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    							Health and Safety Information 116
    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 primary subject of the safety
    questions discussed in this document.
    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 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 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 dont 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. 
    						
    							117
    None of the studies demonstrated the existence of any harmful
    health effects from wireless phones 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 ten 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 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 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 
    						
    							Health and Safety Information 118
    research needs in the context of the latest research
    developments around the world.
    What steps can I take to reduce my exposure to radio 
    frequency 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 radio frequency
    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.
    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 radio frequency 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.
    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 
    						
    							119
    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 thatclaimed 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.
    What about wireless phone interference with 
    medical equipment?
    Radio frequency 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
    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 compatible hearing aid at the same time. This standard was
    approved by the IEEE in 2000. 
    						
    							Health and Safety Information 120
    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.
    Additional information on the safety of RF exposures from various
    sources can be obtained from the following organizations
    (Updated 1/1/2010):
    FCC RF Safety Program:http://www.fcc.gov/oet/rfsafety/
    Environmental Protection Agency (EPA):http://www.epa.gov/radiation/
    Occupational Safety and Health Administrations (OSHA):http://www.osha.gov/SLTC/radiofrequencyradiation/index.html
    National Institute for Occupational Safety and Health (NIOSH):http://www.cdc.gov/niosh/
    World Health Organization (WHO):http://www.who.int/peh-emf/
    International Commission on Non-Ionizing Radiation Protection:http://www.icnirp.de
    Health Protection Agency:http://www.hpa.org.uk/radiation
    US Food and Drug Administration:http://www.fda.gov/Radiation-EmittingProducts/
    RadiationEmittingProductsandProcedures/HomeBusinessandEntertainment/CellPhones/default.htm
    Road Safety
    Your wireless phone gives you the powerful ability to
    communicate by voice, almost anywhere, anytime. But an
    important responsibility accompanies the benefits of wireless
    phones, one that every user must uphold. Always comply with
    road safety regulations on using a mobile phone while driving.
    Using a mobile phone while driving can be dangerous.
    When driving a car, driving is your first responsibility. When using
    your wireless phone behind the wheel of a car, practice good
    common sense and remember the following tips:
    1.Get to know your wireless phone and its features, such as
    speed dial and redial. If available, these features help you
    to place your call without taking your attention off the road.
    2.When available, use a hands-free device. If possible, add
    an additional layer of convenience and safety to your
    wireless phone with one of the many hands free
    accessories available today. 
    						
    							1213.
    Position your wireless phone within easy reach. Be able to
    access your wireless phone without removing your eyes
    from the road. If you get an incoming call at an
    inconvenient time, let your voice mail answer it for you.
    4.Let the person you are speaking with know you are driving.
    Suspend the call in heavy traffic or hazardous weather
    conditions. Rain, sleet, snow, ice and even heavy traffic
    can be hazardous.
    5.Do not take notes or look up phone numbers while driving.
    Jotting down a “to do” list or flipping through your address
    book takes attention away from your primary
    responsibility, driving safely.
    6.Dial sensibly and assess the traffic; if possible, place calls
    when you are not moving or before pulling into traffic. Try
    to plan calls when your car will be stationary. If you need to
    make a call, dial only a few numbers, check the road and
    your mirrors, then continue.
    7.Do not engage in stressful or emotional conversations that
    may be distracting. Make people you are talking with
    aware you are driving and suspend conversations that
    have the potential to divert your attention from the road.
    8.Use your wireless phone to call for help. Dial 9-1-1 or other
    local emergency number in the case of fire, traffic accident
    or medical emergencies.
    9.Use your wireless phone to help others in emergencies. If
    you see an auto accident, crime in progress or other
    serious emergency where lives are in danger, call 9-1-1 or
    other local emergency number, as you would want others
    to do for you.
    10.Call roadside assistance or a special non-emergency
    wireless assistance number when necessary. If you see a
    broken-down vehicle posing no serious hazard, a broken
    traffic signal, a minor traffic accident where no one
    appears injured, or a vehicle you know to be stolen, call
    roadside assistance or other special non-emergency
    number. 
    						
    							Health and Safety Information 122
    “The wireless industry reminds you to use your phone safely when
    driving.”
    For more information, please call 1-888-901-SAFE, or visit our
    web-sitewww.ctia.org.
    Important!:If you are using a handset other than a standard numeric keypad,please call 1-888-901-7233.
    Provided by the Cellular Telecommunications & Internet
    Association.
    Responsible Listening
    Caution!:Avoid potential hearing loss.
    Damage to hearing occurs when a person is exposed to loud
    sounds over time. The risk of hearing loss increases as sound is
    played louder and for longer durations. Prolonged exposure to
    loud sounds (including music) is the most common cause of
    preventable hearing loss. Some scientific research suggests that
    using portable audio devices, such as portable music players and
    cellular telephones, at high volume settings for long durations
    may lead to permanent noise-induced hearing loss. This includes
    the use of headphones (including headsets, earbuds, and
    Bluetooth or other wireless devices). Exposure to very loud sound
    has also been associated in some studies with tinnitus (a ringing
    in the ear), hypersensitivity to sound and distorted hearing.Individual susceptibility to noise-induced hearing loss and
    potential hearing problem varies. Additionally, the amount of
    sound produced by a portable audio device varies depending on
    the nature of the sound, the device settings, and the headphones
    that are used. As a result, there is no single volume setting that is
    appropriate for everyone or for every combination of sound,
    settings and equipment.
    You should follow some commonsense recommendations when
    using any portable audio device:
    Always turn the volume down before plugging the earphones into an
    audio source.
    Set the volume in a quiet environment and select the lowest volume at
    which you can hear adequately.
    When using headphones, turn the volume down if you cannot hear the
    people speaking near you or if the person sitting next to you can hear
    what you are listening to.
    Do not turn the volume up to block out noisy surroundings. If you
    choose to listen to your portable device in a noisy environment, use
    noise-cancelling headphones to block out background environmental
    noise. By blocking background environment noise, noise cancelling
    headphones should allow you to hear the music at lower volumes than
    when using earbuds.
    Limit the amount of time you listen. As the volume increases, less time
    is required before you hearing could be affected. 
    						
    							123
    Avoid using headphones after exposure to extremely loud noises, such
    as rock concerts, that might cause temporary hearing loss. Temporary
    hearing loss might cause unsafe volumes to sound normal.
    Do not listen at any volume that causes you discomfort. If you
    experience ringing in your ears, hear muffled speech or experience
    any temporary hearing difficulty after listening to your portable audio
    device, discontinue use and consult your doctor.
    You can obtain additional information on this subject from the
    following sources:
    American Academy of Audiology
    11730 Plaza American Drive, Suite 300
    Reston, VA 20190
    Voice: (800) 222-2336
    Email: [email protected]
    Internet:
    http://www.audiology.orgNational Institute on Deafness and Other Communication Disorders
    National Institutes of Health
    31 Center Drive, MSC 2320
    Bethesda, MD 20892-2320
    Email: [email protected]
    Internet:
    http://www.nidcd.nih.gov/
    National Institute for Occupational Safety and Health (NIOSH)
    395 E Street, S.W.
    Suite 9200
    Patriots Plaza Building
    Washington, DC 20201
    Voice: 1-800-35-NIOSH (1-800-356-4647)
    1-800-CDC-INFO (1-800-232-4636)
    Outside the U.S. 513-533-8328
    Email: [email protected]
    Internet:
    http://www.cdc.gov/niosh/topics/noise/default.html
    1-888-232-6348 TTY 
    						
    							Health and Safety Information 124
    Operating Environment
    Remember to follow any special regulations in force in any area
    and always switch your phone off whenever it is forbidden to use
    it, or when it may cause interference or danger.
    When connecting the phone or any accessory to another device,
    read its users guide for detailed safety instructions. Do not
    connect incompatible products.
    As with other mobile radio transmitting equipment, users are
    advised that for the satisfactory operation of the equipment and
    for the safety of personnel, it is recommended that the
    equipment should only be used in the normal operating position
    (held to your ear with the antenna pointing over your shoulder if
    you are using an external antenna).
    Using Your Phone Near Other Electronic Devices
    Most modern electronic equipment is shielded from radio
    frequency (RF) signals. However, certain electronic equipment
    may not be shielded against the RF signals from your wireless
    phone. Consult the manufacturer to discuss alternatives.
    Implantable Medical Devices
    A minimum separation of six (6) inches should be maintained
    between a handheld wireless phone and an implantable medical
    device, such as a pacemaker or implantable cardioverter
    defibrillator, to avoid potential interference with the device.Persons
    who have such devices:
    Should ALWAYS keep the phone more than six (6) inches from their
    implantable medical device when the phone is turned ON;
    Should not carry the phone in a breast pocket;
    Should use the ear opposite the implantable medical device to
    minimize the potential for interference;
    Should turn the phone OFF immediately if there is any reason to
    suspect that interference is taking place;
    Should read and follow the directions from the manufacturer of your
    implantable medical device. If you have any questions about using
    your wireless phone with such a device, consult your health care
    provider.
    For more information see:
    http://www.fcc.gov/oet/rfsafety/rf-faqs.html
    FCC Hearing-Aid Compatibility (HAC) 
    Regulations for Wireless Devices
    On July 10, 2003, the U.S. Federal Communications Commission
    (FCC) Report and Order in WT Docket 01-309 modified the
    exception of wireless phones under the Hearing Aid Compatibility
    Act of 1988 (HAC Act) to require digital wireless phones be
    compatible with hearing-aids. 
    						
    							125
    The intent of the HAC Act is to ensure reasonable access to
    telecommunications services for persons with hearing
    disabilities.
    While some wireless phones are used near some hearing devices
    (hearing aids and cochlear implants), users may detect a
    buzzing, humming, or whining noise. Some hearing devices are
    more immune than others to this interference noise, and phones
    also vary in the amount of interference they generate.
    The wireless telephone industry has developed a rating system
    for wireless phones, to assist hearing device users find phones
    that may be compatible with their hearing devices. Not all phones
    have been rated. Phones that are rated have the rating on their
    box or a label located on the box.
    The ratings are not guarantees. Results will vary depending on
    the users hearing device and hearing loss. If your hearing device
    happens to be vulnerable to interference, you may not be able to
    use a rated phone successfully. Trying out the phone with your
    hearing device is the best way to evaluate it for your personal
    needs.
    M-Ratings: Phones rated M3 or M4 meet FCC requirements and
    are likely to generate less interference to hearing devices than
    phones that are not labeled. M4 is the better/higher of the two
    ratings.
    T-Ratings: Phones rated T3 or T4 meet FCC requirements and are
    likely to generate less interference to hearing devices than
    phones that are not labeled. T4 is the better/higher of the two
    ratings.
    Hearing devices may also be rated. Your hearing device
    manufacturer or hearing health professional may help you find
    this rating. Higher ratings mean that the hearing device is
    relatively immune to interference noise. The hearing aid and
    wireless phone rating values are then added together.
    A sum of 5 is considered acceptable for normal use. A sum of 6
    is considered for best use.
    In the above example, if a hearing aid meets the M2 level rating
    and the wireless phone meets the M3 level rating, the sum of the
    two values equal M5. This is synonymous for T ratings. This
    should provide the hearing aid user with “normal usage” while
    M3                 +                    M2         =     5T3                 +                    T2         =     5 
    						
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