Panasonic GU87 manual What is FDA’s role concerning the safety of mobile phones?

2.Researchers conducted a large battery of laboratory tests to assess the effect of exposure to mobile phone RF on genetic material. These included tests for several kinds of abnormalities, including mutations, chromosomal aberrations, DNA strand breaks, and structural changes in the genetic material of blood cells called lymphocytes. None of the tests showed any effect from the RF except for the micronucleus assay, which detects structural effects on the genetic material. The cells in this assay showed changes after exposure to simulated cell phone radiation, but only after 24 hours of exposure. It is possible that exposing the test cells to radiation for this long resulted in heating. Since this assay is known to be sensitive to heating, heat alone could have caused the abnormalities to occur. The data already in the literature on the response of

the micronucleus assay to RF are conflicting. Thus, follow- up research is necessary.2

FDA is currently working with government, industry, and academic groups to ensure the proper follow-up to these industry-funded research findings. Collaboration with the Cellular Telecommunications Industry Association (CTIA) in particular is expected to lead to FDA providing research recommendations and scientific oversight of new CTIA-funded research based on such recommendations.

Two other studies of interest have been reported recently in the literature:

1.Two groups of 18 people were exposed to simulated mobile phone signals under laboratory conditions while they performed cognitive function test. There were no changes in the subjects’ ability to recall words, numbers, or pictures, or in their spatial memory, but they were able to make choices more quickly in one visual test when they were exposed to simulated mobile phone signals. This was

the only change noted among more than 20 variables compared.3

2.In study of 209 brain tumor cases and 425 matched controls, there was no increased risk of brain tumors associated with mobile phone use. When tumors did exist in certain locations, however, they were more likely to be on the side of the head where the mobile phone was used. Because this occurred in only a small number of cases, the

increased likelihood was too small to be statistically significant.4

In summary, we do not have enough information at this point to assure the public that there are, or are not, any low incident health problems associated with use of mobile phones. FDA continues to work with all parties, including other federal agencies and industry, to assure that research is undertaken to provide the necessary answers to the outstanding questions about the safety of mobile phones.

What is known about cases of human cancer that have been reported in users of handheld mobile phones?

Some people who have used mobile phones have been diagnosed with brain cancer. But it is important to understand that this type of cancer also occurs among people who have not used mobile phones. In fact, brain cancer occurs in the U.S. population at a rate of about 6 new cases per 100,000 people each year. At that rate, assuming 80 million users of mobile phones (a number increasing at a rate of about 1 million per month), about 4800 cases of brain cancer would be expected each year among those 80 million people, whether or not they used their phones. Thus it is not possible to tell whether any individual’s cancer arose because of the phone, or whether it would have happened anyway. A key question is whether the risk of getting a particular form of cancer is greater among people who use mobile phones than among the rest of the population. One way to answer that question is to compare the usage of mobile phones among people with brain cancer with the use of mobile phones among appropriately matched people without brain cancer. This is called a case-control study. The current case-control study of brain cancers by the National Cancer Institute, as well as the follow-up research to be sponsored by industry, will begin to generate this type of information.

What is FDA’s role concerning the safety of mobile phones?

Under the law, FDA does not review the safety of radiation-emitting consumer products such as mobile phones before marketing, as it does with new drugs or medical devices. However, the agency has authority to take action if mobile phones are shown to emit radiation at a level that is hazardous to the user. In such a case, FDA could require the manufacturers of mobile 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 at this time, FDA has urged the mobile phone industry to take a number of steps to assure public safety. The agency has recommended that the industry:

•support needed research into possible biological effects of RF of the type emitted by mobile phones;

•design mobile phones in a way that minimizes any RF exposure to the user that is not necessary for device function; and

98 Appendix C: Consumer Update