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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 non-thermal mechanisms or
whether they produce cumulative effects. We have included a summary of
some recent studies in the enclosed Appendix.
QUESTIONS
1. (a) What type of scientific research is
needed to fully assess whether RF exposure from wireless phones pose a
health risk to consumers? (b) What research is the WTR conducting? Is
this the type of research that is necessary to fully assess whether RF
exposure from wireless phones pose a health risk to consumers?
(a) In order to assess whether RFR exposure
from wireless phones poses a health risk to consumers, a combination of
laboratory studies, and epidemiological studies of human populations
actually using cellular phones is needed. Laboratory studies should
include engineering and dosimetric (measurement of dosage) studies of
the amount of radiation absorbed in the heads and bodies of wireless
phone users, including the ways in which this energy deposition is
affected by the users' anatomy, objects such as eyeglasses and jewelry,
and the design of the phone itself. Bioeffects studies should include
the development of in vitro and
in vivo exposure systems, and the use of
these systems in cellular and short and long-term animal
studies to determine mechanisms of action. Both epidemiological studies
and continued postmarket surveillance of exposed human populations are
critical.
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 long-term
exposure). A summary of experiments (with short and long-term exposure).
A summary of the WTR research agenda prepared by CDRH is provided in TAB
B.
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).
2. To your knowledge, is the WTR conducting any
biomedical research to assess whether the frequencies and power levels
utilized by portable wireless cellular phones produce RF exposure that
is unsafe to consumers? If so, please provide a description of such
research.
To the best of our knowledge, the research
conducted by WTR to date falls into the categories of exposure system
development and epidemiological studies. In addition, WTR has devoted
much effort to an assessment of the existing research data and the
planning of a comprehensive program. The WTR program of exposure system
development has led to the design exposure systems for use in both
animal studies and studies of cultured cells in
vitro. WTR's efforts to design exposure systems that will
accurately deliver known levels of RFR to animals and cells
in vitro is expected to be valuable to the
scientific community.
WTR's epidemiological studies of populations using cellular phones is
expected to yield potentially valuable human data, but the studies that
can address potential long-term effects will require a
number of years. We are not currently able to state when the WTR program
will lead to conclusive information, but we believe that it will require
an ongoing research effort beyond the current five year program.
3. Is the FDA fully confident that the research
being conducted by the WTR has the independence and scientific
integrity to assess adequately portable wireless phone safety? In your
opinion, can the Federal government, and American consumers, rely on
the results of this industry-sponsored research?
As stated, FDA's role in the WTR research
program has been in a scientific advisory capacity. The Agency has no
information which would lead us to believe that the Federal Government
and the American consumers will not be able to rely on the results of
the WTR research. The research agenda was subjected to peer review
coordinated by the Harvard University School of Public Health Center for
Risk Analysis. As with all scientific research, research results also
will be expected to undergo the rigors of a scientific peer review as
part of the publication process.
4. What research has been conducted at any
Federal agency since 1993 to assess whether the frequencies and power
levels utilized by portable wireless phones produce RF exposure that
is unsafe to consumers? Please list the agencies, types of research,
and expected dates for completion of such research. If no such
research has been, or is being conducted, please explain why not.
To the best of our knowledge, there is no
current large scale research effort underway by the Federal agency to
assess the frequencies and power levels utilized by portable wireless
phones. The National Cancer Institute (NCI), however, has included
wireless communication use in its comprehensive study of brain tumor
associations with environmental factors. The study has been underway
since 1994, with reports on the findings expected to appear in the fall
of 1999. The cost of the entire study is approximately $2.2 million, but
it is not possible to ascertain separately the cost of the component
focusing on cellular phone use. In addition, CDRH has performed both
experimental and computational investigations of the energy deposition
in the body from cellular phones. Finally, NIOSH has conducted RFR
research involving laboratory studies, instrumentation development, and
field studies. This research, however, has concentrated on equipment and
situations where the strongest occupational exposures to RFR are known
to occur, i.e., with workers using RF heaters and other industrial
equipment, and maintenance workers of broadcast RF antennas. NIOSH has
not conducted any studies specifically addressing the health effects of
cellular telephone use.
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.
5. Has the Federal government sponsored or
funded any outside research since 1993 that specifically analyzes
whether the frequencies and power levels utilized by portable wireless
phone produce RF exposure that is unsafe to consumers? Please list the
organization conducting such research, the amount of Federal support,
and the expected dates for completion of such research. If no such
research has been, or is being conducted or funded, please explain why
not.
To the best of our knowledge, there is no
Federal Government sponsored research specifically directed toward
cellular phone safety. EPA is sponsoring a study by the National Council
on Radiation Production and Measurement (NCRP) on the impact of signal
modulation on the effective RFR dose delivered to tissue. The NCRP
study, started in 1995 and expected to be completed in 1997, is funded
at a level of $100,00 by EPA's Office of Radiation and Indoor Air.
Although not directed specifically toward cellular phone safety, the
information developed by this study is expected to be useful in several
facets of RFR research, including wireless communications. This study is
necessary to help determine, for instance, whether the exposures from
digital phones are biologically equivalent to those from analog phones
with the same time-averaged energy deposition.
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.
6. Since 1993, has the Federal government
conducted any research itself, received any research data from the WTR,
or received any outside research results, that serve to reassure the
public that portable wireless phones are safe? If so, please describe
such research.
To the best of our knowledge, there have been
no definitive research results since 1993 that can serve to completely
reassure the public that portable wireless phone are safe. As noted in
the Appendix, Rothman et al. (Rothman, et al. 1996. Epidemiology;
7:303-305) conducted an epidemiological study, that was sponsored by WTR
and published in 1996, of more than 250,000 portable and mobile
telephone users. Overall mortality rates of cellular phone users were
reported to be less than that of the corresponding rates for the general
population, a finding that may be related to the socioeconomic status of
cellular phone users. No significant difference was observed in the
mortality rate ratio for portable vs. mobile cellular phone users. Users
of hand-held cellular phones have a higher exposure to RFR than do users
of mobile cellular phones. As a general rule, there is a relatively long
latency period between exposure to a carcinogen and the diagnosis of a
tumor, e.g., asbestos exposure and mesothelioma. In the Rothman study,
the period between exposure to cellular phones and the ascertainment of
mortality of study participants was relatively brief, and less than the
latency period of many carcinogens. Therefore, the Rothman study does
not rule out the possibility of a long-term relationship between
cellular phones and cancer. Continued follow-up of the study
participants is warranted. The possible relationship between cellular
phone use and specific causes of mortality, such as brain cancer, also
was not addressed by the study.
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).
7. Since 1993, has the Federal government
conducted any research itself, received any research data from the WTR,
or received any outside research results, that serve to diminish
confidence that portable wireless phones are safe? If so, please
describe such research.
To the best of our knowledge, there have been
no definitive research results since 1993 that serve to diminish
confidence that portable wireless phones are safe. The Lai-Singh study
(see Appendix) has generated considerable scientific interest among RFR
bioeffects researchers, and is often cited as evidence of potentially
adverse effects of RFR exposure.
8. When does the FDA expect to be able to make
any conclusive statements about health risks associated with RF
exposure from portable wireless phone use?
It is difficult to predict when conclusive
statements about health risks can be made. If we rely on epidemiological
studies alone, data may not be available for many years because there is
a relatively long latency period between exposure to a carcinogen and
the diagnosis of a tumor. Earlier, indirect evidence on risks can be
obtained through animal and cellular studies. This illustrates why the
best approach includes both epidemiological and experimental studies. It
is encouraging to note that this subject is receiving world-wide
research attention.
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
Enclosures
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:
- Chronic (lifetime) animal exposures should be given highest
priority.
- Chronic animal exposures should be performed both with and without
the application of chemical initiating agents to investigate tumor
promotion in addition to tumorigenesis.
- Identification of potential risks should include endpoints other
than brain cancer (e.g., ocular effects of radiofrequency radiation
exposure).
- Replication of prior studies demonstrating positive biological
effects work is needed. A careful replication of the Chou and Guy
study (Bioelectromagnetics 13:469-496, 1992) which suggests that
chronic exposure of rats to microwaves is associated with an increase
in tumors would contribute a great deal to the risk identification
process for wireless communication products.
- Genetic toxicology studies should focus on single cell gel studies
of DNA strand breakage and on induction of micronuclei. (These are the
only direct genetoxic effects suggested at this time.) The need to
replicate the Lai and Singh experiments used to demonstrate
microwave-induced DNA strand breakage (Int. J. Radiat. Biol.
69:513-521, 1996) is strengthened by Dr. Lai's recent reports in
scientific meetings that this effort is suppressed by melatonin
exposure.
- Epidemiology studies focused on approaches optimized for hazard
identification are warranted (e.g., case control studies are well
suited to studying rare diseases such as brain cancer).
Due to the latency of some of the health
effects that have been suggested to be associated with exposure to
non-ionizing radiation, long term study is essential to test such
associations. Indeed, we believe that continuing post-marketing
surveillance is important in ensuring the safety of wireless
technologies.
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 long-term animal bioassays by
first initiating subchronic animal exposure studies, with emphasis
placed on the evaluation of signs of tissue-specific toxicity. WTR has
concluded that animal tumor promotion studies should not be used for
human health risk assessment until there is clear evidence of a casual
relationship between RFR and biological effects related to tumor
promotion.
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 adult-onset leukemia. WTR has stated that it will focus
on investigations involving both cohort and case-control
studies. Cohort studies will be used to assess general mortality and
morbidity of cellular phone users, while case-control
studies will focus on the specific types of tumors listed above. WTR
plans to investigate the potential to use the telephone companies'
billing logs to provide a surrogate measure of RFR exposure. They will
then link this exposure data with specific outcome databases in order to
evaluate relevant causes of morbidity and mortality among the cohort.
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 + 32-2-296
83 91) and on the Commission's ISPO site on the Internet]
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