User's Manual

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•SAFETY
2. 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 scientic
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 eects 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 eects of wireless phone use on human health.
FDA belongs to an interagency working group of the federal agencies that have
responsibility for dierent aspects of RF safety to ensure coordinated eorts 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 inter-agency 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 subject of the safety questions discussed in this
document.
3. What kinds of phones are the subject of this update?
The term “wireless phone refers here to hand-held wireless phones with built-in
antennas, often called cell, “mobile, or “PCS phones. These types of wireless
phones can expose the user to measurable radiofrequency energy (RF) because
of the short distance between the phone and the user’s head. These RF exposures
are limited by Federal Communications Commission safety guidelines that were
developed with the advice of FDA and other federal health and safety agencies.
When the phone is located at greater distances from the user, the exposure to
RF is drastically lower because a person’s RF exposure decreases rapidly with
increasing distance from the source. The so-called cordless phones, which have
a base unit connected to the telephone wiring in a house, typically operate at far
lower power levels, and thus produce RF exposures far below the FCC safety limits.
4. What are the results of the research done already?
The research done thus far has produced conicting results, and many studies
have suered from aws in their research methods. Animal experiments
investigating the eects of radiofrequency energy (RF) exposures characteristic of
wireless phones have yielded conicting results that often cannot be repeated in
other laboratories. A few animal studies, however, have suggested that low levels