Fda consumer update, Ch 10 – UTStarcom PN-820 User Manual

Page 273

background image





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 stand-by 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


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;


• 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 networks 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 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.

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. 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.