User guide

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 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 informa-
tion 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 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 devel-
oped 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
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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 conflicting results and many studies have
suffered from flaws in their research methods. Animal experiments 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 acceler-
ate the development of cancer in laboratory animals.
However, many of the studies that showed increased tumor development used
animals that had been genetically engineered or treated with cancer-causing
chemicals so as to be predisposed to develop cancer in the absence of RF exposure.
Other studies exposed the animals to RF for up to 22 hours per day. These condi-
tions are not similar to the conditions under which people use wireless phones,
so we don’t know with certainty what the results of such studies mean for human
health. Three large epidemiology studies have been published since December
2000. Between them, the studies investigated any possible association between the
use of wireless phones and primary brain cancer, glioma, meningioma or acoustic
neu-roma, tumors of the brain or salivary gland, leukemia or other cancers. None of
the studies demonstrated the existence of any harmful health effects from wireless
phone RF exposures. However, none of the studies can answer questions about
long-term exposures, since the average period of phone use in these studies was
around three years.
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 needed. 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 promot-
ing 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 inter-
val 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 epidemiologi-
cal 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 inves-
tigators 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
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