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US SAR Statement pages

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15
RF and FDA/FCC Statements
government-adopted requirement for safe
exposure. The tests are performed in positions and
locations (for example, at the ear and worn on the
body) as approved by the FCC and Industry
Canada for each model. The highest SAR value for
this model phone as reported to the FCC and
available for review by Industry Canada when
tested for use at the ear is 1.296 W/kg, and when
worn on the body, as described in this user guide,
is 1.034 W/kg. (Body-worn measurements differ
among phone models, depending upon available
accessories and FCC requirements.) While there
may be differences between the SAR levels of
various phones and at various positions, they all
meet the government requirement.
The FCC and Industry Canada have granted an
Equipment Authorization for this model phone with
all reported SAR levels evaluated as in compliance
with the FCC RF exposure guidelines. SAR
information on this model phone is on file with the
FCC and can be found under the Display Grant
section of http://www.fcc.gov/oet/fccid after
searching on FCC ID:P6PSND100, Industry
Canada ID: IC:4279A-SND100 or MET Listing
no:E112302. For body-worn operation, to maintain
compliance with FCC RF exposure guidelines, use
only Sendo-approved accessories. When carrying
the phone while it is on, place the phone in the
original Sendo carry case that has been tested for
compliance.
Use of non-Sendo-approved accessories may
violate FCC RF exposure guidelines and should be
avoided.
*In the United States and Canada, the SAR limit for
mobile phones used by the public is 1.6 watts/kg
(W/kg) averaged over one gram of tissue and
allows for testing and other tolerances. The
standard incorporates a substantial margin of
THIS MODEL PHONE MEETS THE
GOVERNMENT’S REQUIREMENTS FOR
EXPOSURE TO RADIO WAVES.
Your wireless phone is a radio transmitter and
receiver. It is designed and manufactured not to
exceed the emission limits for exposure to radio
frequency (RF) energy set by the Federal
Communications Commission of the U.S.
Government and by Health Canada. These limits
are part of comprehensive guidelines and establish
permitted levels of RF energy for the general
population. The guidelines are based on standards
that were developed by independent scientific
organizations through periodic and thorough
evaluation of scientific studies. The standards
include a substantial safety margin designed to
assure the safety of all persons, regardless of age
and health. The exposure standard for wireless
mobile phones employs a unit of measurement
known as the Specific Absorption Rate, or SAR. The
SAR limit set by the FCC and Health Canada is
1.6W/kg.* Tests for SAR are conducted using
standard operating positions accepted by the FCC
and Industry Canada with the phone transmitting at
its highest certified power level in all tested
frequency bands. Although the SAR is determined
at the highest certified power level, the actual SAR
level of the phone while operating can be well
below the maximum value. This is because the
phone is designed to operate at multiple power
levels so as to use only the power required to reach
the network. In general, the closer you are to a
wireless base station antenna, the lower the power
output.
Before a phone model is available for sale to the
public in the US and Canada, it must be tested and
certified to the FCC and Industry Canada that it
does not exceed the limit established by the
45
RF and FDA/FCC Statements
Radio frequency (RF) signals
15
RF and FDA/FCC Statements
15
safety to give additional protection for the public
and to account for any variations in measurements.
What kinds of phones are in question?
Questions have been raised about hand-held
mobile phones, the kind that have a built-in antenna
that is positioned close to the user’s head during
normal telephone conversation. These types of
mobile phones are of concern because of the short
distance between the phone’s antenna—the
primary source of the RF— and the person’s head.
The exposure to RF from mobile phones in which
the antenna is located at greater distances from the
user (on the outside of a car, for example) is
drastically lower than that from hand-held phones,
because a person’s RF exposure decreases
rapidly with distance from the source. The safety of
so-called "cordless phones," which have a base
unit connected to the telephone wiring in a house
and which operate at far lower power levels and
frequencies, has not been questioned.
The U.S. Food and Drug
Administration’s Center for
Devices and Radiological Health
Consumer Update on Mobile Phones
FDA has been receiving inquiries about the safety
of mobile phones, including cellular phones and
PCS phones. The following summarizes what is
known—and what remains unknown—about
whether these products can pose a hazard to
health, and what can be done to minimize any
potential risk. This information may be used to
respond to questions.
Why the concern?
Mobile phones emit low levels of radiofrequency
energy (i.e. radiofrequency radiation) in the
microwave range while being used. They also emit
very low levels of radiofrequency energy (RF),
considered non-significant, when in the stand-by
mode. It is well known that high levels of RF can
produce biological damage through heating effects
(this is how your microwave oven is able to cook
food). However, it is not known whether, to what
extent, or through what mechanism, lower levels of
RF might cause adverse health effects as well.
Although some research has been done to address
these questions, no clear picture of the biological
effects of this type of radiation has emerged to
date. Thus, the available science does not allow us
to conclude that mobile phones are absolutely safe,
or that they are unsafe. However, the available
scientific evidence does not demonstrate any
adverse health effects associated with the use of
mobile phones.
How much evidence is there that hand-held mobile
phones might be harmful?
Briefly, there is not enough evidence to know for
sure, either way; however, research efforts are ongoing. The existing scientific evidence is conflicting
and many of the studies that have been done to
date have suffered from flaws in their research
methods. Animal experiments investigating the
effects of RF exposures characteristic of mobile
phones have yielded conflicting results. A few
animal studies, however, have suggested that low
levels of RF could accelerate the development of
cancer in laboratory animals. In one study, mice
genetically altered to be predisposed to
developing one type of cancer developed more
than twice as many such cancers when they were
exposed to RF energy compared to controls. There
is much uncertainty among scientists about
whether results obtained from animal studies apply
to the use of mobile phones. First, it is uncertain
how to apply the results obtained in rats and mice
46
15
exposure to mobile phone RF on genetic
material. These included tests for several kinds
of abnormalities, including mutations,
chromosomal aberrations, DNA strand breaks,
and structural changes in the genetic material of
blood cells called lymphocytes. None of the
tests showed any effect of the RF except for the
micronucleus assay, which detects structural
effects on the genetic material. The cells in this
assay showed changes after exposure to
simulated cell phone radiation, but only after 24
hours of exposure. It is possible that exposing
the test cells to radiation for this long resulted in
heating. Since this assay is known to be
sensitive to heating, heat alone could have
caused the abnormalities to occur. The data
already in the literature on the response of the
micronucleus assay to RF are conflicting. Thus,
follow-up research is necessary2.
FDA is currently working with government, industry,
and academic groups to ensure the proper followup to these industry-funded research findings.
Collaboration with the Cellular Telecommunications
Industry Association (CTIA) in particular is
expected to lead to FDA providing research
recommendations and scientific oversight of new
CTIA-funded research based on such
recommendations.
Two other studies of interest have been reported
recently in the literature:
1 Two groups of 18 people were exposed to
simulated mobile phone signals under
laboratory conditions while they performed
cognitive function tests. There were no changes
in the subjects’ ability to recall words, numbers,
or pictures, or in their spatial memory, but they
were able to make choices more quickly in one
visual test when they were exposed to simulated
mobile phone signals. This was the only change
For the past five years in the United States, the
mobile phone industry has supported research into
the safety of mobile phones. This research has
resulted in two findings in particular that merit
additional study:
1 In a hospital-based, case-control study,
researchers looked for an association between
mobile phone use and either glioma (a type of
brain cancer) or acoustic neuroma (a benign
tumor of the nerve sheath). No statistically
significant association was found between
mobile phone use and acoustic neuroma. There
was also no association between mobile phone
use and gliomas when all types of types of
gliomas were considered together. It should be
noted that the average length of mobile phone
exposure in this study was less than three years.
When 20 types of glioma were considered
separately, however, an association was found
between mobile phone use and one rare type of
glioma, neuroepithelliomatous tumors. It is possible
with multiple comparisons of the same sample that
this association occurred by chance. Moreover, the
risk did not increase with how often the mobile
phone was used, or the length of the calls. In fact,
the risk actually decreased with cumulative hours of
mobile phone use. Most cancer-causing agents
increase risk with increased exposure. An ongoing
study of brain cancers by the National Cancer
Institute is expected to bear on the accuracy and
repeatability of these results1.
2 Researchers conducted a large battery of
laboratory tests to assess the effects of
47
RF and FDA/FCC Statements
to humans. Second, many of the studies that
showed increased tumor development used
animals that had already been treated with cancercausing chemicals, and other studies exposed the
animals to the RF virtually continuously—up to 22
hours per day.
RF and FDA/FCC Statements
15
noted among more than 20 variables
compared3.
2 In a study of 209 brain tumor cases and 425
matched controls, there was no increased risk of
brain tumors associated with mobile phone use.
When tumors did exist in certain locations,
however, they were more likely to be on the side
of the head where the mobile phone was used.
Because this occurred in only a small number of
cases, the increased likelihood was too small to
be statistically significant4.
In summary, we do not have enough information at
this point to assure the public that there are, or are
not, any low incident health problems associated
with use of mobile phones. FDA continues to work
with all parties, including other federal agencies
and industry, to assure that research is undertaken
to provide the necessary answers to the
outstanding questions about the safety of mobile
phones.
form of cancer is greater among people who use
mobile phones than among the rest of the
population. One way to answer that question is to
compare the usage of mobile phones among
people with brain cancer with the use of mobile
phones among appropriately matched people
without brain cancer. This is called a case-control
study. The current case-control study of brain
cancers by the National Cancer Institute, as well as
the follow-up research to be sponsored by industry,
will begin to generate this type of information.
What is FDA’s role concerning the safety of mobile
phones?
Under the law, FDA does not review the safety of
radiation-emitting consumer products such as
mobile phones before marketing, as it does with
new drugs or medical devices. However, the
agency has authority to take action if mobile
phones are shown to emit radiation at a level that is
hazardous to the user. In such a case, FDA could
require the manufacturers of mobile phones to
notify users of the health hazard and to repair,
replace or recall the phones so that the hazard no
longer exists. Although the existing scientific data
do not justify FDA regulatory actions at this time,
FDA has urged the mobile phone industry to take a
number of steps to assure public safety. The
agency has recommended that the industry:
support needed research into possible biological
effects of RF of the type emitted by mobile phones;
Design mobile phones in a way that minimizes any
RF exposure to the user that is not necessary for
device function; and
cooperate in providing mobile phone users with the
best possible information on what is known about
possible effects of mobile phone use on human
health.
What is known about cases of human cancer that
have been reported in users of hand-held mobile
phones?
Some people who have used mobile phones have
been diagnosed with brain cancer. But it is
important to understand that this type of cancer
also occurs among people who have not used
mobile phones. In fact, brain cancer occurs in the
U.S. population at a rate of about 6 new cases per
100,000 people each year. At that rate, assuming
80 million users of mobile phones (a number
increasing at a rate of about 1 million per month),
about 4800 cases of brain cancer would be
expected each year among those 80 million
people, whether or not they used their phones.
Thus it is not possible to tell whether any
individual’s cancer arose because of the phone, or
whether it would have happened anyway. A key
question is whether the risk of getting a particular
48
15
a hand-held phone with a built in antenna
connected to a different antenna mounted on the
outside of the car or built into a separate package,
or
a headset with a remote antenna to a mobile phone
carried at the waist.
Again, the scientific data do not demonstrate that
mobile phones are harmful. But if people are
concerned about the radiofrequency energy from
these products, taking the simple precautions
outlined above can reduce any possible risk.
Where can I find additional information?
For additional information, see the following
websites:
Federal Communications Commission (FCC) RF
Safety Program (select "Information on Human
Exposure to RF Fields from Cellular and PCS Radio
Transmitters"):
http://www.fcc.gov/oet/rfsafety
World Health Organization (WHO) International
Commission on Non-Ionizing Radiation Protection
(select Qs & As):
http://www.who.int/emf
United Kingdom, National Radiological Protection
Board:
http://www.nrpb.org.uk
Cellular Telecommunications Industry Association
(CTIA):
http://www.wow-com.com
U.S. Food and Drug Administration (FDA) Center
for Devices and Radiological Health:
http://www.fda.gov/cdrh/consumer/
In the absence of conclusive information about any
possible risk, what can concerned individuals do?
If there is a risk from these products—and at this
point we do not know that there is—it is probably
very small. But if people are concerned about
avoiding even potential risks, there are simple
steps they can take to do so. For example, time is a
key factor in how much exposure a person
receives. Those persons who spend long periods of
time on their hand-held mobile phones could
consider holding lengthy conversations on
conventional phones and reserving the hand-held
models for shorter conversations or for situations
when other types of phones are not available.
People who must conduct extended conversations
in their cars every day could switch to a type of
mobile phone that places more distance between
their bodies and the source of the RF, since the
exposure level drops off dramatically with distance.
For example, they could switch to
a mobile phone in which the antenna is located
outside the vehicle,
1 Muscat et al. Epidemiological Study of Cellular
Telephone Use and Malignant Brain Tumors. In:
49
RF and FDA/FCC Statements
At the same time, FDA belongs to an interagency
working group of the federal agencies that have
responsibility for different aspects of mobile phone
safety to ensure a coordinated effort at the federal
level. These agencies are:
 National Institute for Occupational Safety and
Health
 Environmental Protection Agency
 Federal Communications Commission
 Occupational Health and Safety Administration
 National Telecommunications and Information
Administration
The National Institute of Health also participates in
this group.
RF and FDA/FCC Statements
15
State of the Science Symposium;1999 June 20;
Long Beach, California.
2 Tice et al. Tests of mobile phone signals for
activity in genotoxicity and other laboratory assays.
In: Annual Meeting of the Environmental Mutagen
Society; March 29, 1999, Washington, D.C.; and
personal communication, unpublished results.
3 Preece, AW, Iwi, G, Davies-Smith, A, Wesnes, K,
Butler, S, Lim, E, and Varey, A. Effect of a 915-MHz
simulated mobile phone signal on cognitive
function in man. Int. J. Radiat. Biol., April 8, 1999.
4 Hardell, L, Nasman, A, Pahlson, A, Hallquist, A
and Mild, KH. Use of cellular telephones and the
risk for brain tumors: a case-control study. Int. J.
Oncol., 15: 113-116, 1999.
50

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