Nokia 6016i - Consumer Information on Wireless Phones

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How is radiofrequency radiation measured?

RF waves and RF fields have both electrical and magnetic components. It is
often convenient to express the strength of the RF field in terms of each
component. For example, the unit “volts per meter” (V/m) is used to measure
the electric field strength, and the unit “amperes per meter” (A/m) is used to
express the magnetic field strength. Another common way to characterize an
RF field is by means of the power density. Power density is defined as power
per unit area. For example, power density can be expressed in terms of
milliwatts (one thousandth of a watt) per square centimeter (mW/cm2 or
microwatts (one millionth of a watt) per square centimeter (µW/cm2).

The quantity used to measure how much RF energy is actually absorbed by the
body is called the Specific Absorption Rate or SAR. The SAR is a measure of the
rate of absorption of RF energy. It is usually expressed in units of watts per
kilogram (W/kg) or milliwatts per gram (mW/g).

What biological effects can be caused by RF energy?

The biological effects of radiofrequency energy should not be confused with
the effects from other types of electromagnetic energy.

Very high levels of electromagnetic energy, such as is found in X-rays and
gamma rays can ionize biological tissues. Ionization is a process where
electrons are stripped away from their normal locations in atoms and
molecules. It can permanently damage biological tissues including DNA, the
genetic material. Ionization only occurs with very high levels of
electromagnetic energy such as X-rays and gamma rays. Often the term
radiation is used when discussing ionizing radiation (such as that associated
with nuclear power plants).

The energy levels associated with radiofrequency energy, including both radio
waves and microwaves, are not great enough to cause the ionization of atoms
and molecules. Therefore, RF energy is a type of non-ionizing radiation. Other
types of non-ionizing radiation include visible light, infrared radiation (heat)
and other forms of electromagnetic radiation with relatively low frequencies.

Large amounts of RF energy can heat tissue. This can damage tissues and
increase body temperatures. Two areas of the body, the eyes and the testes, are
particularly vulnerable to RF heating because there is relatively little blood flow
in them to carry away excess heat.

The amount of RF radiation routinely encountered by the general public is too
low to produce significant heating or increased body temperature. Still, some
people have questions about the possible health effects of low levels of RF
energy. It is generally agreed that further research is needed to determine what
effects actually occur and whether they are dangerous to people. In the
meantime, standards-setting organizations and government agencies are
continuing to monitor the latest scientific findings to determine whether
changes in safety limits are needed to protect human health.

FDA, EPA and other US government agencies responsible for public health and
safety have worked together and in connection with WHO to monitor
developments and identify research needs related to RF biological effects.

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What levels of RF energy are considered safe?

Various organizations and countries have developed standards for exposure to
radiofrequency energy. These standards recommend safe levels of exposure for
both the general public and for workers. In the United States, the FCC has used
safety guidelines for RF environmental exposure since 1985.

The FCC guidelines for human exposure to RF electromagnetic fields are
derived from the recommendations of two expert organizations, the National
Council on Radiation Protection and Measurements (NCRP) and the Institute of
Electrical and Electronics Engineers (IEEE). In both cases, the
recommendations were developed by scientific and engineering experts drawn
from industry, government, and academia after extensive reviews of the
scientific literature related to the biological effects of RF energy.

Many countries in Europe and elsewhere use exposure guidelines developed by
the International Commission on Non-Ionizing Radiation Protection (ICNIRP).
The ICNIRP safety limits are generally similar to those of the NCRP and IEEE,
with a few exceptions. For example, ICNIRP recommends different exposure
levels in the lower and upper frequency ranges and for localized exposure from
certain products such as hand-held wireless telephones. Currently, the World
Health Organization is working to provide a framework for international
harmonization of RF safety standards.

The NCRP, IEEE, and ICNIRP all have identified a whole-body Specific
Absorption Rate (SAR) value of 4 watts per kilogram (4 W/kg) as a threshold
level of exposure at which harmful biological effects may occur. Exposure
guidelines in terms of field strength, power density and localized SAR were
then derived from this threshold value. In addition, the NCRP, IEEE, and ICNIRP
guidelines vary depending on the frequency of the RF exposure. This is due to
the finding that whole-body human absorption of RF energy varies with the
frequency of the RF signal. The most restrictive limits on whole-body exposure
are in the frequency range of 30-300 MHz where the human body absorbs RF
energy most efficiently. For products that only expose part of the body, such as
wireless phones, exposure limits in terms of SAR only are specified.

The exposure limits used by the FCC are expressed in terms of SAR, electric
and magnetic field strength, and power density for transmitters operating at
frequencies from 300 kHz to 100 GHz. The specific values can be found in two
FCC bulletins, OET Bulletins 56 and 65: http://www.fcc.gov/oet/info/documents/
bulletins/#56; http://www.fcc.gov/oet/info/documents/bulletins/#65.

Why has the FCC adopted guidelines for RF exposure?

The FCC authorizes and licenses products, transmitters, and facilities that
generate RF and microwave radiation. It has jurisdiction over all transmitting
services in the U.S. except those specifically operated by the Federal
Government. While the FCC does not have the expertise to determine radiation
exposure guidelines on its own, it does have the expertise and authority to
recognize and adopt technically sound standards promulgated by other expert
agencies and organizations, and has done so. (Our joint efforts with the FDA in
developing this website is illustrative of the kind of inter-agency efforts and
consultation we engage in regarding this health and safety issue.)

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Under the National Environmental Policy Act of 1969 (NEPA), the FCC has
certain responsibilities to consider whether its actions will significantly affect
the quality of the human environment. Therefore, FCC approval and licensing
of transmitters and facilities must be evaluated for significant impact on the
environment. Human exposure to RF radiation emitted by FCC-regulated
transmitters is one of several factors that must be considered in such
environmental evaluations. In 1996, the FCC revised its guidelines for RF
exposure as a result of a multi-year proceeding and as required by the
Telecommunications Act of 1996.

Radio and television broadcast stations, satellite-earth stations, experimental
radio stations and certain wireless communication facilities are required to
undergo routine evaluation for RF compliance when they submit an

application to the FCC for construction or modification of a transmitting facility
or renewal of a license. Failure to comply with the FCC's RF exposure
guidelines could lead to the preparation of a formal Environmental Assessment,
possible Environmental Impact Statement and eventual rejection of an
application. Technical guidelines for evaluating compliance with the FCC

RF safety requirements can be found in the FCC's OET Bulletin 65.

http://www.fcc.gov/oet/info/documents/bulletins/#65.

Low-powered, intermittent, or inaccessible RF transmitters and facilities are
normally excluded from the requirement for routine evaluation for RF
exposure. These exclusions are based on standard calculations and
measurement data indicating that a transmitting station or equipment operating
under the conditions prescribed is unlikely to cause exposures in excess of the
guidelines under normal conditions of use. Such exclusions are not exclusions
from compliance, but, rather, exclusions from routine evaluation. The FCC's
policies on RF exposure and categorical exclusion can be found in Section
1.1307(b) of the FCC's Rules and Regulations [(47 CFR 1.1307(b)].

How can I obtain the Specific Absorption Rate (SAR) value for my
wireless phone?

The FCC requires that wireless phones sold in the United States demonstrate
compliance with human exposure limits adopted by the FCC in 1996. The
relative amount of RF energy absorbed in the head of a wireless telephone-user
is given by the Specific Absorption Rate (SAR), as explained above. The FCC
requires wireless phones to comply with a safety limit of 1.6 watts per kilogram
(1.6 W/kg) in terms of SAR.

Information on SAR for a specific phone model can be obtained for many
recently manufactured phones using the FCC identification (ID) number for
that model. The FCC ID number is usually printed somewhere on the case of
the phone. Sometimes it may be necessary to remove the battery pack to find
the number. Once you have the ID number, go to the following Web address:
www.fcc.gov/oet/fccid. On this page, you will see instructions for entering the
FCC ID number. Type the FCC ID number exactly as requested (the Grantee
Code is the first three characters, the Equipment Product Code is the rest of the
FCC ID number). Then click on “Start Search.” The “Grant of Equipment
Authorization” for your telephone should appear. Read through the grant for
the section on “SAR Compliance,” “Certification of Compliance with FCC Rules

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for RF Exposure” or similar language. This section should contain the value(s)
for typical or maximum SAR for your phone.

Phones and other products authorized since June 2, 2000, should have the
maximum SAR levels noted directly on the “Grant of Equipment Authorization.”
For phones and products authorized between about mid-1998 and June 2000,
detailed information on SAR levels is typically found in the exhibits associated
with the grant. Once a grant is accessed, the exhibits can be viewed by clicking
on “View Exhibit.” Grants authorized prior to 1998 are not part of the electronic
database but, rather, have been documented in the form of paper records.

The FCC database does not list phones by model number. However, consumers
may find SAR information from other sources as well. Some wireless phone
manufacturers make SAR information available on their own Web sites. In addition,
some non-government Web sites provide SARs for specific models of wireless
phones. However, the FCC has not reviewed these sites and makes no guarantees
of their accuracy. Finally, phones certified by the Cellular Telecommunications and
Internet Association (CTIA) are required to provide SAR information to consumers
in the instructional materials that come with the phones.

Do hands-free kits for wireless phones reduce risks from exposure to

RF emissions?

Since there are no known risks from exposure to RF emissions from wireless
phones, there is no reason to believe that hands-free kits reduce risks. Hands-
free kits can be used with wireless phones for convenience and comfort. These
systems reduce the absorption of RF energy in the head because the phone,
which is the source of the RF emissions, will not be placed against the head.
On the other hand, if the phone is mounted against the waist or other part of
the body during use, then that part of the body will absorb more RF energy.
Wireless phones marketed in the U.S. are required to meet safety requirements
regardless of whether they are used against the head or against the body. Either
configuration should result in compliance with the safety limit.

Do wireless phone accessories that claim to shield the head from

RF radiation work?

Since there are no known risks from exposure to RF emissions from wireless
phones, there is no reason to believe that accessories that claim to shield the
head from those emissions reduce risks. Some products that claim to shield the
user from RF absorption use special phone cases, while others involve nothing
more than a metallic accessory attached to the phone. Studies have shown that
these products generally do not work as advertised. Unlike “hand-free” kits,
these so-called “shields” may interfere with proper operation of the phone. The
phone may be forced to boost its power to compensate, leading to an increase
in RF absorption. In February 2002, the Federal trade Commission (FTC)
charged two companies that sold devices that claimed to protect wireless
phone users from radiation with making false and unsubstantiated claims.
According to FTC, these defendants lacked a reasonable basis to substantiate
their claim.

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What are wireless telephone base stations?

Fixed antennas used for wireless telecommunications are referred to as cellular
base stations, cell stations, PCS (“Personal Communications Service”) stations
or telephone transmission towers. These base stations consist of antennas and
electronic equipment. Because the antennas need to be high in the air, they are
often located on towers, poles, water tanks, or rooftops. Typical heights for
freestanding base station towers are 50-200 feet.

Some base stations use antennas that look like poles, 10 to 15 feet in length, that
are referred to as “omni-directional” antennas. These types of antennas are usually
found in rural areas. In urban and suburban areas, wireless providers now more
commonly use panel or sector antennas for their base stations. These antennas
consist of rectangular panels, about 1 by 4 feet in dimension. The antennas are
usually arranged in three groups of three antennas each. One antenna in each
group is used to transmit signals to wireless phones, and the other two antennas in
each group are used to receive signals from wireless phones.

At any base station site, the amount of RF energy produced depends on the
number of radio channels (transmitters) per antenna and the power of each
transmitter. Typically, 21 channels per antenna sector are available. For a typical
cell site using sector antennas, each of the three transmitting antennas could be
connected to up to 21 transmitters for a total of 63 transmitters. However, it is
unlikely that all of the transmitters would be transmitting at the same time.
When omni-directional antennas are used, a cellular base station could
theoretically use up to 96 transmitters, but this would be very unusual, and,
once again, it is unlikely that all transmitters would be in operation
simultaneously. Base stations used for PCS communications generally require
fewer transmitters than those used for cellular radio transmissions, since PCS
carriers usually have a higher density of base station antenna sites.

Are wireless telephone base stations safe?

The electromagnetic RF signals transmitted from base station antennas stations
travel toward the horizon in relatively narrow paths. For example, the radiation
pattern for an antenna array mounted on a tower can be likened to a thin
pancake centered around the antenna system. The individual pattern for a
single array of sector antennas is wedge-shaped, like a piece of pie. As with all
forms of electromagnetic energy, the power decreases rapidly as one moves
away from the antenna. Therefore, RF exposure on the ground is much less
than exposure very close to the antenna and in the path of the transmitted
radio signal. In fact, ground-level exposure from such antennas is typically
thousands of times less than the exposure levels recommended as safe by
expert organizations. So exposure to nearby residents would be well within
safety margins.

Cellular and PCS base stations in the United States are required to comply with
limits for exposure recommended by expert organizations and endorsed by
government agencies responsible for health and safety. Measurements made
near cellular and PCS base station antennas mounted on towers have confirmed
that ground-level exposures are typically thousands of times less than the
exposure limits adopted by the FCC. In fact, in order to be exposed to levels at
or near the FCC limits for cellular or PCS frequencies an individual would

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essentially have to remain in the main transmitted radio signal (at the height of
the antenna) and within a few feet from the antenna. This is, of course, very
unlikely to occur.

When cellular and PCS antennas are mounted on rooftops, RF levels on that roof
or on others near by would probably be greater than those typically encountered
on the ground. However, exposure levels approaching or exceeding safety
guidelines should be encountered only very close to or directly in front of the
antennas. In addition, for sector-type antennas, typically used for such rooftop
base stations, RF levels to the side and in back of these antennas are insignificant.
General guidelines on antenna installations and circumstances that might give
rise to a concern about an facility's conformance with FCC regulations can be
found in A Local Government Official's Guide to Transmitting Antenna RF
Emission Safety: Rules, Procedures, and Practical Guidance. This Guide can be
accessed at: http://www.fcc.gov/oet/rfsafety.

Who regulates exposure to radiation from microwave ovens, television
sets and computer monitors?

The Food and Drug Administration is responsible for protecting the public
from harmful radiation emissions from these consumer products.

Does the FCC routinely monitor radiofrequency radiation from antennas?

The FCC does not have the resources or the personnel to routinely monitor the
emissions for all the thousands of transmitters that are subject to FCC
jurisdiction. However, the FCC does have measurement instrumentation for
evaluating RF levels in areas that may be accessible to the public or to workers.
If there is evidence for potential non-compliance with FCC exposure guidelines
for a FCC-regulated facility, staff from the FCC's Office of Engineering and
Technology or the FCC Enforcement Bureau can conduct and investigation,
and, if appropriate, perform actual measurements. Circumstances that could
give rise to a concern about an facility's conformance with FCC regulations can
be found in A Local Government Official's Guide to Transmitting Antenna RF
Emission Safety: Rules, Procedures, and Practical Guidance. This Guide can be
accessed at: http://www.fcc.gov/oet/rfsafety. Potential exposure problems should
be brought to the FCC's attention by contacting the FCC RF Safety Program at:
202-418-2464 or by email: rfsafety@fcc.gov.

Does the FCC maintain a database that includes information on the location
and technical parameters of all the transmitting towers it regulates?

Each of the FCC Bureaus maintains its own licensing database system for the
service(s) it regulates (e.g., television, cellular service, satellite earth stations.)
The FCC issues two types of licenses: site specific and market based. In the
case of site specific licensed facilities, technical operating information is
collected from the licensee as part of the licensing process. However, in the
case of market based licensing (e.g., PCS, cellular), the licensee is granted the
authority to operate a radio communications system in a geographic area using
as many facilities as are required, and the licensee is not required to provide the
FCC with specific location and operating parameters of these facilities.

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Information on site specific licensed facilities can be found the “General Menu
Reports” (GenMen) at http://gullfoss2.fcc.gov/cgi-bin/ws.exe/genmen/index.hts.

The various FCC Bureaus also publish on at least a weekly basis, bulk extracts
of their licensing databases. Each licensing database has its own unique file
structure. These extracts consist of multiple, very large files. The FCC's Office
of Engineering and Technology (OET) maintains an index to these databases at
http://www.fcc.gov/oet/info/database/fadb.html. Entry points into the various
databases include frequency, state/county, latitude/longitude, call-sign and
licensee name. For further information on the Commission's existing databases,
you can contact Donald Campbell at dcampbel@fcc.gov or 202-418-2405.

Can local and state governmental bodies establish limits for
RF exposure?

Although some local and state governments have enacted rules and regulations
about human exposure to RF energy in the past, the Telecommunications Act
of 1996 requires the Federal Government to control human exposure to RF
emissions. In particular, Section 704 of the Act states that, “No State or local
government or instrumentality thereof may regulate the placement,
construction, and modification of personal wireless service facilities on the
basis of the environmental effects of radio frequency emissions to the extent
that such facilities comply with the Commission's regulations concerning such
emissions.” Further information on federal authority and FCC policy is available
in a fact sheet from the FCC's Wireless Telecommunications Bureau at
www.fcc.gov/wtb.

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.

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:

䡲

Support needed research into possible biological effects of RF of the
type emitted by wireless phones;

䡲

Design wireless phones in a way that minimizes any RF exposure to the
user that is not necessary for device function; and

䡲

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:

䡲

National Institute for Occupational Safety and Health

䡲

Environmental Protection Agency

䡲

Federal Communications Commission

䡲

Occupational Safety and Health Administration

䡲

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 primary subject of the safety questions
discussed in this document.

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 well within the FCC's compliance limits.

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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.

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.

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.

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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.

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.

䡲

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.

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.

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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
that no interference occurs when a person uses a “compatible” phone and a
“compatible” 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.

Which other federal agencies have responsibilities related to potential
RF health effects?

Certain agencies in the Federal Government have been involved in monitoring,
researching or regulating issues related to human exposure to RF radiation.
These agencies include the Food and Drug Administration (FDA), the
Environmental Protection Agency (EPA), the Occupational Safety and Health
Administration (OSHA), the National Institute for Occupational Safety and
Health (NIOSH), the National Telecommunications and Information
Administration (NTIA) and the Department of Defense (DOD).

By authority of the Radiation Control for Health and Safety Act of 1968, the
Center for Devices and Radiological Health (CDRH) of the FDA develops
performance standards for the emission of radiation from electronic products
including X-ray equipment, other medical devices, television sets, microwave
ovens, laser products and sunlamps. The CDRH established a product
performance standard for microwave ovens in 1971 limiting the amount of RF
leakage from ovens. However, the CDRH has not adopted performance
standards for other RF-emitting products. The FDA is, however, the lead federal
health agency in monitoring the latest research developments and advising
other agencies with respect to the safety of RF-emitting products used by the
public, such as cellular and PCS phones.

The FDA's microwave oven standard is an emission standard (as opposed to an
exposure standard) that allows specific levels of microwave leakage (measured at
five centimeters from the oven surface). The standard also requires ovens to have
two independent interlock systems that prevent the oven from generating
microwaves the moment that the latch is released or the door of the oven is

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opened. The FDA has stated that ovens that meet its standards and are used
according to the manufacturer's recommendations are safe for consumer and
industrial use. More information is available from: www.fda.gov/cdrh.

The EPA has, in the past, considered developing federal guidelines for public
exposure to RF radiation. However, EPA activities related to RF safety and
health are presently limited to advisory functions. For example, the EPA now
chairs an Inter-agency Radiofrequency Working Group, which coordinates RF
health-related activities among the various federal agencies with health or
regulatory responsibilities in this area.

OSHA is responsible for protecting workers from exposure to hazardous
chemical and physical agents. In 1971, OSHA issued a protection guide for
exposure of workers to RF radiation [29 CFR 1910.97]. However, this guide
was later ruled to be only advisory and not mandatory. Moreover, it was based
on an earlier RF exposure standard that has now been revised. At the present
time, OSHA uses the IEEE and/or FCC exposure guidelines for enforcement
purposes under OSHA's “general duty clause” (for more information see:

http://www.osha-slc.gov/SLTC/radiofrequencyradiation/index.html.

NIOSH is part of the U.S. Department of Health and Human Services. It
conducts research and investigations into issues related to occupational
exposure to chemical and physical agents. NIOSH has, in the past, undertaken
to develop RF exposure guidelines for workers, but final guidelines were never
adopted by the agency. NIOSH conducts safety-related RF studies through its
Physical Agents Effects Branch in Cincinnati, Ohio.

The NTIA is an agency of the U.S. Department of Commerce and is responsible
for authorizing Federal Government use of the RF electromagnetic spectrum.
Like the FCC, the NTIA also has NEPA responsibilities and has considered
adopting guidelines for evaluating RF exposure from U.S. Government
transmitters such as radar and military facilities.

The Department of Defense (DOD) has conducted research on the biological
effects of RF energy for a number of years. This research is now conducted
primarily at the U.S. Air Force Research Laboratory located at Brooks Air Force
Base, Texas. The DOD Web site for RF biological effects information is listed
with other sites in conjunction with a question on other sources of
information, below.

Who funds and carries out research on the biological effects of

RF energy?

Research into possible biological effects of RF energy is carried out in
laboratories in the United States and around the world. In the U.S., most
research has been funded by the Department of Defense, due to the extensive
military use of RF equipment such as radar and high-powered radio
transmitters. In addition, some federal agencies responsible for health and
safety, such as the Environmental Protection Agency (EPA) and the U.S. Food
and Drug Administration (FDA), have sponsored and conducted research in this
area. At the present time, most of the non-military research on biological
effects of RF energy in the U.S. is being funded by industry organizations. More
research is being carried out overseas, particularly in Europe.

Section 4A: Safety Guidelines

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In 1996, the World Health Organization (WHO) established the International
EMF Project to review the scientific literature and work towards resolution of
health concerns over the use of RF technology. WHO maintains a Web site that
provides extensive information on this project and about RF biological effects
and research (www.who.ch/peh-emf).

FDA, EPA and other US government agencies responsible for public health and
safety have worked together and in connection with WHO to monitor
developments and identify research needs related to RF biological effects.

How does FCC Audit Cell Phone RF?

After FCC grants permission for a particular cellular telephone to be marketed,
FCC will occasionally conduct “post-grant” testing to determine whether
production versions of the phone are being produced to conform with FCC
regulatory requirements. The manufacturer of a cell phone that does not meet
FCC's regulatory requirements may be required to remove the cell phone from
use and to refund the purchase price or provide a replacement phone, and may
be subject to civil or criminal penalties. In addition, if the cell phone presents a
risk of injury to the user, FDA may also take regulatory action. The most
important post-grant test, from a consumer's perspective, is testing of the RF
emissions of the phone. FCC measures the Specific Absorption Rate (SAR) of
the phone, following a very rigorous testing protocol. As is true for nearly any
scientific measurement, there is a possibility that the test measurement may be
less than or greater than the actual RF emitted by the phone. This difference
between the RF test measurement and actual RF emission is because test
measurements are limited by instrument accuracy, because test measurement
and actual use environments are different, and other variable factors. This
inherent variability is known as “measurement uncertainty.” When FCC
conducts post-grant testing of a cell phone, FCC takes into account any
measurement uncertainty to when determining whether regulatory action is
appropriate. This approach ensures that when FCC takes regulatory action, it
will have a sound, defensible scientific basis.

FDA scientific staff reviewed the methodology used by FCC to measure cell
phone RF, and agreed it is an acceptable approach, given our current
understanding of the risks presented by cellular phone RF emissions. RF
emissions from cellular phones have not been shown to present a risk of injury
to the user when the measured SAR is less than the safety limits set by FCC (an
SAR of 1.6 w/kg). Even in a case where the maximum measurement
uncertainty permitted by current measurement standards was added to the
maximum permissible SAR, the resulting SAR value would be well below any
level known to produce an acute effect. Consequently, FCC's approach with
measurement uncertainty will not result in consumers being exposed to any
known risk from the RF emitted by cellular telephones.

FDA will continue to monitor studies and literature reports concerning acute
effects of cell phone RF, and concerning chronic effects of long-term exposure
to cellular telephone RF (that is, the risks from using a cell phone for many
years). If new information leads FDA to believe that a change to FCC's
measurement policy may be appropriate, FDA will contact FCC and both
agencies will work together to develop a mutually-acceptable approach.