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being used. They also emit very low levels of RF when in
the stand-by mode. Whereas high levels of RF can produce
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 suggested 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 determining
the reasons for inconsistent results.
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Under the law, FDA does not review the safety of
radiation-emitting consumer products such as wireless
phones before they can be sold, as it does with new drugs
or medical devices. However, the agency 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, including the following:
- Support needed research into possible biological 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 necessary 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 responsibility for different aspects of RF
safety to ensure coordinated efforts at the federal level. The
following 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 wireless 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 wireless
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
discussed in this document.
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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).
252918356_LU_ME2006a_OT4x8 RF_US_en.book Page 31 Mercredi, 28. février 2007 9:02 09