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58 Appendix Appendix 59
that any health problems are associated with
using wireless phones. There is no proof, however,
that wireless phones are absolutely safe. Wireless
phones emit low levels of radiofrequency energy
(RF) in the microwave range while being used.
They also emit very low levels of RF when in the
standby mode. Whereas high levels of RF can pro-
duce health effects (by heating tissue), exposure to
low level RF that does not produce heating effects
causes no known adverse health effects. Many
studies of low level RF exposures have not found
any biological effects. Some studies have suggest-
ed that some biological effects may occur, but such
findings have not been confirmed by additional
research. In some cases, other researchers have had
difficulty in reproducing those studies, or in deter-
mining the reasons for inconsistent results.
3. What is FDA’s role concerning the safety of
wireless phones?
Under the law, FDA does not review the safety of
radiation-emitting consumer products such as wire-
less phones before they can be sold, as it does with
new drugs or medical devices. However, the agen-
cy has authority to take action if wireless phones
are shown to emit radiofrequency energy (RF) at a
level that is hazardous to the user. In such a case,
FDA could require the manufacturers of wireless
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, FDA has urged the wireless
phone industry to take a number of steps, includ-
ing the following:
•
Support needed research into possible biologi-
cal effects of RF of the type emitted by wireless
phones;
•
Design wireless phones in a way that minimizes
any RF exposure to the user that is not neces-
sary for device function; and
•
Cooperate in providing users of wireless phones
with the best possible information on possible
effects of wireless phone use on human health
FDA belongs to an interagency working group
of the federal agencies that have responsibil-
ity for different aspects of RF safety to ensure
coordinated efforts at the federal level. The fol-
lowing agencies belong to this working group:
•
National Institute for Occupational Safety and
Health
•
Environmental Protection Agency
•
Federal Communications Commission
•
Occupational Safety and Health
Administration
•
National Telecommunications and
Information Administration
The National Institutes of Health participates in
some interagency working group activities, as well.
FDA shares regulatory responsibilities for wire-
less phones with the Federal Communications
Commission (FCC).
All phones that are sold in the United States must
comply with FCC safety guidelines that limit RF
exposure.
FCC relies on FDA and other health agencies for
safety questions about wireless phones.
FCC also regulates the base stations that the wire-
less phone networks rely upon. While these base
stations operate at higher power than do the
wireless phones themselves, the RF exposures that
people get from these base stations are typically
thousands of times lower than those they can get
from wireless phones. Base stations are thus not
the primary subject of the safety questions dis-
cussed in this document.
4. What are the results of the research done
already?
The research done thus far has produced conflict-
ing results, and many studies have suffered from
flaws in their research methods. Animal experi-
ments investigating the effects of radiofrequency
energy (RF) exposures characteristic of wireless
phones have yielded conflicting results that often
cannot be repeated in other laboratories. A few
animal studies, however, have suggested that low
levels of RF could accelerate the development of
cancer in laboratory animal.
5. What research is needed to decide whether RF
exposure from wireless phones poses a health
risk?
A combination of laboratory studies and epide-
miological studies of people actually using wireless
phones would provide some of the data that are
needed. Lifetime animal exposure studies could be
completed in a few years.
However, very large numbers of animals would
be needed to provide reliable proof of a cancer
promoting effect if one exists. Epidemiological
studies can provide data that is directly applicable
to human populations, but 10 or more years’ fol-
low-up may be needed to provide answers about
some health effects, such as cancer. This is because
the interval between the time of exposure to a
cancer-causing agent and the time tumors develop
- if they do - may be many, many years. The inter-
pretation of epidemiological studies is hampered
by difficulties in measuring actual RF exposure
during day-to-day use of wireless phones. Many
factors affect this measurement, such as the angle
at which the phone is held, or which model of
phone is used.
6. What is FDA doing to find out more about the
possible health effects of wireless phone RF?
FDA is working with the U.S. National Toxicology
Program and with groups of investigators around
the world to ensure that high priority animal stud-
ies are conducted to address important questions
about the effects of exposure to radiofrequency
energy (RF).
FDA has been a leading participant in the World
Health Organization International Electromagnetic
Fields (EMF) Project since its inception in 1996. An
influential result of this work has been the devel-
opment of a detailed agenda of research needs
that has driven the establishment of new research