Safety Guide

Safety Guidelines
Important information
about hearing aid
compatibility
FCC Statement
Safety Guidelines
Before a device model is available for sale to the public, it
must be tested and certified to the FCC that it does not
exceed the limit established by the government-adopted
requirement for safe exposure. The tests are performed in
positions and locations (i.e., at the ear and worn on the
body) as required by the FCC for each model. Body worn
measurements are made while the device is in use and
worn on the body with a Sony Mobile accessory.
The design and composition of an accessory can affect the
body worn Specific Absorption Rate (SAR) levels for the
device. Sony Mobile has not measured, and makes no
representation about, the body worn SAR levels when the
device is used with non-Sony Mobile accessories.
Consumer Update on Wireless Devices
Supplied by the U.S. Food and Drug
Administration (FDA) - Center for Devices
and Radiological Health
Do wireless devices pose a health hazard?
The available scientific evidence does not show that any
health problems are associated with using wireless devices.
There is no proof, however, that wireless devices are
absolutely safe. Wireless devices emit low levels of radio
frequency 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
devices?
Under the law, FDA does not review the safety of
radiation-emitting consumer products such as wireless
devices before they can be sold, as it does with new drugs
or medical devices. However, the agency has authority to
take action if wireless devices 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 devices to notify users of the health hazard and to
repair, replace or recall the devices so that the hazard no
longer exists.
Although the existing scientific data do not justify FDA
regulatory actions, FDA has urged the wireless device
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 devices;
• Design wireless devices 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 devices with the
best possible information on possible effects of wireless
device 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 devices
with the Federal Communications Commission (FCC).
All devices 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 devices.
FCC also regulates the base stations that the wireless device
networks rely upon. While these base stations operate at
higher power than do the wireless devices themselves, the
RF exposures that people get from these base stations are
typically thousands of times lower than those they can get
from wireless devices. Base stations are thus not the subject
of the safety questions discussed in this document.
What kinds of devices are the subject of this update?
The term wireless device refers here to hand-held wireless
devices with built-in antennas, often called “cell,” “mobile,”
or “PCS” devices. These types of wireless devices can expose
the user to measurable radio frequency energy (RF) because
of the short distance between the device 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 device 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 devices,” 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.
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 devices 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
devices, 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 devices 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 device RF exposures. However, none of
the studies can answer questions about long-term
exposures, since the average period of device use in these
studies was around three years.
What research is needed to decide whether RF
exposure from wireless devices poses a health risk?
A combination of laboratory studies and epidemiological
studies of people actually using wireless devices 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 devices. Many
factors affect this measurement, such as the angle at which
the device is held, or which model of device is used.
What is FDA doing to find out more about the
possible health effects of wireless device 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 radio
frequency 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 device 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 device users.
The CRADA will also include a broad assessment of
additional research needs in the context of the latest
research developments around the world.
How can I find out how much radio frequency
energy exposure I can get by using my wireless
device?
All devices sold in the United States must comply with
Federal Communications Commission (FCC) guidelines that
limit radio frequency 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 device and is
set well below levels known to have effects.
Manufacturers of wireless devices must report the RF
exposure level for each model of device to the FCC. The FCC
website (http://www.fcc.gov/oet/rfsafety) gives directions
for locating the FCC identification number on your device so
you can find your device’s RF exposure level in the online
listing.