cancer-causing chemicals so as to be pre-disposed to develop cancer in 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 phones 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 ten 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 radio frequency 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.

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GH68-21438A specifications

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