Appendix B Message from the FDA

Appendix B Message from the FDA
(U.S. Food and Drug Administration)
to all users of mobile phones.

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

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 radio frequency 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.

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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.

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 radio frequency 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 radio frequency energy (RF) exposures characteristic
of wireless phones have yielded conflicting results that often cannot be repeated

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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.

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.

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

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

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