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Appendix
telephones. This test method is now part of a
standard sponsored by the Association for the
Advancement of Medical instrumentation (AAMI).
The final draft, a joint effort by FDA, medical
device manufacturers, and many other groups,
was completed in late 2000. This standard will
allow manufacturers to ensure that cardiac
pacemakers and defibrillators are safe from
wireless phone EMI.
FDA has tested hearing aids for interference from
handheld wireless phones and helped develop a
voluntary standard sponsored by the Institute of
Electrical and Electronic Engineers (IEEE). This
standard specifies test methods and performance
requirements for hearing aids and wireless
phones so that that no interference occurs when
a person uses a compatible phone and a
compatible hearing aid at the same time. This
standard was approved by the IEEE in 2000. FDA
continues to monitor the use of wireless phones
for possible interactions with other medical
devices. Should harmful interference be found to
occur, FDA will conduct testing to assess the
interference and work to resolve the problem.
10. What are the results of the research done
already?
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The research done thus far has produced
conflicting results, and many studies have
suffered from flaws in their research methods.
Animal experiments 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 animals. However, many of the studies
that showed increased tumor development used
animals that had been genetically engineered or
treated with cancer-causing chemicals so as to
be pre-disposed to develop cancer in the absence
of RF exposure. Other studies exposed the
animals to RF for up to 22 hours per day. These
conditions are not similar to the conditions under
which people use wireless phones, so we don t
know with certainty what the results of such
studies mean for human health.
Three large epidemiology studies have been
published since December 2000. Between them,
the studies investigated any possible association
between the use of wireless phones and primary
brain cancer, glioma, meningioma, or acoustic
neuroma, tumors of the brain or salivary gland,
leukemia, or other cancers. None of the studies
demonstrated the existence of any harmful
health effects from wireless phone RF exposures.
However, none of the studies can answer
questions about long-term exposures, since the
average period of phone use in these studies was
around three years.
11. What research is needed to decide whether
RF exposure from wireless phones poses a health
risk?
A combination of laboratory studies and
epidemiological 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 follow-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 interpretation of
epidemiological studies is hampered by
Appendix
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.
12. Which other federal agencies have
responsibilities related to potential RF health
effects?
Additional information on the safety of RF
exposures from various sources can be obtained
from the following organizations.
FCC RF Safety Program:
http://www.fcc.gov/oet/rfsafety/
Environmental Protection Agency (EPA):
http://www.epa.gov/radiation/
Occupational Safety and Health Administration's
(OSHA):
http://www.oshaslc.gov/SLTC/
radiofrequencyradiation/index.html
National Institute for Occupational Safety and
Health (NIOSH):
http://www.cdc.gov/niosh/emfpg.html
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