My comments: This paper was written in 2002 by Jamie Wisz
while a 3rd year law student at Harvard. Thirteen years later despite
the preponderance of peer-reviewed research evidence which indicates
that exposure to mobile phone radiation is harmful to humans, the FCC
maintains the same obsolete RF standards adopted in 1996 and cell phone
testing procedures have not been improved despite recommendations from the General Accountability Office, the American Academy of Pediatrics and other medical associations and consumer organizations.
Moreover, the FDA has
failed in its responsibility to protect public health. The agency's
efforts to promote research on cell phone radiation health effects have
been seriously deficient. The FDA recommended a major research project
on the health effects of exposure to second generation (2G) cell phone
radiation on rodents, but more than a decade later the National
Toxicology Program project has yet to publish a single result.
Below
are excerpts from Ms. Wisz's insightful analysis along with her policy recommendations. Perhaps the legal analysis she provided (not summarized
below) will be useful to lawyers who are interested in defending the
necessity for local and state cell phone "right to know" laws since the
FDA and FCC have shirked their responsibility to protect the American
public for almost two decades.light of the VW "dieselgate" scandal, some
scientists have become concerned about how easy it would be to rig a
cell phone to pass the FCC cell phone RF radiation certification test.
Ms. Wisz's paper is available from Harvard at the link below.
Abstract
In
recent years, the public has become concerned that the electromagnetic
radio-frequency radiation (RF radiation) emitted by cellular telephones
may pose serious health risks, including the risk of cancer. There are
over 110 million cell phone users in the United States and many of them
may not know that cell phones actually send electromagnetic waves into
the user's brain. Depending on how close the cell phone antenna is to
one's head, as much as sixty percent of the microwave radiation from the
phone is absorbed by, and actually penetrates the head, possibly
reaching as far as an inch-and-a-half into the brain. The problem is
that it is still unknown whether or not this RF radiation from cellular
phones actually causes any sort of damage to the user.
This
paper will explore many aspects of the issue of cellular phone
radiation. The first section of the paper will explain what RF
radiation is and provide an overview of the various scientific studies
which have examined the effects of RF radiation on health. The second
section of the paper will discuss and critique the regulatory responses
by the FDA and the FCC in the midst of this scientific uncertainty. The
third section of the paper will provide an overview of the judicial
treatment of cell phone radiation issues by exploring some of the recent
case law in this area. Finally, the last section of the paper will
provide policy recommendations for how the FDA and FCC should be responding to this potential health crisis.
Excerpts
The only thing that
is clear right now is the fact that it is still unknown whether or not
cell phone use can be deleterious to one's health. It also seems as if
conclusive scientific data on this topic may not be available for
another several years ....
... It should be noted that
there are various government agencies that are responsible for different
aspects of mobile phone safety. These agencies include the Food and
Drug Administration (FDA"), Federal Communications Commission (FCC"),
National Institute for Occupational Safety and Health, Environmental
Protection Agency, Occupational Health and Safety Administration,
National Telecommunications and Information Administration, and the
National Institutes of Health.79 The following section will focus on the
two agencies with the most responsibility in this area: the FDA and the
FCC.
FDA's Role
The FDA is
empowered by Congress to directly regulate electronic products that emit
radiation with regard to public health and safety. Therefore, the FDA
has the primary responsibility to respond to the concern over cellular
telephones. The FDA receives this enforcement authority through the
Electronic Product Radiation Control Provisions of the Federal Food,
Drug, and Cosmetic Act. The Radiation Control Provisions, originally
enacted as the Radiation Control for Health and Safety Act of 1968, are
located in Sections 531 through 542 of the Act ...
Currently, the
FDA does not review the safety of radiation-emitting consumer products
such as mobile phones before marketing, as it does with new drugs or
medical devices. 83 However, the agency does have the authority to take
action if mobile phones are shown to emit radiation at a level that is
hazardous to the user.84 \In such a case, the FDA could require the
manufacturers of mobile phones to notify users of the health hazard and
to repair, replace or recall the phones so that the hazard no longer
exists."85
For many years it seemed as if the FDA refrained from
exercising the full extent of its powers over the cell phone industry.
Instead, the FDA chose to take limited actions until the scientific
community could con firm the presence of hazards associated with
exposure to RF radiation.86 The FDA first took action in 1993, when it
met with representatives of the cellular telephone industry to discuss
the potential health problems associated with cell phones and possible
solutions.87 Since then, the FDA has worked with manufacturers in order
to seek ways to minimize human exposure to RF radiation.88 For example,
the FDA and manufacturers have discussed the advantages and
disadvantages of redesigning the placement of the antenna so that the
source of radiation is further away from the user's head.89
In
recent years, the FDA has also become more active in overseeing and
supporting research on the effect of RF radiation exposure on human
health. For instance, the FDA is working with the U.S. National
Toxicology Program as well as with groups of investigators around the
world to ensure that high priority animal studies are conducted to
address important questions about the effects of RF exposure.90 The FDA
has also urged the mobile phone industry to cooperate in providing
mobile phone users with the best possible information on what is known
about the possible effects of mobile phone use on human health.91 ....
Although
the FDA's more recent actions have been somewhat proactive, this was
not the case for many years. In fact, until the formation of the CRADA
in 2000, the FDA seemed content with waiting for the scientific results
from WTR's research on the health effects of mobile phones. However, WTR
was funded by the cellular telephone industry itself. Certainly it
seems as if there is a conflict of interest problem which arises from
the fact that the industry was allowed to do its own scientific testing
with little or no oversight.107 ....
At this point, the FDA has
not prescribed any standards for the cell phone industry. While it is
true that the FDA needs to become aware of the health effects of cell
phone radiation before any standards can be promulgated, up until June
of 2000, the FDA took virtually no steps towards advancing this
research. Due to the conflict of interest problem, reliance on the cell
phone industry to do their own scientific research was insufficient ...
As shown in the scientific studies discussed above, there was evidence
as early as the 1970's that exposure to EMF's could have a detrimental
impact on one's health.111 Certainly by the early 1990's there was
increasing evidence that cell phone radiation could be harmful.112 ....
...
since the EPRC provision puts the FDA in the lead role of protecting
the public health from cell phone radiation, the FDA simply acted too
slowly in reacting to this potential health concern. The last section of
this paper will make some additional suggestions as to what other
measures the FDA should currently take to ensure public knowledge and
safety in this area.
FCC's Role
The
FCC is required by the National Environmental Policy Act of 1969 to
evaluate the effect of emissions from FCC-regulated transmitters on the
quality of the human environment.113 On August 1, 1996, under intense
Congressional pressure to act, the FCC adopted and issued a new set of
RF radiation exposure guidelines that were applicable to cellular
telephones for the first time.114
Because the FCC does not consider
itself a health agency with the expertise to determine what levels of
radiation are safe, it turned to health experts (such as the FDA), and
radiation experts outside of the FCC for guidance on these
regulations.115 The FCC adopted exposure limits based on industry
standards established by the American National Standards Institute
(ANSI), the Institute of Electrical and Electronic Engineers (IEEE),
and the National Council on Radiation Protection and Measurements
(NCRP).116 These limits for cellular telephones are based on exposure
criteria quantified in terms of specifi c absorption rate (SAR), which
is a measure of the rate of RF absorption into the body.117 Cellular
telephones must be below the SAR limit of 1.6 watts/kg as averaged over
one gram of tissue.118 ....
There are many scientists and
commentators who argue that the FCC's guidelines are an ineffective and/or inadequate measure to guard against any of the potential risks of
RF radiation.122 According to some scientists, the FCC's guidelines are
flawed because they do not take into account the possibility that
weaker levels of RF radiation are just as harmful to human health as
stronger levels.123 ... Others argue that the FCC's exposure standards
are inadequate because they are limited to providing protection from
thermal effects and fail to address potential non-thermal e ffects.126
... Furthermore, there have been criticisms that the FCC's requirements
are so vague that a cell phone can pass the guidelines when tested in
one position and exceed maximum allowable levels when held in another
position.127
... these guidelines can only be as effective as
the scientific evidence behind them. Unfortunately, the FCC's radiation
emission guidelines were established in 1996, four years before the FDA
became actively involved in the research process. This fact underscores
the need for further research on the e ffect of radiation at various
levels. To reiterate, such research is currently underway; however, it
would have been more helpful had the research begun at an earlier date.
Proposed Policy on Cellular Phone Radiation Issues
As
mentioned in the section on regulatory responses, the FDA is currently
on the right path in promoting further research on cell phone radiation
and its effects on human health. However, I submit that the FDA could
and should do more. For instance, the FDA should require that all
cellular phones currently on the market must include inserts on the
FDA's Consumer Update on Mobile Phones. Currently, the addition of these
inserts is voluntary. The FDA has complete authority to require the
inclusion of these inserts under 21 U.S.C. x 360kk (a)(1), in which the
Secretary may require the attachment of warning signs and labels..."176
on such products. In addition, the FDA should require that all cell
phone companies' web pages have links to this consumer update, in an e
ffort to notify users of previously purchased cellular phones. This
requirement of including the FDA's Consumer Update on websites and with
all new phones, will allow cell phone purchasers to be fully aware of
the potential hazards of cell phone use.
Furthermore, the FDA
should require that all cellular phones on the market include an
external headset. Once again, the FDA has the power to impose this
requirement under 21 U.S.C. x 360kk (a)(1), as the Secretary can
prescribe performance standards for electronic products to control the
emission of electronic product radiation from such products..."177 There
is no question that use of an external headset greatly reduces the
amount of RF radiation that penetrates inside the cell phone user's
head. Since there are studies which suggest that this RF radiation may
be dangerous to human health, requiring inclusion of a headset with all
new cell phones is a relatively small price to pay for the prevention of
possible negative health effects. These headsets only cost about $5 -
$10 and will not be a major expense for the cell phone industry.178
FCC
standards also need to be improved. Although it is useful for each
phone to have a FCC identification number which can be used to obtain
information about that particular cell phone's radiation levels, it is
currently a somewhat obscure and difficult process. For instance, the
FCC number on many cell phones can only be viewed by removing the cell
phone battery. In addition, cell phone consumers are probably not even
aware that they can find this information unless they log on to the
FCC's website. The FDA, in accordance with its powers under the EPRC
provision should require that radiation levels of each cell phone model
are more clearly displayed on all phones, along with a brief description
of what these levels mean. Again, by providing this information, cell
phone purchasers will become more aware of the properties and potential
dangers of their particular phone. In addition, FCC standards should be
revised as more knowledge about the effects of differing levels of RF
radiation becomes available. Currently, as discussed earlier, the FCC's
standards seem somewhat arbitrary in relation to human health.
The
case law in this area shows us that there is consumer demand for more
information about the harms of cell phone use. There is also a demand
for increased safety precautions such as inclusion of headsets. The
Naquin case, and its lack of a preemption finding, illustrates the
belief by many that the FDA is not doing its job in providing this
information and/or precautions. If left to the courts, it is possible
that each state could prescribe its own standards for cell phones.
However, a national standard is much more desirable and efficient. This
is precisely why the FDA needs to impose the further regulations
suggested here, so that all Americans have access to the same
information and are able to take the same precautions to safeguard their
health.
Clearly it is difficult for regulatory agencies and
courts to take much action amidst all the scientific uncertainty
surrounding cell phone radiation. Policy makers must make difficult
choices and balance conflicting interests in deciding a course of action
which adequately protects the public from potential harm, without
running the risk of driving a useful product out of the market. A
failure by regulatory agencies and courts to eff effectively act on this
unresolved issue could lead to serious, if not catastrophic,
consequences. There are over 110 million cell phone users in the United
States and industry forecasters predict that the demand for cellular
services will grow dramatically, to the point where nearly all Americans
will have a cellular phone.179 These facts drive home the point that
courts and agencies should take appropriate steps to avoid the
possibility of a public health crisis by acting aggressively now. At the
same time, there is also a danger that courts and agencies could
unnecessarily and unreasonably cause harm to the cellular
telecommunications industry, a multi-billion dollar industry that plays a
role in advancing the general welfare of citizens and business through
improved telephonic communications. Cellular technology enhances the
ability of police, fire, and other rescue personnel to provide emergency
services, increases business productivity and efficiency, and
facilitates the exchange of information. Certainly policy makers must
consider these benefits whenever they propose any regulations in this
area.
The policy recommendations proposed above
correctly balance these two competing goals of 1) informing consumers
and preventing potentially detrimental health effects, and 2) preventing
unreasonable harm to the cellular telecommunications industry. All of
the policy recommendations proposed above are relatively easy and cheap
to implement. By combining these actions, along with continued
scientific research, the FDA will be providing effective regulation in
this area of uncertainty and fear.
