FDA CONSUMER UPDATE
SAFETY AND WARRANTY
6. What is FDA doing to find out more about the possible health
effects of wireless handset 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 studies 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 development of a detailed
agenda of research needs that has driven the establishment of new
research programs around the world. The Project has also helped
develop a series of public information documents on EMF issues. FDA
and the Cellular Telecommunications & Internet Association (CTIA) have
a formal Cooperative Research and Development Agreement (CRADA) to
do research on wireless handset safety. FDA provides the scientific
oversight, obtaining input from experts in government, industry, and
academic organizations. CTIA-funded research is conducted through
contracts to independent investigators. The initial research will include
both laboratory studies and studies of wireless handset users. The CRADA
will also include a broad assessment of additional research needs in the
context of the latest research developments around the world.
7. How can I find out how much radiofrequency energy exposure
I can get by using my wireless handset?
All handsets sold in the United States must comply with Federal
Communications Commission (FCC) guidelines that limit radiofrequency
energy (RF) exposures. FCC established these guidelines in consultation
with FDA and the other federal health and safety agencies. The FCC limit
for RF exposure from wireless devices is set at a Specific Absorption Rate
(SAR) of 1.6 watts per kilogram (1.6 W/kg). The FCC limit is
consistent with the safety standards developed by the Institute of
Electrical and Electronic Engineering (IEEE) and the National Council on
Radiation Protection and Measurement. The exposure limit takes into
consideration the body’s ability to remove heat from the tissues that
absorb energy from the wireless handset and is set well below levels
known to have effects. Manufacturers of wireless handsets must report
the RF exposure level for each model of handset to the FCC. The FCC
website (http://www.fcc.gov/oet/rfsafety) gives directions for locating the
FCC identification number on your handset so you can find your hand-
set’s RF exposure level in the online listing.
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FDA CONSUMER UPDATE
4. What are the results of the research done already?
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 handsets 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 predisposed 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 handsets, so we don’t know with certainty what the results
of such studies mean for human health. Three large epidemiology stud-
ies have been published since December 2000. Between them, the studies
investigated any possible association between the use of wireless hand-
sets and primary brain cancer, glioma, meningioma, or acoustic neu-
roma, 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 handset RF exposures. However, none of the studies
can answer questions about long-term exposures, since the average peri-
od of handset use in these studies was around three years.
5. What research is needed to decide whether RF exposure from
wireless handsets poses a health risk?
A combination of laboratory studies and epidemiological studies of
people actually using wireless handsets 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
difficulties in measuring actual RF exposure during day-to-day use of
wireless handsets. Many factors affect this measurement, such as the
angle at which the handset is held, or which model of handset is used.
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