Nokia 2115i - Appendix B

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Appendix B Message from the FDA

(U.S. Food and Drug Administration)
to all users of mobile phones

©July 18, 2001For updates:

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.

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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.

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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. 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).

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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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Manufacturers of wireless phones must report the RF exposure level for each model
of phone to the FCC. The FCC website ( 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

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(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

Federal Communications Commission (FCC) RF Safety Program

International Commission on Non-Ionizing Radiation Protection

World Health Organization (WHO) International EMF Project

National Radiological Protection Board (UK)

July 18, 2001For updates:

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