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A P P E N D I X
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 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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