Nokia 1221 - 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.

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.

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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 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.

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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.
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.

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