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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 radio frequency 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.
a777.book Page 145 Friday, September 26, 2008 4:08 PM