Nokia 6255i - Appendix B Message from the FDA

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Consumer Update on Wireless Phones

U.S. Food and Drug Administration

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 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 interagency working

group activities, as well.

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Appendix B Message from the FDA

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 pre-disposed 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

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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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Appendix B Message from the FDA

7. How can I find out how much radiofrequency energy exposure I can get by

using my wireless phone?

All phones sold in the United States must comply with Federal Communications

Commission (FCC) guidelines that limit radiofrequency energy (RF)

exposures. FCC established these guidelines in consultation with FDA and

the other federal health and safety agencies. The FCC limit for RF exposure

from wireless telephones is set at a Specific Absorption Rate (SAR) of 1.6

watts per kilogram (1.6 W/kg). The FCC limit is consistent with the safety

standards developed by the Institute of Electrical and Electronic Engineering

(IEEE) and the National Council on Radiation Protection and Measurement.

The exposure limit takes into consideration the body’s ability to remove heat

from the tissues that absorb energy from the wireless phone and is set well

below levels known to have effects.
Manufacturers of wireless phones must report the RF exposure level for each

model of phone to the FCC. The FCC website (http://www.fcc.gov/oet/rfsafety)

gives directions for locating the FCC identification number on your phone

so you can find your phone’s RF exposure level in the online listing.

8. What has FDA done to measure the radiofrequency energy coming from

wireless phones?

The Institute of Electrical and Electronic Engineers (IEEE) is developing a

technical standard for measuring the radiofrequency energy (RF) exposure

from wireless phones and other wireless handsets with the participation and

leadership of FDA scientists and engineers. The standard, Recommended

Practice for Determining the Spatial-Peak Specific Absorption Rate (SAR) in

the Human Body Due to Wireless Communications Devices: Experimental

Techniques, sets forth the first consistent test methodology for measuring

the rate at which RF is deposited in the heads of wireless phone users. The

test method uses a tissue-simulating model of the human head. Standardized

SAR test methodology is expected to greatly improve the consistency of

measurements made at different laboratories on the same phone. SAR is the

measurement of the amount of energy absorbed in tissue, either by the whole

body or a small part of the body. It is measured in watts/kg (or milliwatts/g)

of matter. This measurement is used to determine whether a wireless phone

complies with safety guidelines.

9. What steps can I take to reduce my exposure to radiofrequency energy

from my wireless phone?

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 you are concerned about avoiding

even potential risks, you can take a few simple steps to minimize your

exposure to radiofrequency energy (RF). Since time is a key factor in how

much exposure a person receives, reducing the amount of time spent using

a wireless phone will reduce RF exposure.

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If you must conduct extended conversations by wireless phone every day,

you could place more distance between your body and the source of the RF,

since the exposure level drops off dramatically with distance. For example,

you could use a headset and carry the wireless phone away from your body

or use a wireless phone connected to a remote antenna.
Again, the scientific data do not demonstrate that wireless phones are harmful.

But if you are concerned about the RF exposure from these products, you

can use measures like those described above to reduce your RF exposure

from wireless phone use.

10. What about children using wireless phones?

The scientific evidence does not show a danger to users of wireless phones,

including children and teenagers. If you want to take steps to lower exposure

to radiofrequency energy (RF), the measures described above would apply

to children and teenagers using wireless phones. Reducing the time of

wireless phone use and increasing the distance between the user and the RF

source will reduce RF exposure.Some groups sponsored by other national

governments have advised that children be discouraged from using wireless

phones at all. For example, the government in the United Kingdom distributed

leaflets containing such a recommendation in December 2000. They noted

that no evidence exists that using a wireless phone causes brain tumors or

other ill effects. Their recommendation to limit wireless phone use by

children was strictly precautionary; it was not based on scientific evidence

that any health hazard exists.

11. What about wireless phone interference with medical equipment?

Radiofrequency energy (RF) from wireless phones can interact with some

electronic devices. For this reason, FDA helped develop a detailed test method

to measure electromagnetic interference (EMI) of implanted cardiac

pacemakers and defibrillators from wireless telephones. This test method is

now part of a standard sponsored by the Association for the Advancement

of Medical instrumentation (AAMI). The final draft, a joint effort by FDA,

medical device manufacturers, and many other groups, was completed in

late 2000. This standard will allow manufacturers to ensure that cardiac

pacemakers and defibrillators are safe from wireless phone EMI. FDA has

tested hearing aids for interference from handheld wireless phones and

helped develop a voluntary standard sponsored by the Institute of Electrical

and Electronic Engineers (IEEE). This standard specifies test methods and

performance requirements for hearing aids and wireless phones so that no

interference occurs when a person uses a compatible phone and a accompanied

hearing aid at the same time. This standard was approved by the IEEE in 2000.
FDA continues to monitor the use of wireless phones for possible interactions

with other medical devices. Should harmful interference be found to occur, FDA

will conduct testing to assess the interference and work to resolve the problem.

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Appendix B Message from the FDA

12. Where can I find additional information?

For additional information, please refer to the following resources:
• FDA web page on wireless phones

http://www.fda.gov/cdrh/phones/index.html

• Federal Communications Commission (FCC) RF Safety Program

http://www.fcc.gov/oet/rfsafety

• International Commission on Non-Ionizing Radiation Protection

http://www.icnirp.de

• World Health Organization (WHO) International EMF Project

http://www.who.int/emf

• National Radiological Protection Board (UK)

http://www.nrpb.org.uk/

July 18, 2001 For updates: http://www.fda.gov/cdrh/phones

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NOTES