Helio Ocean user manual What are the results of the research done already?

SAFETY AND WARRANTY FDA CONSUMER UPDATE

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 radiofrequency energy (RF) exposures characteristic of wireless handsets 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 handsets, so we don’t know with certainty what the results of such studies mean for human health. Three large epidemiology stud- ies have been published since December 2000. Between them, the studies investigated any possible association between the use of wireless hand- sets 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 handset RF exposures. However, none of the studies can answer questions about long-term exposures, since the average peri- od of handset use in these studies was around three years.

5. What research is needed to decide whether RF exposure from wireless handsets poses a health risk?

A combination of laboratory studies and epidemiological studies of people actually using wireless handsets 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 handsets. Many factors affect this measurement, such as the angle at which the handset is held, or which model of handset is used.

FDA CONSUMER UPDATE SAFETY AND WARRANTY

6.What is FDA doing to find out more about the possible health effects of wireless handset 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 handset 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 handset 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 handset?

All handsets 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 devices 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 handset and is set well below levels known to have effects. Manufacturers of wireless handsets must report the RF exposure level for each model of handset to the FCC. The FCC website (http://www.fcc.gov/oet/rfsafety) gives directions for locating the FCC identification number on your handset so you can find your hand- set’s RF exposure level in the online listing.

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