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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 determin-
ing the reasons for inconsistent results.
3. What is FDAs role concerning the safety of wireless phones?
Under the law, FDA does not review the safety of radiation-emitting con-
sumer 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, includ-
ing 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.
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 experi-
ments investigating the effects of radiofrequency energy (RF) exposures
characteristic of wireless phones 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 animal.
5. What research is needed to decide whether RF exposure from wireless
phones poses a health risk?
A combination of laboratory studies and epidemiological studies of people
actually using wireless phones would provide some of the data that are need-
ed. 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 phones. Many factors affect this measurement, such as the
angle at which the phone is held, or which model of phone is used.
6. What is FDA doing to find out more about the possible health effects of
wireless phone 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 phone safety. FDA provides the scientific oversight,
obtaining input from experts in government, industry, and academic orga-
nizations. CTIA-funded research is conducted through contracts to indepen-
dent investigators. The initial research will include both laboratory studies
and studies of wireless phone users. The CRADA will also include a broad
assessment of additional research needs in the context of the latest research
developments around the world.
Appendix 7978 Appendix
41


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