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of a cell phone that does not meet FCC's regulatory requirements may be required to remove
the cell phone from use and to refund the purchase price or provide a replacement phone,
and may be subject to civil or criminal penalties. In addition, if the cell phone presents a risk
of injury to the user, FDA may also take regulatory action. The most important post-grant
test, from a consumer's perspective, is testing of the RF emissions of the phone. FCC
measures the Specific Absorption Rate (SAR) of the phone, following a very rigorous testing
protocol. As is true for nearly any scientific measurement, there is a possibility that the test
measurement may be less than or greater than the actual RF emitted by the phone. This
difference between the RF test measurement and actual RF emission is because test
measurements are limited by instrument accuracy, because test measurement and actual
use environments are different, and other variable factors. This inherent variability is known
as "measurement uncertainty." When FCC conducts post-grant testing of a cell phone, FCC
takes into account any measurement uncertainty to determine whether regulatory action is
appropriate. This approach ensures that when FCC takes regulatory action, it will have a
sound, defensible scientific basis.
FDA scientific staff reviewed the methodology used by FCC to measure cell phone RF, and
agreed it is an acceptable approach, given our current understanding of the risks presented
by cellular phone RF emissions. RF emissions from cellular phones have not been shown to
present a risk of injury to the user when the measured SAR is less than the safety limits set
by FCC (an SAR of 1.6 w/kg). Even in a case where the maximum measurement uncertainty
permitted by current measurement standards was added to the maximum permissible SAR,
the resulting SAR value would be well below any level known to produce an acute effect.
Consequently, FCC's approach with measurement uncertainty will not result in consumers
being exposed to any known risk from the RF emitted by cellular telephones.
FDA will continue to monitor studies and literature reports concerning acute effects of cell
phone RF, and concerning chronic effects of long-term exposure to cellular telephone RF
(that is, the risks from using a cell phone for many years). If new information leads FDA to
believe that a change to FCC's measurement policy may be appropriate, FDA will contact
FCC and both agencies will work together to develop a mutually-acceptable approach.
Updated July 29, 2003
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