A p p e n d i c e s
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.
•What kinds of phones are the subject of this update? The term wireless phone refers here to
•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
•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
•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 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.
•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.
•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
•What steps can I take to reduce my exposure to radiofrequency energy from my wireless phone? If there is a risk from these
•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.
•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 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.
•Where can I find additional information? For additional information, please refer to the following resources:
FDA web page on wireless phoneshttp://www.fda.gov/cdrh/phones/index.html http://www.fda.gov/cdrh/phones/index.html Federal Communications Commission (FCC) RF Safety Program http://www.fda.gov/cdrh/phones/index.html
International Commission on
National Radiological Protection Board (UK) http://www.nrpb.org.uk/ 2004 For updates:http://www.fda.gov/cdrh/phones
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