Nokia 1260 - 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 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 studiesas

around three years.

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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.

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.

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Appendix B Message from the FDA

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.
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

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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.

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