Alcatel Mobile Phone User's Guide download pdf (Page 57)

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FDA CONSUMER UPDATE

U.S. FOOD AND DRUG ADMINISTRATION - CENTER FOR DEVICES AND

RADIOLOGICAL

HEALTH CONSUMER UPDATE ON WIRELESS PHONES

1. Do wireless phones pose a health hazard?

The available scientific evidence does not show that any health problems are associated with using wireless phones. There is no proof,

however, that wireless phones are absolutely safe. Wireless phones emit low levels of radiofrequency energy (RF) in the microwave range

while being used. They also emit very low levels of RF when in the idle mode. Whereas high levels of RF can produce health effects (by

heating tissue), exposure to low level RF that does not produce heating effects causes no known adverse health effects. Many studies of

low level RF exposures have not found any biological effects. Some studies have suggested that some biological effects may occur, but

such findings have not been confirmed by additional research. In some cases, other researchers have had difficulty in reproducing those

studies, or in determining the reasons for inconsistent results.

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 information 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 net works 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

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 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

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 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 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 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 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.

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 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.

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