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Sendo X Manual

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Regulatory Compliance and SAR
176 Sendo X User Guide
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 necessary
2
.
FDA is currently working with government, industry,
and academic groups to ensure the proper follow-
up 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 noted
among more than 20 variables compared
3
.
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 significant
4
.
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.
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
… 182 …


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