26 October 1999
Source: http://www.usia.gov/cgi-bin/washfile/display.pl?p=/products/washfile/latest&f=99102501.glt&t=/products/washfile/newsitem.shtml

US Department of State
International Information Programs

Washington File

25 October 1999

Food & Drug Administration on Cell Phone Safety

 (Evidence on possible health risks inconclusive) (2540)

 Every year, the numbers of people using cellular telephones increases
 by the millions. The convenience of these devices is indisputable, but
 their safety remains inconclusive. The U.S. Food and Drug
 Administration (FDA) reports, "the available scientific evidence does
 not allow us to conclude that mobile phones are absolutely safe, or
 that they are unsafe."

 In "Consumer Update on Mobile Phones," the FDA summarizes the research
 on the health effects of the devices in a document issued on October
 20 entitled, "Consumer Update on Mobile Phones."

 The potential risk of a mobile phone comes from its emission of low
 levels of radiofrequency radiation (RF), the same type of energy that
 comes off a microwave oven. The RF pulses off the device's antenna
 right next to the user's head, and that proximity to the brain is what
 concerns some researchers.

 The FDA says the research in this field is conflicting, but points up
 two findings that merit further examination. One study showed an
 association between mobile phone use and one rare type of brain
 cancer, but the FDA report also underscores that the finding could
 have been chance. A second study suggests that cell phone radiation
 may have some effect on an individual's genetic material.

 None of the data warrant intervention by the FDA, the consumer update
 says, but the agency is pursuing further action. It is urging the
 mobile phone industry to conduct further research; design phones to
 minimize RF exposure to the user; and keep the public informed about
 health issues surrounding the use of these devices.

 Despite its cautions about the inconclusive nature of any findings
 about health risks, the FDA does offer some suggestions to cell-phone
 using consumers: don't hold prolonged conversations on the mobile
 phone; use a phone design that moves the antenna away from the head.

 Following is the text of the FDA's Consumer Update

 (begin text)

 October 20, 1999

 U.S. food and Drug Administration
 Center for Devices and Radiological Health

 Consumer Update on Mobile Phones

 FDA has been receiving inquiries about the safety of mobile phones,
 including cellular phones and PCS (personal communications system)
 phones. The following summarizes what is known--and what remains
 unknown--about whether these products can pose a hazard to health, and
 what can be done to minimize any potential risk. This information may
 be used to respond to questions.

 Why the concern?

 Mobile phones emit low levels of radiofrequency energy (i.e.,
 radiofrequency radiation) in the microwave range while being used.
 They also emit very low levels of radiofrequency energy (RF),
 considered non-significant, when in the stand-by mode. It is well
 known that high levels of RF can produce biological damage through
 heating effects (this is how your microwave oven is able to cook
 food). However, it is not known whether, to what extent, or through
 what mechanism, lower levels of RF might cause adverse health effects
 as well. Although some research has been done to address these
 questions, no clear picture of the biological effects of this type of
 radiation has emerged to date. Thus, the available science does not
 allow us to conclude that mobile phones are absolutely safe, or that
 they are unsafe. However, the available scientific evidence does not
 demonstrate any adverse health effects associated with the use of
 mobile phones.

 What kinds of phones are in question?

 Questions have been raised about hand-held mobile phones, the kind
 that have a built-in antenna that is positioned close to the user's
 head during normal telephone conversation. These types of mobile
 phones are of concern because of the short distance between the
 phone's antenna--the primary source of the RF--and the person's head.
 The exposure to RF from mobile phones in which the antenna is located
 at greater distances from the user (on the outside of a car, for
 example) is drastically lower than that from hand-held phones, because
 a person's RF exposure decreases rapidly with distance from the
 source. The safety of so-called "cordless phones," which have a base
 unit connected to the telephone wiring in a house and which operate at
 far lower power levels and frequencies, has not been questioned.

 How much evidence is there that hand-held mobile phones might be

 Briefly, there is not enough evidence to know for sure, either way;
 however, research efforts are on-going. The existing scientific
 evidence is conflicting and many of the studies that have been done to
 date have suffered from flaws in their research methods. Animal
 experiments investigating the effects of RF exposures characteristic
 of mobile phones have yielded conflicting results. A few animal
 studies, however, have suggested that low levels of RF could
 accelerate the development of cancer in laboratory animals. In one
 study, mice genetically altered to be predisposed to developing one
 type of cancer developed more than twice as many such cancers when
 they were exposed to RF energy compared to controls. There is much
 uncertainty among scientists about whether results obtained from
 animal studies apply to the use of mobile phones. First, it is
 uncertain how to apply the results obtained in rats and mice to
 humans. Second, many of the studies that showed increased tumor
 development used animals that had already been treated with
 cancer-causing chemicals, and other studies exposed the animals to the
 RF virtually continuously--up to 22 hours per day.

 For the past five years in the United States, the mobile phone
 industry has supported research into the safety of mobile phones. This
 research has resulted in two findings in particular that merit
 additional study:

 1. In a hospital-based, case-control study, researchers looked for an
 association between mobile phone use and either glioma (a type of
 brain cancer) or acoustic neuroma (a benign tumor of the nerve
 sheath). No statistically significant association was found between
 mobile phone use and acoustic neuroma. There was also no association
 between mobile phone use and gliomas when all types of types of
 gliomas were considered together. It should be noted that the average
 length of mobile phone exposure in this study was less than three

 When 20 types of glioma were considered separately, however, an
 association was found between mobile phone use and one rare type of
 glioma, neuroepithelliomatous tumors. It is possible with multiple
 comparisons of the same sample that this association occurred by
 chance. Moreover, the risk did not increase with how often the mobile
 phone was used, or the length of the calls. In fact, the risk actually
 decreased with cumulative hours of mobile phone use. Most cancer
 causing agents increase risk with increased exposure. An ongoing study
 of brain cancers by the National Cancer Institute is expected to bear
 on the accuracy and repeatability of these results.(1)

 2. Researchers conducted a large battery of laboratory tests to assess
 the effects 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 of 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

 1. Two groups of 18 people were exposed to simulated mobile phone
 signals under laboratory conditions while they performed cognitive
 function tests. 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 a 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 hand-held 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

 -- cooperate in providing mobile phone users with the best possible
 information on what is known about possible effects of mobile phone
 use on human health.

 At the same time, FDA belongs to an interagency working group of the
 federal agencies that have responsibility for different aspects of
 mobile phone safety to ensure a coordinated effort at the federal
 level. These agencies are:

 -- National Institute for Occupational Safety and Health
 -- Environmental Protection Agency
 -- Federal Communications Commission
 -- Occupational Health and Safety Administration
 -- National Telecommunications and Information Administration

 The National Institutes of Health also participates in this group.

 In the absence of conclusive information about any possible risk, what
 can concerned individuals do?

 If there is a risk from these products--and at this point we do not
 know that there is--it is probably very small. But if people are
 concerned about avoiding even potential risks, there are simple steps
 they can take to do so. For example, time is a key factor in how much
 exposure a person receives. Those persons who spend long periods of
 time on their hand-held mobile phones could consider holding lengthy
 conversations on conventional phones and reserving the hand-held
 models for shorter conversations or for situations when other types of
 phones are not available.

 People who must conduct extended conversations in their cars every day
 could switch to a type of mobile phone that places more distance
 between their bodies and the source of the RF, since the exposure
 level drops off dramatically with distance. For example, they could
 switch to

 -- a mobile phone in which the antenna is located outside the vehicle,

 -- a hand-held phone with a built-in antenna connected to a different
 antenna mounted on the outside of the car or built into a separate
 package, or

 -- a headset with a remote antenna to a mobile phone carried at the

 Again, the scientific data do not demonstrate that mobile phones are
 harmful. But if people are concerned about the radiofrequency energy
 from these products, taking the simple precautions outlined above can
 reduce any possible risk.

 Where can I find additional information?

 For additional information, see the following websites:

 -- Federal Communications Commission (FCC) RF Safety Program (select
 "Information on Human Exposure to RF Fields from Cellular and PCS
 Radio Transmitters"): http://www.fcc.gov/oet/rfsafety

 -- World Health Organization (WHO) International Commission on
 Non-Ionizing Radiation Protection (select Qs & As):

 -- United Kingdom, National Radiological Protection Board:

 1. Muscat et al. Epidemiological Study of Cellular Telephone Use and
 Malignant Brain Tumors. In: State of the Science Symposium;1999 June
 20; Long Beach, California.

 2. Tice et al. Tests of mobile phone signals for activity in
 genotoxicity and other laboratory assays. In: Annual Meeting of the
 Environmental Mutagen Society; March 29, 1999, Washington, D.C.; and
 personal communication, unpublished results.

 3. Preece, AW, Iwi, G, Davies-Smith, A, Wesnes, K, Butler, S, Lim, E,
 and Varey, A. Effect of a 915-MHz simulated mobile phone signal on
 cognitive function in man. Int. J. Radiat. Biol., April 8, 1999.

 4. Hardell, L, Nasman, A, Pahlson, A, Hallquist, A and Mild, KH. Use
 of cellular telephones and the risk for brain tumors: a case-control
 study. Int. J. Oncol., 15: 113-116, 1999.

 (end text)

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 Department of State)