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FDA CONSUMER UPDATE
FDA CONSUMER UPDATE
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 standby 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  radiationemitting  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 wire-
less  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. Although the existing scientific data
do not justify FDA regulatory actions, FDA has urged the wireless phone industry
to take a number of steps, including the following:
• Support needed research into possible biological effects of RF of the type 
emitted by wireless phones;
• Design wireless phones in a way that minimizes any RF exposure to the user 
that is not necessary for device function;
and
• Cooperate in providing users of wireless phones with the best possible 
information on possible effects of wireless phone use on human health. 
FDA  belongs  to  an  interagency  working  group  of  the  federal  agencies  that  have
responsibility for different aspects of RF safety to ensure coordinated efforts at the
federal level. The following agencies belong to this working group:
• National Institute for Occupational Safety and Health
• Environmental Protection Agency
• Federal Communications Commission
• Occupational Safety and Health Administration
• National Telecommunications and Information Administration
The National Institutes of Health participates in some inter-agency 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.
U.S. Food and Drug Administration -Center for Devices and
Radiological Health Consumer Update on Wireless Phones
These types of wireless phones can expose the user to measurable radiofrequency
energy (RF) because of the short distance between the phone and the user’s head.
These  RF  exposures  are  limited  by  Federal  Communications  Commission  safety
guidelines that were developed with the advice of FDA and other federal health and
safety agencies. When the phone is located at greater distances from the user, the
exposure  to  RF  is  drastically  lower  because  a  person’s  RF  exposure  decreases
rapidly with increasing distance from the source. The so-called “cordless phones,”
which  have  a  base  unit  connected  to  the  telephone  wiring  in  a  house,  typically
operate at far lower power levels, and thus produce RF exposures far below the
FCC safety limits. 
4. What are the results of the research done already?
The  research  done  thus  far  has  produced  conflicting  results,  and  many  studies
ha ve  suffe red  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 predisposed 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 neu-
roma, 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 expo-sure 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
epidemiologi-cal  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). 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 pro-
grams around the world.
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TX-95C-TNZ향1125  11/25/03 3:27 PM  페이지132