal studies, and mechanistic studies, even if the last category cannot be extrapolated". Since your resources are limited, we will attempt to offer our views on how your program could be redirected in order to best answer the questions that the regulatory agencies believe are relevant to out concerns. As it is currently planned, the Wireless Technologies Research, L.L.C. (WTR) research program consists of five elements: dosimetry and exposure system issues, epidemiology, in vitro genotoxicology, and rodent bioassays, both chronic and subchronic. We would like to offer the following points that we believe should be considered in deciding, which of these elements to pursue in the near term, given the lack of resources to pursue them as a comprehensive program:
We believe that products of the WTR research program could have lasting benefit to any organization that may conduct research on the possible health effects of exposure to radiation from wireless communications devices. We hope that WTR finds these suggestions helpful as you enter the implementation stage of your biological research. If we can be of further assistance, please don't hesitate to contact me. Sincerely yours, Elizabeth D. Jacobson, Ph.D. Deputy Director for Science Center for Devices and Radiological Health TAB B Wireless Technology Research, L.L.C. Research Agenda Overview Among the initial functions of WTR were to collect, review, and assess available research on the potential effects of RFR, define the areas for which information is needed, and develop a research plan. The resulting research agenda required 15 months to develop, including a seven month review period. The research agenda was subjected to peer review of a Peer Review Board coordinated by the Harvard University School of Public Health Center for Risk Analysis. The risk evaluation research program encompasses a tiered approach to both developing information and placing appropriate weight on specific scientific findings. Tier I studies involve the development of RFR exposure systems relevant to wireless communication instruments, including cellular phones and conduct of toxicology studies in accordance with standard approaches to product safety evaluation. Tier II studies encompass epidemiological evaluations and longitudinal surveillance of cellular telephone users, employing appropriate measures of real life exposures. Tier III studies will address mechanistic issues arising from studies conducted under Tiers I and II which are suggestive of a public health risk. These will consist of in vitro or in vivo mechanistic studies conducted as needed to assist in the interpretation of results from Tier I and Tier II studies. The goal of the Tier I exposure system development is the development of exposure systems for both in vivo and in vitro experiments that appropriately represent actual human exposure conditions and that are, to the degree possible, standardized across investigations. In particular, WTR has decided to develop in vivo exposure systems which produce ratios of head to whole body exposures that are typical of actual human exposures, rather than the more traditional whole body exposures. WTR is coordinating this effort through its Dosimetry Working Group. WTR has chosen to use a single-site facility for all in vitro studies in order to assure consistency across all in vitro studies, as well as to reduce costs associated with facility construction and operation. The central focus of the Tier I toxicology research program is the assessment of potential carcinogenicity of RFR exposure, using the same research paradigm as commonly used for regulatory assessment of the safety of chemical agents. The tests will involve standardized short-term tests for genotoxicity and various long-term animal studies. After learning of Dr. Lai's results suggesting the genotoxicity of RFR in rats' brains, WTR convened an expert panel to review these results and stated that they would repeat this experiment under exposure conditions relevant to human cellular phone exposures. The genotoxicity studies planned by WTR include standard in vitro microbial and mammalian cell mutation assays and a chromosomal aberrations assay using human lymphocytes. The WTR in vivo toxicology program will focus on the collection of information needed to design The Tier II epidemiology studies planned and being undertaken by WTR focus on the following types of malignancies: gliomas, meningiomas, nerve sheath tumors (including acoustic neuromas), parotid gland tumors, and Tier III studies will be planned as part of the evaluation of the data to be obtained from the Tier I and Tier II stuides. Summary prepared by the Center for Devices and Radiological Health 1 "Possible Health Effects Related to the Use of Radiotelephones; Proposals for a Research Program by a European Commission Expert Group," Oct. 1996, A.F. McKinley, editor [available on request to the European Commission, DG XIII.A.1 (fax + |
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