Telecommunications: Research and Regulatory Efforts on Mobile	 
Phone Health Issues (07-MAY-01, GAO-01-545).			 
								 
The consensus of the Food and Drug Administration (FDA), the	 
World Health Organization, and other major health agencies is	 
that the research to date does not show radiofrequency energy	 
emitted from mobile phones has harmful health effects, but there 
is not yet enough information to conclude that they pose no risk.
Although most of the epidemiological and laboratory studies done 
on this issue have found no adverse health effects, the findings 
of some studies have raised questions about cancer and other	 
health problems that require further study. The Cellular	 
Telecommunication & Internet Association (CTIA) and FDA will	 
jointly conduct research on mobile phone health affects. Although
the initiative is funded solely by CTIA, FDA's active role in	 
setting the research agenda and providing scientific oversight	 
should help alleviate concerns about the objectivity of the	 
report. The media has widely reported on the debate over whether 
mobile phones can cause adverse health problems. Thus, the	 
federal government's role in providing the public with clear	 
information on this issue is particularly important. FDA has a	 
consumer information update on mobile phone health issues but has
not revised that data since October 1999. Consequently FDA does  
not discuss the significance of major, recently published	 
research studies that have been reported in the press. FDA said  
that it has not revised the update because the scientific picture
has not changed significantly.					 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-01-545 					        
    ACCNO:   A00956						        
  TITLE:     Telecommunications: Research and Regulatory Efforts on   
             Mobile Phone Health Issues                                       
     DATE:   05/07/2001 
  SUBJECT:   Cellular telephone 				 
	     Health hazards					 
	     Telecommunication industry 			 
	     Radiation exposure hazards 			 
	     Product safety					 
	     Public health research				 
	     Cancer research					 

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GAO-01-545
     
Report to Congressional Requesters

United States General Accounting Office

GAO

May 2001 TELECOMMUNICATIONS Research and Regulatory Efforts on Mobile Phone
Health Issues

GAO- 01- 545

Page i GAO- 01- 545 Mobile Phone Health Issues Letter 1

Scope and Methodology 2 Results in Brief 3 Background 5 Evidence Does Not
Demonstrate Adverse Health Effects, but

Additional Research Is Under Way 8 FDA and Industry Association Are
Following Up on an Earlier

Research Effort 15 FCC Set an Exposure Limit for Mobile Phones, but
Standardized

Testing Procedures Are Lacking 18 Key FDA and FCC Consumer Information
Efforts Have

Shortcomings 26 Conclusions 30 Recommendations for Executive Action 31
Agency Comments 32

Appendix I Comments From the Federal Communications Commission 34

Appendix II GAO Contacts and Staff Acknowledgments 38

Figures

Figure 1: Growth in U. S. Wireless Telephone Subscribers, 1985- 2001 6
Figure 2: The Electromagnetic Spectrum 7 Figure 3: FCC?s Mobile Phone SAR
Test Equipment 22 Contents

Page ii GAO- 01- 545 Mobile Phone Health Issues Abbreviations

ANSI American National Standards Institute CRADA cooperative research and
development agreement CTIA Cellular Telecommunications & Internet
Association EPA Environmental Protection Agency FCC Federal Communications
Commission FDA Food and Drug Administration IEEE Institute of Electrical and
Electronics Engineers NCRP National Council on Radiation Protection and
Measurements NIH National Institutes of Health OET Office of Engineering and
Technology SAR specific absorption rate TCB Telecommunications Certification
Body WTR Wireless Technology Research

Page 1 GAO- 01- 545 Mobile Phone Health Issues

May 7, 2001 The Honorable Joseph I. Lieberman Ranking Member Committee on
Governmental Affairs United States Senate

The Honorable Edward J. Markey Ranking Minority Member Subcommittee on
Telecommunications

and the Internet Committee on Energy and Commerce House of Representatives

The number of wireless telephone subscribers in the United States has
increased at an extraordinary rate- from 16 million in 1994 to an estimated
110 million by 2001. The rapid adoption of wireless telephones, especially
handheld mobile phones, 1 has occurred amidst controversy over whether this
technology poses a risk to human health. Like other devices that transmit
radio signals, mobile phones emit radiofrequency energy. At high power
levels, radiofrequency energy can rapidly heat biological tissue and cause
damage, such as burns. Mobile phones operate at power levels well below the
level at which such heating effects occur. However, an issue that has been
the subject of research and debate for several years is whether long- term
exposure to low- level radiofrequency energy from mobile phones could cause
other types of adverse health effects, such as cancer.

In 1994, we reported on the status of scientific knowledge about potential
health risks of radiofrequency emissions by mobile phones and the federal
government?s regulatory actions to ensure the safety of mobile phones. 2 We
noted at the time that the Food and Drug Administration (FDA) and

1 In this report, we use the term ?mobile phones? to refer to handheld
cellular phones, as well as the newer personal communications services (PCS)
devices that deliver voice, data, and images. Each is commonly held to the
ear when making calls, thereby bringing the user?s head close to the
device?s antenna and the radiofrequency energy being emitted. Our definition
excludes cellular car phones and transportable ?bag? phones, where the
antenna is not located next to the user?s head.

2 Telecommunications: Status of Research on the Safety of Cellular
Telephones (GAO/ RCED- 95- 32, Nov. 4, 1994).

United States General Accounting Office Washington, DC 20548

Page 2 GAO- 01- 545 Mobile Phone Health Issues

the Environmental Protection Agency (EPA) believed that there was
insufficient evidence to determine whether exposure to low- level
radiofrequency energy presents a human health risk. Given the state of
scientific knowledge, they told us that they did not have a basis for taking
regulatory actions on mobile phones. Our report also discussed federal and
industry research efforts that were under way at that time to learn more
about potential effects of mobile phones.

At your request, we are providing an update on several issues related to
mobile phone health and regulatory issues. Specifically, you asked us to
address the following questions:

 What is the general status of scientific research on mobile phone
radiofrequency energy as it relates to human health, including current
activities of federal agencies in sponsoring, conducting, or overseeing
ongoing and planned research?

 What is the status of the cooperative research and development agreement
between FDA and the Cellular Telecommunications & Internet Association
(CTIA), a trade association representing the wireless industry, 3 to follow
up on research previously sponsored by the association?

 How has the federal government set the radiofrequency exposure limit for
mobile phones and how does it ensure compliance with it?

 What key actions are federal agencies taking to inform the public about
issues related to mobile phone health effects?

To provide an update on the general status of the scientific research on
mobile phone health effects, we reviewed reports by organizations such as
FDA, the National Institutes of Health (NIH), the World Health Organization,
and by expert panels convened by the governments of the United Kingdom,
Canada, and Australia that have reviewed and assessed the peer- reviewed
literature on the subject. We also interviewed representatives of these
organizations, as well as other scientists prominent in the field of
radiofrequency energy health effects in government, industry, and academia.
To determine the federal government?s role in sponsoring, conducting, or
overseeing research on mobile phone health effects, we gathered information
from federal agencies- including the Air Force, Army, EPA, the Federal
Communications Commission (FCC), FDA, National Cancer Institute,

3 In October 2000, the Cellular Telecommunications Industry Association
changed its name to the Cellular Telecommunications & Internet Association,
retaining the acronym CTIA. Scope and

Methodology

Page 3 GAO- 01- 545 Mobile Phone Health Issues

National Institute of Environmental Health Sciences, National Institute for
Occupational Safety and Health, National Institute of Standards and
Technology, National Science Foundation, Navy, and Occupational Safety and
Health Administration- on their activities, if any, in this area.

To describe and assess the cooperative research agreement between FDA and
CTIA, we conducted interviews with officials of these two organizations. We
also reviewed and analyzed documents related to the agreement, including the
agreement itself, FDA?s working group meetings, and CTIA?s request for
research proposals. We also discussed the cooperative research agreement
with parties outside of FDA and CTIA, including officials at several federal
agencies and individual mobile phone manufacturers, as well as independent
research scientists and public interest groups. This research agreement
follows up on an earlier industryfunded, 5- year research effort run by
Wireless Technology Research (WTR). We spoke to the former chairman of WTR,
as well as several members of its peer review board and some of the research
scientists that WTR funded. We also reviewed documentation related to WTR,
including reports that it published, as well as correspondence between WTR
and federal agencies, its peer review board, and other parties.

To evaluate issues related to standard setting, testing, and public
information, we reviewed federal laws and regulations related to
radiofrequency energy and safety standards for mobile phones. We also met
with officials at FCC, FDA, EPA, and other agencies to discuss their
regulatory roles and activities, and with industry representatives to
discuss their views and activities. To gain greater context on all of the
objectives, we also interviewed representatives of nonindustry,
nongovernment organizations with an interest in mobile phone safety,
including consumer groups, advocates, and labor unions.

Our review focused on health issues related to the radiofrequency energy
emitted from handheld mobile phones. It did not include issues related to
emissions from network base stations, the potential effects of mobile phone
emissions on medical devices, or on safety issues related to using a mobile
phone while driving. We performed our review from July 2000 through April
2001 in accordance with generally accepted government auditing standards.

The consensus of FDA, the World Health Organization, and other major health
agencies is that the research to date does not show radiofrequency energy
emitted from mobile phones to have adverse health effects but Results in
Brief

Page 4 GAO- 01- 545 Mobile Phone Health Issues

there is not yet enough information to conclude that they pose no risk.
Although most of the epidemiological and laboratory studies conducted on the
issue have found no adverse health effects, the findings of some studies
have raised questions about possible cancer and noncancer effects that
require further investigation. The World Health Organization has identified
priorities for further research- including additional epidemiological,
laboratory, and animal studies- and a number of major initiatives are under
way, particularly in Europe, to address these research priorities. The U. S.
government sponsors and supports some of the research; overall this
represents a small portion of the total worldwide research effort.

In 1993, CTIA created a nonprofit organization to fund research on the
health effects of mobile phone emissions. Although some useful research was
conducted, many scientists and government and industry officials that we
spoke with raised questions about the productivity and accountability of
that organization. In June 2000, a new industry- funded research initiative
began that is largely focused on following up on the results of this earlier
industry research effort. Unlike the prior effort, this new one is a
cooperative research and development agreement that involves direct
participation by FDA. CTIA had declined FDA?s offer to conduct a joint
research program in the early 1990s, but CTIA officials told us that they
now believe FDA?s involvement will provide additional accountability and
scientific credibility to the new effort.

In 1996, FCC, which is responsible for regulating mobile phones, established
rules setting a limit for human exposure to radiofrequency energy from
mobile phones. These rules are based on criteria developed by private
standards- setting organizations and input from other federal agencies,
including FDA. Manufacturers are responsible for testing mobile phones to
certify compliance with FCC?s exposure limit. However, a major engineering
organization has not yet completed a long- standing effort to develop
uniform procedures for this testing, the lack of which significantly
increases variability in test results. FCC has been revising its own
nonmandatory guidance on testing procedures, but has not yet issued it. In
addition, FCC and FDA differ on how the measurement uncertainty inherent in
testing is treated in determining compliance with radiofrequency safety
limits. In the area of staffing, FCC has been relying heavily on one staff
specialist in radiofrequency exposure issues to review manufacturers? test
results for compliance with FCC?s exposure limit and to perform some in-
house testing of mobile phones. FCC has attempted to recruit an additional
specialist but says it is having trouble competing with the private sector
for qualified applicants.

Page 5 GAO- 01- 545 Mobile Phone Health Issues

The media has given widespread attention to the debate over whether mobile
phones can cause adverse health effects; thus, the federal government?s role
in providing the public with clear information on this issue is particularly
important. FDA has a consumer information update on mobile phone health
issues, but it has not been revised since October 1999, and consequently
does not discuss the significance of major, recently published research
studies that have been reported and debated in the media. FDA told us that
the update has not been revised because the scientific picture has not
changed significantly since then. Consumers, however, have no way of knowing
this from the update and may be left in doubt about FDA?s views on recent
research developments. For its part, FCC makes information on radiofrequency
exposure issues publicly available, but this information is typically at a
level of technical detail that is not well- suited to a general audience.
These shortcomings in consumer information are a particular cause for
concern because the industry is including information from both FDA and FCC
with most new mobile phones. This report makes recommendations to FCC for
improving its review of mobile phone testing and to FCC and FDA for
improving consumer information on radiofrequency exposure and health issues.

The United States has experienced a dramatic growth in the number of
wireless telephone subscribers since nationwide cellular service became
available in the mid- 1980s. In 1994, 16 million Americans were subscribers.
By 2001, subscribership had reached an estimated 110 million (see fig. 1)
and is projected to have strong growth for the foreseeable future. Growth
has been strong in other countries as well, with some experts projecting
that worldwide subscribership will reach about 1.2 billion by 2005. In
countries such as Austria, Finland, Italy, Norway, South Korea, and Sweden,
more than half the population are already subscribers. Background

Page 6 GAO- 01- 545 Mobile Phone Health Issues

Figure 1: Growth in U. S. Wireless Telephone Subscribers, 1985- 2001

Source: Cellular Telecommunications & Internet Association (estimates).

The pocket- sized mobile phone in common use today is a low- powered radio
transceiver (a combination transmitter and receiver) that uses radio waves
to communicate with fixed installations, called base stations or cell
towers. The base stations are networked to a central switching station that
directs a mobile phone call to the desired location, whether that is another
mobile phone or a traditional landline phone. The radio waves used by mobile
phones are a form electromagnetic radiation- a series of waves of electric
and magnetic energy that move together through space. The spectrum of
electromagnetic radiation comprises a range of frequencies from very- low-
frequency energy (such as electrical power), through visible light, to
extremely high- frequency radiation (such as X- rays and gamma rays), as
shown in figure 2. The portion of the electromagnetic spectrum used by
mobile phones- as well as other telecommunications services, such as radio
and television broadcasting- is generally referred to as the

?radiofrequency spectrum.? Frequencies in this part of the spectrum are also
used for some noncommunications applications, such as microwave ovens and
radar.

Estimated subscribers in millions 0 20

40 60

80 100

120 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998
1999 2000

Page 7 GAO- 01- 545 Mobile Phone Health Issues

Figure 2: The Electromagnetic Spectrum

Source: FCC.

As figure 2 shows, the electromagnetic spectrum includes ionizing and non-
ionizing radiation. Ionizing radiation, such as X- rays and gamma rays, has
energy levels high enough to strip electrons from atoms and molecules.
Exposure to ionizing radiation can cause serious biological damage,
including the production of cancers. Radiofrequencies, on the other hand,
are in the ?non- ionizing? portion of the electromagnetic spectrum, which
lacks the energy needed to cause ionization. However, radiofrequency energy
can produce other types of biological effects. For example, it has been
known for many years that exposure to high levels of radiofrequency energy,
particularly at microwave frequencies, can rapidly heat biological tissue.
This heating (? thermal? effect) can cause harm by increasing body
temperature, disrupting behavior, and damaging biological tissue. The
heating effect can also be usefully harnessed for household and industrial
applications, such as cooking food and molding plastics.

Mobile phones are designed to operate at power levels well below the
threshold for known thermal effects. 4 Consequently, the mobile phone heath
issue has generally focused on whether there are any adverse biological
effects from long- term or frequent exposure to low- power radiofrequency
emissions that are not caused by heating (? nonthermal? effects). There is
particular interest in determining whether using a mobile phone could in
some way cause or promote brain cancer, since a user?s

4 A mobile phone is designed to operate at a maximum power level of 0.6
watts- less than the amount of power needed to light a flashlight bulb- and
generally uses less than maximum power when operating close to a base
station. By contrast, household microwave ovens use between 600 and 1,100
watts of power.

Non- ionizing Ionizing Visible light

Power lines Radio and television

Microwaves Infra- red Ultra- violet X- rays Gamma rays Frequency (Hertz) 10
10 2 10 3 10 4 10 5 10 6 10 7 10 8 10 9 10 10 10 11

Mobile phones 10 12 10 13 10 14 10 15 10 16 10 17 10 18 10 19 10 20 10 21 10
22 10 23 10 24 10 25 10 26 Radiofrequencies

Page 8 GAO- 01- 545 Mobile Phone Health Issues

head absorbs some radiofrequency energy when the phone is held to the ear
during a call. 5

According to FDA and others, the research to date does not show that mobile
phone radiofrequency emissions have adverse health effects but there is not
enough information at this point to conclude that these products are without
risk. While most epidemiological and laboratory studies related to the
radiofrequency emissions of mobile phones have found no adverse health
effects, the results of some studies have raised questions that require
further research. The World Health Organization, an agency of the United
Nations, has identified priorities for this research, and a number of
projects are under way internationally to address many of these priorities.
The U. S. government sponsors and supports some of the research; overall,
this represents a small portion of the total worldwide research effort.

A number of studies have been conducted on the possible health effects of
radiofrequency emissions from mobile phones. FDA?s position, first stated in
1993 and still in place today, is that the research to date does not show
that radiofrequency emissions from mobile phones have adverse health
effects. However, according to FDA, there is not enough information at this
point to conclude that the phones pose no risk. Several international
bodies, including the World Health Organization 6 and expert panels
commissioned by the British 7 and Canadian 8 governments, have drawn similar
conclusions. All of these bodies conclude that while most of the studies
related to mobile phone radiofrequency emissions have found no

5 The mobile phone health issue came to national attention in 1993 after a
lawsuit was brought against some mobile phone companies by a Florida man
claiming that his wife?s use of a mobile phone caused her brain cancer. The
industry has prevailed in this and other suits that have been brought.
Recently, a number of new lawsuits have been filed.

6 World Health Organization, ?Electromagnetic Fields and Public Health:
Mobile Telephones and Their Base Stations,? Fact Sheet No. 193 (2000). 7
Independent Expert Group on Mobile Phones, ?Mobile Phones and Health,?
National Radiological Protection Board (UK) (Apr. 1999). 8 Royal Society of
Canada, ?A Review of the Potential Health Risks of Radiofrequency Fields
From Wireless Telecommunication Devices.? Expert panel report prepared for
Health Canada (1999). Evidence Does Not

Demonstrate Adverse Health Effects, but Additional Research Is Under Way

Research to Date Does Not Demonstrate Adverse Health Effects, but Is Not
Conclusive

Page 9 GAO- 01- 545 Mobile Phone Health Issues

effect on human health, some studies that have suggested the existence of
biological effects require further investigation.

A number of factors makes it difficult to draw definitive conclusions from
the existing research about the potential health effects of mobile phones. A
relatively large body of research exists on the health effects of
radiofrequency energy in general, but most of this research has focused on
short- term exposure of the entire body, not on the longer- term exposure of
the head that is characteristic of mobile phone use. In addition, much of
the research to date has investigated the health effects of emissions at
frequencies different from those used by mobile phones; it is not clear how
possible health effects found at one frequency on the radiofrequency
spectrum apply to other frequencies on the spectrum. Furthermore, much of
the research focusing on mobile phones has tested the emissions of analog
phones rather than of digital phones, which are rapidly becoming the
standard technology. A few researchers have hypothesized that digital
phones, which transmit messages as discontinuous pulses, could have
different biological effects from analog phones, which transmit messages
using a continuously varying radio wave. However, according to FDA, at this
point the available scientific literature does not demonstrate convincingly
that the biological effects of radiofrequency exposure differ based on
specific frequency, or on whether the signal is analog or digital.

Two major categories of studies are used by scientists to assess whether
mobile phones present a health risk: epidemiological studies and laboratory
studies. Epidemiological studies, sometimes called human health studies,
investigate the associations between health effects and the characteristics
of people and their environment. Laboratory studies, which can include
studies on animals, biological tissue samples, isolated cells, or human
volunteers, are used to try to determine a causal relationship between a
risk factor and human health, and the mechanism through which that
relationship occurs.

Several epidemiological studies published in peer- reviewed scientific
journals have been conducted on the health effects of radiofrequency
emissions from mobile phones. Among them is a study of mobile phone users in
Denmark from 1982 through 1995 that found no association between phone use
and the incidence of brain or certain other cancers. 9

9 C. Johansen and others, ?Cellular Telephones and Cancer- A Nationwide
Cohort Study in Denmark,? Journal of the National Cancer Institute, Vol. 93,
No. 3 (2001), pp. 203- 207. Epidemiological Studies

Page 10 GAO- 01- 545 Mobile Phone Health Issues

This study included more than 420,000 mobile phone subscribers, although
more than two- thirds of them had been subscribing to mobile phone service
for less than two years. Two other studies, one of which was conducted by
the National Cancer Institute, compared the frequency and duration of mobile
phone use of brain tumor patients and control patients from 1994 to 1998. 10
, 11 These studies, too, found no association between mobile phone use and
an increased risk for brain tumors. A small Swedish study also did not find
an association between the amount of use of mobile phones and the risk of
brain tumors. The investigators reported an association between the side of
the head on which the tumor occurred and the side of the head where the
mobile phone was used, but this was based on a small number of brain tumor
cases. 12 In addition, a study of about 250,000 U. S. mobile phone customers
found that the overall mortality rates of the users of handheld mobile
phones were similar to the users of car phones (where the antenna is not
held close to the head). 13

Epidemiological studies, by nature, have certain limitations. They are not
good at detecting increases in risks that are small, and they generally
cannot, on their own, demonstrate a cause- and- effect relationship. In
addition, because mobile phones have been in widespread use for only a few
years, epidemiological studies have limited value in providing information
about a possible association with cancers that may have long latency
periods. For example, the National Cancer Institute said that its brain
cancer study was not sufficient to evaluate the long- term effects of mobile
phone use and was not large enough to rule out small increases in the risk
of brain tumors in general and larger increases in the risk for different
subtypes of brain tumors. If there is an increased risk of brain tumors due
to the use of mobile phones that only appears after 5 years or more, or only
among very heavy users, it is probable that this study would have failed to
detect it. For these reasons, experts we spoke with told us that
epidemiological studies, while useful, are only one piece of a larger

10 P. Inskip and others, ?Cellular- Telephone Use and Brain Tumors,? New
England Journal of Medicine, Vol. 344, No. 2 (2001), pp. 79- 86. 11 J.
Muscat and others, ?Handheld Cellular Telephone Use and Risk of Brain
Cancer,? Journal of the American Medical Association, Vol. 284, No. 23
(2000), pp. 3001- 3007. 12 L. Hardell and others, ?Use of Cellular
Telephones and the Risk for Brain Tumours: A Case- Control Study,?
International Journal of Oncology, Vol. 15, No. 1 (1999), pp. 113- 116. 13
K. J. Rothman and others, ?Overall Mortality of Cellular Telephone
Customers,? Epidemiology, Vol. 7, No. 3 (1996), pp. 303- 305.

Page 11 GAO- 01- 545 Mobile Phone Health Issues

body of evidence that must be evaluated to assess the health effects of
mobile phones.

Laboratory studies have been conducted to try to determine the effect of
radiofrequency emissions from mobile phones on individual human or animal
cells, on laboratory animals, or on human test subjects. Studies testing
individual cells have exposed samples of human or animal cells to
radiofrequency emissions over a range of dose rates, durations, and
conditions, and then examined the cells to try to detect any changes. The
great majority of these cellular laboratory studies have shown no biological
effects, but some studies warrant further additional attention, according to
FDA. For example, when researchers performed a battery of tests to assess
the effects of exposure to mobile phone radiofrequency energy on the genetic
material of blood cells, one type of test, known as a micronucleus assay,
detected changes in the genetic material, a common precursor to cancer. 14
FDA says that because the data already in the literature on this topic are
conflicting, follow- up research is necessary.

Animal testing related to mobile phone health effects involves exposing
laboratory animals (such as rats and mice) to radiofrequency emissions and
then examining the animals for changes, compared with a control group, in
disease or death rates. This kind of testing has the advantage of allowing
researchers to study the effect of radiofrequency emissions on a fully
functioning animal system, but it is also limited since the biological
effects on rats and mice may not be the same as those on human beings. FDA
says that the small number of animal studies that have investigated the
effects of radiofrequency exposures characteristic of mobile phones have
shown conflicting results, but a few studies have suggested that such
exposure could accelerate or contribute to the development of cancer in
laboratory animals.

Laboratory studies on human volunteers have investigated whether
radiofrequency exposure has certain noncancer effects, such as neurological
changes or changes in blood pressure. Some of these studies have reported
effects, including changes in brain activity, reaction times, and sleep
patterns. According to the World Health Organization, these

14 R. Tice and others, ?Tests of Mobile Phone Signals for Activity in
Genotoxicity and Other Laboratory Assays,? presented at annual meeting of
the Environmental Mutagen Society (Mar. 29, 1999). Laboratory Studies

Page 12 GAO- 01- 545 Mobile Phone Health Issues

effects are small and have no apparent health significance, but more studies
are needed to try to confirm these findings.

In 1996, the World Health Organization, an agency of the United Nations,
established the International Electromagnetic Fields Project, which seeks to
assess the health and environmental effects of exposure to electric and
magnetic fields, including radiofrequency fields emitted by mobile phones.
The agency notes that because the number of people using mobile phones has
grown so large, even small adverse effects on health could have major public
health implications. The goals of the project include coordinating
international research efforts in the area, assessing the scientific
literature, and identifying gaps in knowledge needing further research.

In 1998, the project developed an agenda for research priorities on the
health effects of electromagnetic fields. This agenda was developed in
collaboration with a number of international organizations, such as the
United Nations Environment Programme and the European Commission, as well as
independent scientific institutions in several countries. FDA officials told
us that they participated heavily in the development of this research agenda
and that they concur with it. Among the research priorities identified were
(1) additional large- scale animal studies that test the effect of long-
term exposure to radiofrequency energy; (2) studies that test health effects
other than cancer, such as memory loss and effects on the eye or inner ear;
and (3) at least two additional large- scale epidemiological studies of
people exposed to radiofrequency energy, including mobile phone users.

Officials at the World Health Organization and FDA told us that most of
these research needs are being addressed by ongoing or planned studies in
countries around the world. Because of the nature of many of these studies,
however, it may be several years before results are reported. Highlights of
efforts currently under way or planned include the following.

 The International Agency for Research on Cancer, a part of the World
Health Organization, is coordinating a series of large epidemiological
studies looking at whether there is an association between mobile phone use
and brain cancer. At least 13 countries are participating in the studies,
with results expected in 2004.

 The European Commission, under its research program known as the Fifth
Framework Programme, is sponsoring a number of studies on the health effects
of mobile phone emissions that are being funded primarily by the European
Commission and the mobile phone industry. The planned Efforts Under Way to

Conduct Additional Research

Page 13 GAO- 01- 545 Mobile Phone Health Issues

research includes large- scale animal studies designed to follow up on prior
research.

 FDA and CTIA have begun a cooperative research effort, discussed below,
that initially is focusing on two areas: (1) following up on the previously
cited micronucleus assay that found changes in the genetic material of blood
cells exposed to radiofrequency energy and (2) epidemiological studies.

 The National Toxicology Program, an interagency program headquartered at
NIH, began planning in 2000 a series of long- term animal studies looking at
the effect of long- term exposure to the radiofrequency emissions of mobile
phones. Officials at the program are determining how their efforts should be
coordinated with the European Commission?s planned animal studies.

 The United Kingdom?s Department of Health announced in December 2000 a
research program of up to $10 million on the possible health effects of
mobile phone emissions. While the specific areas of research to be conducted
are still under review, one strong area of focus is expected to be noncancer
effects, such as effects on brain function.

 In addition to these efforts, there are various other government-
supported national research programs on mobile phone health issues,
including programs in Australia, Finland, France, Germany, Italy, Japan, and
Sweden. Most of these programs are being coordinated with, or are being
conducted in collaboration with, the programs of the World Health
Organization and/ or the European Commission.

Many of the initiatives in mobile phone research are funded through a
combination of government and industry money. For example, mobile phone
research being done under the Fifth Framework Programme is being financed 40
percent by the European Commission and 60 percent by the mobile phone
industry. Similarly, the United Kingdom?s effort is being financed half by
the government and half by the industry. Much of the industry funding is
done through the GSM Association, which represents the wireless
communications industry, and the Mobile Manufacturers Forum, an
international consortium of mobile phone manufacturers that funds and
coordinates research efforts on the public health effects of mobile phones
and base stations. In addition, some individual mobile phone manufacturing
companies conduct their own internal research programs. For example,
Motorola has an in- house staff of five scientists and engineers that
researches radiofrequency exposure issues as they relate to public health.
Motorola also contracts out about $1 million a year on biological research
related to radiofrequency energy.

Page 14 GAO- 01- 545 Mobile Phone Health Issues

The U. S. government supports some research on the health effects of mobile
phone radiofrequency emissions; overall, this represents a small portion of
the research being done in the area worldwide. At present, only one agency,
NIH, is providing significant funding for research related directly to the
health effects of mobile phone emissions. Other agencies, such as FDA, are
providing technical and scientific support to research efforts funded by the
mobile phone industry, international organizations, and others. In addition
to its cooperative research and development agreement with CTIA, FDA is also
an active participant in the World Health Organization effort. For example,
an FDA official is serving as an external scientific adviser to the mobile
phone research activities being conducted under the European Commission?s
Fifth Framework Programme.

Depending on what tests it chooses to conduct, NIH?s National Toxicology
Program may spend as much as $10 million over several years on its longterm
animal tests of mobile phone radiofrequency exposure. The National
Toxicology Program is an interagency program headquartered at NIH?s National
Institute of Environmental Health Sciences that routinely solicits
nominations for toxicological studies. FDA nominated the review of mobile
phone radiofrequency exposure and is providing some input to NIH on the
experimental design of the animal studies. In addition, the Department of
Commerce?s National Institute of Standards and Technology is providing some
assistance to NIH on the design and measurement of the radiofrequency
exposure systems to be used in the program?s animal tests.

The Department of Defense has one of the world?s largest research programs
on the health effects of radiofrequency energy, with approximately 50 to 60
full- time staff working on the issue in Air Force, Army, and Navy programs.
Because the bulk of this research focuses on radar and on microwave-
emitting weapon systems, it is not specifically related to mobile phones,
but it does add to the general body of knowledge about the subject of
radiofrequency health effects. One study being conducted by the Air Force,
however, is closely related to mobile phone health effects- a $200,000 study
on whether the low- intensity radiofrequency emissions characteristic of
some mobile phones have an effect on the protective barrier that prevents
the brain from being harmed by certain substances in the blood.

EPA does not currently sponsor or conduct any research related to mobile
phone health effects. EPA used to have a substantial in- house program of
research on radiofrequency energy, but it was largely eliminated in the U.
S. Government Is

Supporting Some Research on Mobile Phone Health Effects

Page 15 GAO- 01- 545 Mobile Phone Health Issues

1980s for budgetary reasons. However, EPA scientists with expertise in the
area play an active advisory role with regard to research conducted by other
federal agencies, foreign governments, and private researchers, and with
regard to regulatory actions by FCC.

In 1993, CTIA created a nonprofit organization to fund research on the
health effects of mobile phone emissions. Although some useful research was
conducted, questions have been raised about the productivity and
accountability of that organization. A new industry- funded research
initiative began in June 2000 that is largely focused on following up on the
results of two studies under this previous effort. Unlike the prior effort,
this new one involves direct participation and oversight by FDA.

Responding to public concern that mobile phones may cause health problems
such as brain cancer, CTIA, a trade association representing wireless
telecommunications manufacturers and service providers, met in the early
1990s with FDA officials to discuss a possible research effort related to
mobile phone health effects. FDA proposed that the two organizations engage
in a cooperative research effort, but CTIA declined primarily because, they
told us, they feared that government involvement would add bureaucratic
complexity that would slow down the effort. Instead, on its own, CTIA
established the Scientific Advisory Group on Cellular Telephone Research,
whose goal was to develop, fund, and manage a research program assessing
whether mobile phones pose a public health risk and, if so, what should be
done to mitigate that risk. CTIA committed $25 million over 5 years to the
group. Using input from outside scientists, the Scientific Advisory Group
developed a research agenda that included multidisciplinary studies
involving epidemiology, cell cultures, test animals, and dosimetry (the
measurement of radiation). The group?s activities were reviewed by the Peer
Review Board on Cellular Telephones, a board of outside scientists
coordinated through Harvard University?s Center for Risk Analysis.

In our 1994 report on mobile phone safety, we noted that the Scientific
Advisory Group was being directly funded by CTIA on a month- by- month
basis, an arrangement that could have raised questions about the objectivity
and credibility of the research effort. In 1995, the Scientific Advisory
Group was transformed into Wireless Technology Research, L. L. C. (WTR), a
nonprofit organization financed by, but autonomous from, CTIA. WTR?s
structure was designed to maintain independence from industry control.
However, several representatives of federal agencies and FDA and Industry

Association Are Following Up on an Earlier Research Effort

Earlier Industry Research Effort Was Controversial

Page 16 GAO- 01- 545 Mobile Phone Health Issues

industry, as well as members of WTR?s Peer Review Board, told us they
believe that the structure set up for WTR resulted in too little
accountability. WTR had a three- person board of directors, but the chairman
of this board also served as the day- to- day manager of WTR?s activities
and did not report directly to CTIA or to any other body.

Our 1994 report recommended that FDA and EPA, in coordination with FCC, work
with the Scientific Advisory Group to maximize the usefulness, independence,
and objectivity of the group?s research effort. However, in the end, no
federal agency had a role overseeing WTR?s research activities. FDA
officials told us that they did not take an oversight role in WTR because it
was a private organization not under FDA?s control and that, in any case,
WTR rarely solicited input from FDA and did not always follow the input that
was given.

WTR spent about $28 million over 5 years, including about $25 million for
research on the health effects of mobile phone emissions. A broad array of
scientists and government and industry officials we spoke with said that
some of the research sponsored by WTR was useful. However, they questioned
both the type of projects WTR selected and the amount of research that was
produced, given the financial resources it had available. In addition, WTR?s
Peer Review Board raised concerns about WTR?s management in a July 1997
letter to the chairman of WTR. Among other issues, the board expressed
concern that WTR was not always open and transparent, particularly with
regard to its finances, and that decisions about the direction of its
research agenda did not always follow the advice of outside experts. The
chairman of WTR told us that in retrospect WTR should have been more
transparent about its work and its finances. However, he said that WTR?s
research agenda incorporated the input of a wide number of outside experts.
He also said that WTR?s mission was broader in scope than just sponsoring
research; it included tracking the emerging scientific information on the
topic and identifying strategies for mitigating any public risk.

The WTR effort eventually became caught up in public controversy. In May
1999, near the end of WTR?s funding period, the chairman of WTR issued a
statement that while the results of WTR research did not show a need for
public health intervention, the preliminary findings of two studies raised
concerns that warranted follow- up research. The chairman stated that one
study (see fn. 14) had found that human blood cells exposed to mobile phone
frequency radiation showed genetic damage in the form of micronuclei, which
is often considered a precursor to cancer. The second study (see fn. 11) was
an epidemiological study that, according to the

Page 17 GAO- 01- 545 Mobile Phone Health Issues

chairman, found a statistically significant risk of a certain rare type of
tumor. However, the findings of this study were preliminary, the analysis of
the data had not yet been completed, and the study had not yet been fully
peer- reviewed or published. In addition, the principal researcher of this
study disagreed with the chairman?s interpretation of his findings. The
chairman of WTR told us that he decided to report on these studies before
they were published because the potential public health threat of mobile
phones made it important to report on the research developments as soon as
possible.

In the wake of the WTR controversy, CTIA decided to fund a research effort
that would follow up on the two studies conducted under WTR that had raised
questions, as well as assess what further research might be needed. The
vehicle for this follow- up work is a cooperative research and development
agreement (CRADA), signed in June 2000, between CTIA and FDA. In contrast to
WTR, which had a broad mission, the scope of the CRADA is limited to
addressing the concerns raised by the two previous studies and assessing
what further research might be needed. Overall, the research planned under
the CRADA represents a small piece of the ongoing research worldwide related
to mobile phone safety, government officials and scientists in the area told
us.

Unlike the WTR effort, the CRADA involves the direct participation of FDA.
CTIA officials told us that their experience with WTR taught them that FDA
involvement would be beneficial because it would add accountability and
scientific credibility to the new research effort. FDA?s role in the CRADA
is to (1) determine what types of research studies should be conducted, (2)
evaluate and prioritize the research proposals received, and (3) review and
assess the results of the research. CTIA is administering the process for
procuring the research, and the research studies themselves are being
conducted by third parties via contracts with CTIA. Because these are
private contracts, CTIA says they will not be made publicly available,
although it does plan to release highlights of the contracts? provisions.

All of the research, as well as all costs incurred by FDA, is being paid for
by CTIA, which retains the final authority to decide which proposals are
chosen and funded. Thus, in contrast to WTR, the CRADA will not include a
division between the funding source and management of the research. However,
CTIA has said it intends to follow FDA?s recommendations concerning the
research agenda. The request for proposals that CTIA issued in September
2000 for the first set of studies incorporated FDA?s New Industry Research

Effort Involves Federal Oversight

Page 18 GAO- 01- 545 Mobile Phone Health Issues

recommendations with no changes. CTIA and FDA also told us they expect that
the contracts with researchers will include provisions to ensure that the
research results are published in peer- reviewed journals and that the
research data are owned and controlled by the researcher, not by CTIA.

An essential element in building public confidence about the independence
and objectivity of this follow- up research effort is keeping the CRADA
process open and accessible to the public. The FDA working groups that are
developing research recommendations hold publicly announced open meetings.
In addition, the research agendas that the working groups propose and the
requests for proposals that CTIA issues are publicly available. However, at
the time we completed our audit work, FDA had not yet decided the extent to
which it would make public its recommendations to CTIA on which proposals to
fund. If these recommendations are not publicly available in some form, it
will not be possible to ensure that CTIA is following FDA?s recommendations.
FDA officials told us that making their full recommendations public,
including individual reviewers? comments, would undermine the review
process, which depends on anonymous reviewers providing candid critiques of
research proposals. However, they said that they are considering ways of
providing the public with a summary of their recommendations that would
still protect the integrity of the review process.

Although several federal agencies are involved in radiofrequency safety
issues, FCC is responsible for regulating mobile phones. In 1996, FCC
established rules setting a human exposure limit for radiofrequency energy
from mobile phones, based on criteria developed by private standardsetting
organizations and input from other federal agencies. Manufacturers are
responsible for testing mobile phones to certify compliance with FCC?s
exposure limit, but the industry does not have uniform testing procedures,
which significantly increases variability in test results. An international
standards- setting organization has been working since 1997 to develop
uniform testing procedures. This effort is nearing completion, but there are
still some testing issues to resolve. FCC has revised its own nonmandatory
guidance on testing to reflect the procedures being developed by the
standards- setting organization. However, FCC is waiting for the
organization to complete its effort before issuing the revised guidance. In
the area of staffing, FCC has been relying heavily on one staff specialist
in radiofrequency exposure to review manufacturers? test results for
compliance with FCC?s exposure limit and to perform some in- house testing
of phones. FCC has attempted to recruit an additional specialist but FCC Set
an Exposure

Limit for Mobile Phones, but Standardized Testing Procedures Are Lacking

Page 19 GAO- 01- 545 Mobile Phone Health Issues

says that it is having trouble competing with the private sector for
qualified applicants.

Under the Federal Radiation Council Authority, transferred to EPA by
Reorganization Plan No. 3 of 1970, EPA is responsible for, among other
things, advising the President on radiation matters, including providing
guidance to all federal agencies on formulating protective standards on
radiation exposure. Upon presidential approval of EPA?s recommendation for
formulating standards, the pertinent agencies would be responsible for
implementing the guidance. EPA chairs the Radiofrequency Interagency Work
Group, which coordinates radiofrequency health- related activities among the
various federal agencies with responsibilities in this area. 15

Under the Radiation Control for Health and Safety Act of 1968, as amended,
FDA is responsible for establishing and carrying out a program, designed to
protect public health and safety, to control radiation from electronic
products. Under the law, FDA does not review the safety of radiation-
emitting consumer products such as mobile phones before they are marketed,
as it does with new drugs or medical devices. However, according to FDA, it
has the authority to take action, such as requiring manufacturers to replace
or recall phones, if they are shown to emit radiation at a level that is
hazardous to the user. The usual way that FDA fulfills its regulatory
responsibility is by evaluating industry- generated data from properly
conducted studies to determine whether they raise public health questions.
According to FDA, the evidence to date does not justify FDA?s taking
regulatory actions regarding mobile phones. The chief of FDA?s Radiation
Biology Branch said that the agency keeps abreast of scientific research on
the issue, and of changes in mobile phone technologies, to ensure that FDA
is aware if evidence of a health hazard emerges.

Under the National Environmental Policy Act of 1969, FCC is required to
consider whether its actions (including actions that may lead to human
exposure to radiofrequency energy) in authorizing communication equipment
significantly affect the quality of the human environment. In 1985, FCC
adopted an exposure limit for radiofrequency energy based on

15 Members of the working group are EPA, FCC, FDA, the National Institute
for Occupational Safety and Health, the National Telecommunications and
Information Administration, and the Occupational Safety and Health
Administration. NIH also participates in the working group. Regulatory Roles
and

Responsibilities of Federal Agencies

Page 20 GAO- 01- 545 Mobile Phone Health Issues

standards developed by the Institute of Electrical and Electronics
Engineers, Inc. (IEEE) 16 and subsequently approved and issued by the
American National Standards Institute (ANSI). 17 These standards covered
radiofrequency emissions of high- power devices, such as broadcast towers,
but not low- power devices, such as mobile phones. In 1993, FCC began
updating its radiofrequency exposure limits to reflect subsequent changes
made to the ANSI/ IEEE standard, which was similar to the limits developed
by the National Council on Radiation Protection and Measurements (NCRP). 18
The Telecommunications Act of 1996 required FCC to complete action to
prescribe and make effective rules concerning the environmental effects of
radiofrequency emissions. 19 Later that year FCC implemented, for the first
time, radiofrequency exposure limits that included mobile phones. Because
FCC is primarily a regulatory agency and is not an expert on matters
pertaining to health and safety, it followed the recommendations of FDA,
EPA, and other health agencies and organizations in setting standards for
mobile phones.

The exposure limit adopted by FCC for mobile phones is based on the heating
effects of radiofrequency energy. It has been known for many years that
radiofrequency energy at high enough power can heat tissue, causing damage
to living organisms. The scientific measure used to characterize the amount
of radiofrequency energy absorbed by biological tissue is called the
specific absorption rate (SAR). 20 In scientific tests, animals had adverse
behavioral effects once they absorbed enough radiofrequency energy to
increase their body temperature by 1 degree Celsius. IEEE and NCRP
incorporated a substantial safety factor into their standards for general
human exposure by setting them at one- fiftieth the

16 IEEE is a membership organization that develops industry standards, among
other activities. 17 ANSI is a nonprofit, private- membership organization
that coordinates the development of voluntary national standards. 18 The
NCRP is a not- for- profit corporation chartered by the Congress to
formulate and disseminate information, guidance, and recommendations on
radiation protection and measurements.

19 See Section 704( b) of the Telecommunications Act of 1996, Pub. L. No.
104- 104, 110 Stat. 56 (1996). 20 SAR is the widely accepted measurement of
radiofrequency energy absorbed into the body in watts per kilogram (W/ kg)
averaged over some amount of tissue ranging from the entire body to 1 gram.
Exposure Limit for Mobile

Phones Is Derived From Heating Effects

Page 21 GAO- 01- 545 Mobile Phone Health Issues

exposure shown to cause adverse effects in animals. Because this limit is
based on whole- body exposure, it was adjusted to account for the fact that
mobile phones expose only a part of the body to radiofrequency energy. The
resulting limit adopted by FCC for mobile phones is that their SAR levels
may not exceed 1.6 watts per kilogram (W/ kg) averaged over one gram of
tissue. Some other countries have chosen to adopt a somewhat higher exposure
limit than FCC.

Because the only proven adverse health effects of radiofrequency exposure
are caused by heat, the exposure limit is not designed to address the
possibility of any non- heating- related effects, such as cancer. FCC says
that given the lack of evidence of a non- thermal effect, the current
exposure limit is reasonable, particularly since it incorporates a large
safety factor for known heating effects. 21 FCC added that because it has
neither primary jurisdiction nor expertise in health and safety matters, it
adopted a radiofrequency exposure limit based on determinations by expert
standard- setting organizations and input from various federal health and
safety agencies.

Manufacturers are continually introducing new models of mobile phones with
new features and designs. Before a new model can be put on the U. S. market,
it must receive a grant of equipment authorization from FCC. In their
equipment authorization applications, manufacturers must certify that their
mobile phones meet various FCC technical standards, including compliance
with FCC?s radiofrequency exposure limit. Technical information must be
provided upon request, including data on the procedures used to conduct SAR
tests on the phones.

Manufacturers may conduct the SAR tests themselves at their own facilities
or have the testing done for them by private testing laboratories. A typical
SAR testing set- up is shown in figure 3. A mold in the shape of an adult
torso or head is filled with a fluid mixture designed to simulate the
electrical properties of human tissue. A probe attached to a
computercontrolled mechanical arm is inserted into the mixture at various
locations, with the phone placed next to the outer surface of the mold. The
phone is made to transmit a signal at full power while the probe is moved

21 A federal court of appeals upheld FCC?s radiofrequency exposure
guidelines (Cellular Phone Taskforce v. FCC , 205 F. 3d 82 (2d Cir. 2000)),
and earlier this year the Supreme Court denied petitions for certiorari
challenging this decision. FCC Requires SAR Testing

Before Mobile Phones Are Marketed

Page 22 GAO- 01- 545 Mobile Phone Health Issues

through the mixture, measuring the radiofrequency energy that is being
absorbed at various locations. The phone is tested in several
configurations, such as with its antenna extended and retracted, and at
different frequencies. The phone?s certified SAR level is the highest SAR
level measured during these tests. In order to receive FCC authorization,
none of the SAR test results for the head or body can exceed FCC?s exposure
limit of 1.6 W/ kg averaged over 1 cubic gram of fluid.

Figure 3: FCC?s Mobile Phone SAR Test Equipment

Source: GAO.

Page 23 GAO- 01- 545 Mobile Phone Health Issues

SAR test results for mobile phones can vary substantially because of
measurement uncertainties and the use of different testing procedures.
Variations due to measurement uncertainties are the result of limitations
inherent in technological and human accuracy. For example, FCC officials
said that small differences in the way different technicians set up the
test, mix the tissue fluid, or calibrate the measurement instruments can
introduce variation into the test results. Variations also occur because
laboratories can use different testing procedures. When FCC established its
mobile phone radiofrequency exposure limit in 1996, the industry did not
have uniform standards for testing SAR levels. FCC published a technical
bulletin in 1997 to assist manufacturers in complying with its
radiofrequency exposure limits, but the bulletin was not intended to
establish mandatory procedures for testing mobile phones. 22 FCC made it
clear that test procedures other than those discussed in its guidance could
be acceptable if based on sound engineering practice. For example, a testing
facility may use a number of different procedures for positioning the
handset, even though small differences in the position of a phone can result
in large, unexpected changes in the energy absorption in the head. Other
important sources of variability due to differences in testing procedures
include the properties of the mixtures used to simulate human tissue, the
type of head model used, the type and calibration of the probe used to
measure the radiated electric field, and the methods for averaging SAR
measurements. FCC officials said that the combined effect of measurement
uncertainty and procedural variations could, in some instances, cause a
phone?s actual maximum SAR level to fall somewhere within a range of plus or
minus 50 to 60 percent (at a confidence interval of 95 percent) of the test
result.

Given the lack of standardized SAR testing procedures, FCC must evaluate the
procedures used by a manufacturer for certifying the SAR level of each new
phone model. To do this, FCC examines the test reports provided with the
manufacturer?s application for equipment authorization. This documentation
is supposed to include, among other things, a description of measurement and
computational uncertainties in the testing system used; the test positions
of the phone; the type of head model used; the properties of the simulated
tissue fluid; SAR computation parameters, procedures, and results; and other
key pieces of information. FCC

22 Supplement C to FCC?s Office of Engineering and Technology Bulletin 65,
Evaluating Compliance with FCC Guidelines for Human Exposure to
Radiofrequency Electromagnetic Fields (Dec. 1997). SAR Test Results Can Vary

Substantially

Page 24 GAO- 01- 545 Mobile Phone Health Issues

currently has one specialist in radiofrequency exposure who is responsible
for reviewing applications that involve SAR testing.

We found that FDA and FCC differ in whether or not they expect manufacturers
to incorporate measurement uncertainty in determining compliance with
radiofrequency safety limits. FDA rules state that microwave oven
manufacturers must take all measurement errors and uncertainty into account
when demonstrating compliance with FDA?s radiofrequency energy performance
standard for these devices. An FDA official said that this rule essentially
lowers a microwave oven?s maximum level of allowable radiofrequency energy
leakage by the margin of measurement uncertainty. FCC, on the other hand,
considers a phone to be in compliance if the manufacturer?s SAR test result
is within FCC?s exposure limit, without incorporating the measurement
uncertainty associated with the test result. However, to ensure compliance
with the radiofrequency exposure limit, FCC looks for specific test
procedures and parameters used by manufacturers that would tend to
overestimate SAR. In the reviewer?s judgment, if an applicant?s testing
procedures appear to contain irregularities or raise questions, the reviewer
can request additional supporting data or further SAR testing. FCC officials
responsible for drafting FCC testing guidance were not aware of FDA?s
different treatment of measurement uncertainty when we discussed it with
them. They told us that they intended to contact FDA to discuss this issue
and obtain FDA?s views and advice.

FCC says that standardizing SAR testing procedures could significantly
reduce the variability in test results and speed up the FCC authorization
process. In February 1997, IEEE began an effort to set uniform industrywide
testing standards. Staff from FDA and FCC participate in this effort. After
4 years of work, IEEE?s standards- setting committee has made considerable
progress in developing draft standards. Agreement appears to have been
reached on many of the important issues, including standardizing the
properties of the mixture that simulates human tissue and the testing
positions of the phone. However, IEEE?s draft standards have not yet been
finalized because some technical issues still need to be resolved within the
committee.

FCC considers the lack of uniform SAR testing standards to be a major
concern. In October 1999, following a media report raising questions about
SAR testing, FCC issued a press release stating that if the industry
standard- setting committees did not act promptly to finalize standardized
testing procedures, FCC would mandate action on its own. In keeping with
Standardization of SAR

Testing Procedures Still Not Completed

Page 25 GAO- 01- 545 Mobile Phone Health Issues

this statement, FCC officials said that they have developed a draft revision
of their 1997 guidance, which is more inclusive and incorporates features of
the testing standards that IEEE is developing. FCC officials said that the
issuance of their revised guidance is currently on hold pending the
completion of IEEE?s testing standards. When we asked if FCC could
immediately issue guidance based on those IEEE testing procedures that have
already been agreed upon, FCC officials said that this could be done through
an FCC public notice. They noted that they have already begun informally
advising applicants to use certain of the most widely accepted elements of
the test procedures under consideration by IEEE.

FCC officials said that although IEEE?s new testing standards will reduce
the variations in test results due to the use of different procedures, some
level of measurement uncertainty is unavoidable. Thus, FCC officials said
that, as with any measurement system, SAR tests can provide only a best
estimate of a phone?s maximum SAR level. As noted above, the degree of
measurement uncertainty depends on a number of factors, including the
calibration of the equipment, the precision with which the technician makes
the measurements, and the errors due to system instrumentation. Because of
these measurement uncertainties, FCC officials said that a phone?s actual
maximum SAR level could fall somewhere within a range of 30 percent above or
below the phone?s test results (at a confidence interval of 95 percent),
even with uniform IEEE testing procedures in place. An industry- funded
project conducted by the University of Maryland in cooperation with FDA will
attempt to determine more precisely the degree of measurement uncertainty
that can be expected with the new IEEE testing standards.

To verify the test data provided by mobile phone manufacturers, FCC is
planning to conduct spot tests of some phones? SAR levels at its Office of
Engineering and Technology laboratory. Although FCC officials had hoped to
have the facility operational by fall 2000, some needed equipment was still
being procured at the time of our review.

FCC officials noted that because FCC does not have the staff resources to
test every mobile phone model that it authorizes, they can only test a
sample of these phones. Even so, FCC faces a serious staffing problem in
carrying out this initiative. Currently, FCC has only one radiofrequency
exposure specialist to both oversee reviews of equipment authorization
applications that involve radiofrequency exposure evaluation (about 50 a
month, of which 15 to 20 are for mobile phones) and run the new testing
facility. FCC and FDA officials have characterized this one specialist as
FCC Plans to Test Some

Phones

Page 26 GAO- 01- 545 Mobile Phone Health Issues

being FCC?s key quality control point for determining whether mobile phones
comply with FCC?s exposure limits. FCC officials said that they have tried
to recruit another radiofrequency exposure specialist but were unable to
find a suitable candidate because it is difficult to compete with the
private sector for qualified individuals. They stated that they plan to
continue their recruiting effort. To help cope with the current staffing
situation, FCC recently trained members of its engineering staff to take
over reviewing SAR testing reports under the supervision of the specialist.
The goal is to have the specialist spend about half of his time overseeing
SAR reviews and the rest of his time on the actual testing of phones? SAR
levels.

FCC has also turned to Telecommunications Certification Bodies (TCB) to help
process equipment authorization applications. A TCB is a private
organization that FCC, the National Institute of Standards and Technology,
and the American National Standards Institute have accredited to review
applications and issue product authorization grants on behalf of FCC. TCBs
are processing approximately half of equipment authorization applications,
none of which involve SAR tests. Eventually, FCC plans to move the bulk of
its application processing to TCBs, including the approval of applications
that include SAR tests, while retaining oversight of the TCBs? activities.
At the time of our review, however, the transfer of additional authority to
the TCBs had been placed on hold because of a lack of published uniform test
procedures. In addition, FCC officials said that TCBs have experienced more
difficulties in their application reviews than initially anticipated. FCC
officials indicated that they are continuing their training and guidance
efforts to improve TCBs? overall performance. In the near term, all SAR
reviews will be performed at the FCC laboratory.

During the past year, as new research studies were published, the print and
broadcast media have presented a variety of assessments about the potential
health effects of mobile phones. Given this situation, the federal
government?s role in providing the public with clear information on this
issue is particularly important. FDA?s consumer information on mobile phone
health issues, however, has not been revised since 1999 and does not reflect
more recent studies and research developments. Both FCC?s Office of
Engineering and Technology and its Consumer Information Bureau provide the
public with information on radiofrequency exposure issues but do not meet
general consumers? need for clear and concise information. These
shortcomings are a cause for concern because the industry is including FDA?s
and FCC?s consumer information with most new mobile phones. Key FDA and FCC

Consumer Information Efforts Have Shortcomings

Page 27 GAO- 01- 545 Mobile Phone Health Issues

FDA has a short information document, found on its Web site, called

?Consumer Update on Mobile Phones.? The document, dated October 20, 1999,
states that the available scientific evidence does not demonstrate that
there are any adverse health effects associated with the use of mobile
phones. However, FDA adds that there is not enough evidence to know for
sure, either way, whether handheld mobile phones might be harmful. The
document discusses several research studies, including the two WTR studies
that are being followed up under the cooperative research and development
agreement between FDA and CTIA. For consumers who want to take simple
precautions to limit their exposure to mobile phone radiofrequency
emissions, FDA?s update mentions some steps, such as avoiding extended
conversations or using a headset while carrying the phone at the waist.

Although informative, the update has not been revised since 1999, and
consequently does not discuss the significance of major, recently published
research studies that have been reported and debated in the media. An FDA
official told us that the update had not been revised because the scientific
picture had not changed significantly since then. Consumers, however, have
no way of knowing this from the update and may be left in doubt about FDA?s
views on recent research developments. Another problem with the update is
that much of its discussion of health research is written in a technical
manner that may be confusing to the general public. This issue is
particularly important because CTIA has been using FDA?s consumer update as
part of its voluntary program that enables manufacturers of mobile phones to
receive CTIA certification that their phones meet certain performance,
safety, and labeling standards. CTIA officials estimate that 70 to 75
percent of the mobile phones currently sold in the United States are
certified under this program. One of the requirements for CTIA certification
is that manufacturers include the text of FDA?s ?Consumer Update on Mobile
Phones? in the packaging of the phones. According to FDA, however, this
document was not designed for mass distribution as an insert in mobile phone
packaging. Rather, the information was for use in responding to inquiries
received by FDA about the safety of mobile phones. FDA?s Consumer

Information Update Has Not Been Revised Since 1999

Page 28 GAO- 01- 545 Mobile Phone Health Issues

The consumers? primary source of information from FCC on radiofrequency
exposure is its Office of Engineering and Technology?s (OET) ?RF Safety
Program? Web page. 23 Among the documents found at this site is OET?s
?Questions and Answers About Biological Effects and Potential Hazards of
Radiofrequency Electromagnetic Fields.? 24 This is a well- written
presentation of radiofrequency radiation and SAR measurement. However,
because this document is long (over 30 pages) and technically detailed, it
does not satisfy the need of general consumers for clear, concise
information on this issue. Other OET documents on the mobile phone issue
also do not meet this need. For example, OET?s

?Radiofrequency Energy: Frequently Asked Questions? responds to the question
?Is it safe to use a cellular phone?? with technical details on industry
guidelines for SAR levels that do not answer the question and would baffle
most consumers. 25 OET officials said that the technical nature of
radiofrequency exposure and testing makes it difficult to develop a concise,
consumer- oriented document that does not oversimplify the issue.

This information shortcoming is particularly evident with regard to OET?s
recent initiative to provide the public with Internet access to its
equipment authorization database. This database includes SAR testing results
for mobile phones that have application receipt dates after April 15, 1998.
Consumers can access the database by entering a phone?s FCC identification
number (usually found on a label on the phone?s case) on the database?s
search screen. Some additional searching is needed to locate the document
that has the phone?s SAR number. For a recently authorized phone, the SAR
number is on the one- page authorization grant for that phone. For an older
phone, the consumer must examine a technical exhibit to locate the phone?s
SAR test results. Because the database was developed to support application
processing, it does not include an explanation of what SAR numbers measure
or what their

23 OET?s ?RF Safety Program? Web page address is http:// www. fcc. gov/ oet/
rfsafety/. 24 OET Bulletin 56 (4th edition, Aug. 1999). 25 This document
includes the question: ? Is it safe to use a cellular phone?? with this
answer:

?The ANSI/ IEEE and NCRP RF safety guidelines recommend that low- power
devices such as cellular hand- held phones not cause a localized exposure in
excess of specific absorption rate (SAR) of 1.6W/ kg. Studies of human head
models using cellular phones have generally reported that the SAR levels are
below 1.6W/ kg level as averaged over 1 gram of tissue under normal
conditions of use. However, some recent studies have reported higher peak
levels under ?worst- case? conditions that suggest the need for further
dosimetric studies.? FCC?s Consumer

Information Efforts Need Improvement

Page 29 GAO- 01- 545 Mobile Phone Health Issues

significance is in relation to the health issue. Without a context for SAR
numbers, consumers will have difficulty understanding what to make of the
SAR information they find.

OET officials noted that information on SARs is provided on its ?RF Safety
Program? Web page, which also contains instructions on using the equipment
authorization database. However, we found that this information does not
provide adequate consumer- oriented information on radiofrequency exposure
and SAR issues. In addition, consumers may access the database directly,
without first accessing any other FCC material, because organizations
outside of FCC are providing the database?s Web address to consumers. For
example, CTIA announced last summer that all new mobile phones receiving
CTIA certification after August 1, 2000, would include labeling on the
outside of the phone?s box that includes both the phone?s FCC identification
number and the Internet address for the equipment authorization database. 26

OET has been taking some actions to better respond to consumer inquiries on
the mobile phone safety issue. In June 2000, OET added a staff member whose
full- time job is to answer questions on radiofrequency safety issues that
come in by letter, e- mail, or OET?s public information telephone number
(about 300 telephone inquiries a month). Currently, OET is revising its
?Frequently Asked Questions? to include more and simpler information
regarding the mobile phone safety issue. It is not yet clear how well this
revision will meet the need for a consumer- friendly explanation of SAR
measurements and radiofrequency exposure issues.

Another part of FCC, the Consumer Information Bureau, provides the public
with information on many telecommunications topics, including mobile phones,
through its Web page and toll- free consumer information telephone number.
Here again, we found the lack of clear, consumeroriented information on
radiofrequency exposure and SAR measurement issues. For example, the
Bureau?s Web page for consumers contains a short brochure related to mobile
phones entitled, Market Sense: Cell Phones- Facts, Fiction, Frequency. The
brochure covers a variety of wireless service issues, but has only a couple
of sentences on radiofrequency exposure. Specifically, it puts the statement
?Cell Phones Cause Medical Problems? into the category of ?fiction,? noting
that ?[ t] here

26 These CTIA- certified phones will also include text material inside the
boxes that provides each phone?s SAR number and information on
radiofrequency exposure issues.

Page 30 GAO- 01- 545 Mobile Phone Health Issues

is no scientific evidence that proves wireless phone usage can cause cancer,
increased blood pressure, memory loss, or other health problems,? though
research is continuing. When they were asked to comment on it, OET officials
shared our concern that this characterization could be misleading, because
it implies that the health issue is settled. We also pointed out that the
Bureau?s Web page did not direct consumers to information resources on
radiofrequency exposure issues found elsewhere on the FCC Web site, such as
OET?s documents. After we brought these issues to the attention of officials
in the Consumer Information Bureau and OET, they began discussions to
improve this situation. By the time we concluded our review, the Bureau had
created Web links between its consumer Web page and OET?s RF Safety Web page
and began working with OET to revise the Market Sense brochure. Though these
steps to improve coordination are in the right direction, there is still a
need for a consumer- oriented FCC document that provides lay readers with
clear, concise, and accurate information on radiofrequency exposure and SAR
issues.

Scientific research to date does not demonstrate that the radiofrequency
energy emitted from mobile phones has adverse health effects, but the
findings of some studies have raised questions indicating the need for
further investigation. The U. S. government sponsors and supports some
research efforts on mobile phone health issues, but wider research efforts
are under way internationally. The World Health Organization has identified
priorities for research on mobile phone health issues, and a variety of
organizations in Europe, the United States, and elsewhere, have begun
efforts to address these research needs. Given the long- term nature of much
of the research being conducted- particularly the epidemiological and animal
studies- it will likely be many more years before a definitive conclusion
can be reached on whether mobile phone emissions pose any risk to human
health.

While limited in scope, the cooperative research and development agreement
between FDA and the mobile phone industry is among the research efforts
being undertaken internationally that may help provide answers. Although the
initiative is being funded solely by the industry, FDA?s active role in
setting the research agenda and providing scientific oversight should help
alleviate concerns about the objectivity of industryfunded research.
However, FDA has not yet decided the extent to which it will make public its
recommendations to CTIA as to which specific research proposals should be
funded. There is no way for the public to be Conclusions

Page 31 GAO- 01- 545 Mobile Phone Health Issues

sure that CTIA is following FDA?s recommendations unless these
recommendations are publicly available in some form.

There still are no standardized procedures on how phones should be tested
for compliance with FCC?s 1996 radiofrequency exposure limit. This results
in substantial variation in testing, complicating FCC?s review of
manufacturers? test results. This variation could be reduced with uniform
testing procedures, though the test results will still include some
unavoidable measurement uncertainties. Having only one specialist to oversee
the review of manufacturers? SAR testing and operate FCC?s inhouse mobile
phone test facility also creates a human capital problem for FCC. FCC
recognizes that additional resources are needed in this area, but is having
difficulty competing with the private sector for qualified individuals. 27

Given the prominence of the mobile phone health issue, FDA and FCC need to
provide the public with clear, accurate, and timely information so that they
can make informed decisions. The information that FDA and FCC provides
consumers on health and radiofrequency exposure issues is not always up to
date or written for a general consumer audience. Given that industry is
including information from FDA and FCC with most new phones, it is
particularly important that these shortcomings be corrected.

We recommend that the Chairman of the Federal Communications Commission take
the following actions:

 Direct the Office of Engineering and Technology to issue revised guidance
on SAR testing procedures to reduce variations in test results caused by a
lack of standardized procedures. This guidance should be kept current as
industry standards evolve.

 Direct the Office of Engineering and Technology to consult with FDA on the
advisability of adopting FDA?s method of incorporating measurement
uncertainty in determining compliance with radiofrequency safety limits, and
make the results of this communication publicly available.

 Direct the Consumer Information Bureau and the Office of Engineering and
Technology to work together to develop clear, consistent, and easily

27 FCC is not unique in this regard. See our discussion of federal human
capital issues in Major Management Challenges and Program Risks: A
Governmentwide Perspective (GAO- 01- 241, Jan. 2001). We have designated
federal agencies? strategic human capital management as a high- risk area
that needs urgent attention. Recommendations for

Executive Action

Page 32 GAO- 01- 545 Mobile Phone Health Issues

accessible consumer materials on mobile phone radiofrequency exposure
issues. In particular, these offices should modify the product authorization
database Web site so that it links consumers to clear, concise information
on radiofrequency exposure issues and the meaning of SAR data.

 Direct the Office of Managing Director, as part of human capital planning,
to develop a strategy for meeting the need for additional expertise in
radiofrequency exposure and testing issues.

In addition, we recommend that the Administrator of the Food and Drug
Administration direct the Center for Devices and Radiological Health to take
the following actions:

 Publicly report on the extent to which CTIA is following FDA?s
recommendations in choosing and funding the specific research proposals
conducted under the cooperative research and development agreement between
FDA and CTIA.

 Develop a new consumer update document that provides a current overview of
the status of health issues and research related to mobile phones. Because
the industry trade association requires manufacturers to include the text of
this document in the packaging of mobile phones that it certifies, the
document should be written with a broad consumer audience in mind. Given the
fast pace of developments on these issues, FDA should revise this document
as significant research and policy events occur.

We provided a draft of this report to NIH, FDA, and FCC for review and
comment. NIH recommended some technical changes, which we incorporated into
the report where appropriate. FDA said that the report accurately summarizes
the public health concerns relating to mobile phones, FDA?s role in
addressing these concerns, and the current state of the scientific
knowledge. FDA provided us with some technical changes, which we
incorporated into the report where appropriate. FDA also said our
recommendations to them- regarding the CRADA and consumer information
efforts- are consistent with FDA?s plans and goals, and that it expects to
implement them shortly.

FCC said that the report appropriately describes the roles of federal
agencies regarding radiofrequency energy health issues. It emphasized that
because FCC does not have primary jurisdiction or expertise in health and
safety matters, it relies on the guidance of other federal agencies and on
expert standard- setting organizations to set exposure limits. FCC also
provided certain clarifications to our draft, which we incorporated where
appropriate. It also described actions that are planned or underway to
Agency Comments

Page 33 GAO- 01- 545 Mobile Phone Health Issues

address issues raised in our report, including those related to staffing,
measurement uncertainty, and public information. FCC?s written comments and
our responses appear in appendix I.

As agreed with your office, unless you publicly announce its contents
earlier, we plan no further distribution of this report for 30 days after
the date of this letter. At that time, we will send copies to interested
congressional committees; Michael K. Powell, Chairman, Federal
Communications Commission; Dr. Bernard A. Schwetz, Acting Principal Deputy
Commissioner, Food and Drug Administration; Dr. Ruth Kirschstein, Acting
Director, National Institutes of Health; Mitchell E. Daniels, Jr., Director,
Office of Management and Budget; and other interested parties. We will also
make copies available to others upon request. If you have any questions
about this report, please call me at 202- 512- 2834. Key contacts and major
contributors to this report are listed in appendix II.

Sincerely yours, Peter Guerrero Director, Physical Infrastructure Issues

Appendix I: Comments From the Federal Communications Commission Page 34 GAO-
01- 545 Mobile Phone Health Issues

Appendix I: Comments From the Federal Communications Commission

See comment 1.

Appendix I: Comments From the Federal Communications Commission Page 35 GAO-
01- 545 Mobile Phone Health Issues

See comment 2.

Appendix I: Comments From the Federal Communications Commission Page 36 GAO-
01- 545 Mobile Phone Health Issues

Appendix I: Comments From the Federal Communications Commission

Page 37 GAO- 01- 545 Mobile Phone Health Issues

1. We added text that further emphasizes that FCC is not a health and safety
agency.

2. As we note in our report, FDA rules regarding microwave ovens state that
manufacturers must take into account all of the measurement errors and
uncertainty when demonstrating compliance with the radiofrequency energy
performance standard for these devices. The issue we are raising is whether
FCC should adopt a similar approach as part of its equipment authorization
process for mobile phones. We have changed our report to emphasize that we
are referring to differences in FDA?s and FCC?s approach to the
uncertainties associated with manufacturers? own testing. We look forward to
the outcome of FCC?s continued consultations with FDA on this issue. GAO
Comments

Appendix II: GAO Contacts and Staff Acknowledgments

Page 38 GAO- 01- 545 Mobile Phone Health Issues

Peter Guerrero (202) 512- 2834 John P. Finedore (202) 512- 2834

In addition to those named above, Jason Bromberg, A. Don Cowan, Keith
Cunningham, Gregory Ferrante, Janet Heinrich, and Mindi Weisenbloom made key
contributions to this report. Appendix II: GAO Contacts and Staff

Acknowledgments GAO Contacts Acknowledgments

(385870)

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