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REGULATORY INFORMATION
254
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 well within the FCC's
compliance limits.
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
accelerate 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 pre-disposed to
develop cancer in the absence of RF exposure. Other studies
exposed the animals to RF for up to 22 hours per day. These
conditions 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 neuroma,
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.
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 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.
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 organizations. CTIA-funded
research is conducted through contracts to independent
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.