The Bioinitiative Report- Chapter 4

SECTION 4:
EVIDENCE FOR INADEQUACY OF THE STANDARDS

Evidence for judging the adequacy (or inadequacy) of the existing ICNIRP and IEEE
C95.1 radiofrequency radiation standards can be taken from many relevant sources. The
ICNIRP standards are similar to the IEEE (except for the new C95.1 -2006) revisions by
IEEE SC-4), and these discussions can be used to evaluate both sets of public exposure
standards for adequacy (or inadequacy).

An important screen for assessment of how review bodies conduct their science reviews
and resulting conclusions on the adequacy of ELF and RF exposure limits depends on
embedded assumptions. The singularly most important embedded assumption is whether
these bodies assume from the beginning that only conclusive scientific evidence (proof)
will be sufficient to warrant change; or whether actions should be taken on the basis of a
growing body of evidence which provides early but consequential warning of (but not yet
proof) of possible risks.

As a result of current international research and scientific discussion on whether the
prevailing RF and ELF standards are adequate for protection of public health, there are
many recent developments to provide valuable background on the uncertainty about
whether current standards adequately protect the public.


World Health Organization Draft Framework for Electromagnetic Fields

The International EMF Project was established by WHO in 1996. Its mission was to
“pool resources and knowledge concerning the effects of exposure to EMF and make a concerted
effort to identify gaps in knowledge, recommend focused research programmes that allow better
health risk assessments to be made, conduct updated critical reviews of the scientific literature,
and work towards an international consensus and solutions on the health concerns.” (WHO
September 1996 Press Release - Welcome to the International EMF Project)

The stated role of the WHO Precautionary Framework on EMF Health Risk Research
(Radiation and Environment Health) has termed its objectives as follows;



• to anticipate and respond to possible threats before introduction of

an agent or technology


• to address public concerns that an uncertain health risk is minimized


after introduction of an agent


• to develop and select options proportional to the degree of scientific


certainty, the severity of harm, the size and nature of the affected


population and the cost.

The role of WHO is advisory only to the countries of Europe but it is an important
function and can significantly affect decision-making on public health issues. It provides
analysis and recommendations on various topics of health and environment, for
consideration by member countries of the EU. Given the EU Article 174 policy requires
a precautionary approach to judging health and environmental risks, and given that the
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charter of WHO is to serve the needs of the EU, one would think it essential that the
WHO EMF Program health criteria results should be guided by and tailored to
compliance with Article 174. This needs to occur in the assessment of the scientific
literature (e.g., not requiring studies to provide scientific proof or causal scientific
evidence but paying attention to and acting on the evidence, and the trend of the evidence
at hand) and in its environmental health criteria recommendations. If the WHO EMF
Program instead chooses to use the definitions of adverse impact and risk based on
reacting to nothing short of conclusive scientific evidence, it fails to comply with the
over-arching EU principle of health.

The World Health Organization has issued a draft framework to address the adequacy of
scientific information, and accepted definitions of bioeffect, adverse health effect and
hazard (WHO EMF Program Framework for Developing EMF Standards, Draft, October
2003). These definitions are not subject to the whim of organizations preparing public
exposure standard recommendations. The WHO definition states that:

“(A)nnoyance or discomforts caused by EMF exposure may not be pathological per se, but, if
substantiated, can affect the physical and mental well-being of a person and the resultant effect
may be considered as an adverse health effect. A health effect is thus defined as a biological
effect that is detrimental to health or well-being. According to the WHO Constitution, health is a
state of complete physical, mental, and social well-being and not merely the absence of disease or
infirmity.”

www.who.int/peh-emf


The European Union Treaties Article 174

The EU policy (Article 174-2) requires that the precautionary principle be the basis for
environmental protection for the public, and that protecting public health and taking
preventative action before certainty of harm is proven is the foundation of the
Precautionary Principle. It is directly counter to the principles used by ICNIRP and
IEEE in developing their recommendations for exposure standards. Both bodies require
proof of adverse effect and risk before amending the exposure standards; this Treaty
requires action to protect the public when a reasonable suspicion of risk exists
(precautionary action).

Article 174 (2) [ex Article 130r]

1. Community policy on the environment shall contribute to pursuit of the following
objectives:
—preserving, protecting and improving the quality of the environment;
—protecting human health;
—prudent and rational utilisation of natural resources;
—promoting measures at international level to deal with regional or worldwide
environmental problems.

2. Community policy on the environment shall aim at a high level of protection taking
into account the diversity of situations in the various regions of the Community. It shall
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be based on the precautionary principle and on the principles that preventive action
should be taken, that environmental damage should as a priority be rectified at source and
that the polluter should pay. In this context, harmonization measures answering
environmental protection requirements shall include, where appropriate, as a safeguard
clause allowing Member States to take provisional measures, for non-economic
environmental reasons, subject to a Community inspection procedure.

3. In preparing its policy on the environment, the Community shall take account of:

—available scientific and technical data;
—environmental conditions in the various regions of the Community;
—the potential benefits and costs of action or lack of action;
—the economic and social development of the Community as a whole and the balanced
development of its regions.

http://www.law.harvard.edu/library/services/research/guides/international/eu/eu_legal_research_t
reaties.php


WHO ELF Environmental Health Criteria Monograph, June 2007

In 2007. the WHO EMF Program released its ELF Health Criteria Monograph and held a
workshop in Geneva, Switzerland June 20-21st.

ELF Health Criteria Monograph

12.6 Conclusions
Acute biological effects have been established for exposure to ELF electric and magnetic fields in
the frequency range up to 100 kHz that may have adverse consequences on health. Therefore, exposure
limits are needed. International guidelines exist that have addressed this issue. Compliance with these
guidelines provides adequate protection.
Consistent epidemiological evidence suggests that chronic low-intensity ELF magnetic field
exposure is associated with an increased risk of childhood leukaemia. However, the evidence for a causal
relationship is limited, therefore exposure limits based upon epidemiological evidence are not
recommended, but some precautionary measures are warranted. (emphasis added).

The Monograph finds no reason to change the designation of EMF as a 2B (Possible)
Human Carcinogen as defined by the International Agency for Cancer Research (IARC).
In finding that ELF-EMF is classifiable as a possible carcinogen, it is inconsistent to
conclude that no change in the exposure limits is warranted. If the Monograph confirms,
as other review bodies have, that childhood leukemia occurs at least as low as the 3 mG
to 4 mG exposure range, then ICNIRP limits of 1000 mG for 50 Hz and 60 Hz ELF
exposures are clearly too high and pose a risk to the health of children.

The WHO Fact Sheet summarizes some of the Monograph findings but adds further
recommendations.

“Potential long-term effects”
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Much of the scientific research examining long-term risks from ELF magnetic field exposure has
focused on childhood leukaemia. In 2002, IARC published a monograph classifying ELF
magnetic fields as "possibly carcinogenic to humans. This classification was based on pooled
analyses of epidemiological studies demonstrating a consistent pattern of a two-fold increase in
childhood leukaemia associated with average exposure to residential power-frequency magnetic
field above 0.3 to 0.4 µT. The Task Group concluded that additional studies since then do not
alter the status of this classification.” (emphasis added)

“International exposure guidelines”

“Health effects related to short-term, high-level exposure have been established and form the
basis of two international exposure limit guidelines (ICNIRP, 1998; IEEE, 2002). At present,
these bodies consider the scientific evidence related to possible health effects from long-term,
low-level exposure to ELF fields insufficient to justify lowering these quantitative exposure
limits.”

“Regarding long-term effects, given the weakness of the evidence for a link between exposure to
ELF magnetic fields and childhood leukaemia, the benefits of exposure reduction on health are
unclear. In view of this situation, the following recommendations are given:

1) Government and industry should monitor science and promote research programmes to
further reduce the uncertainty of the scientific evidence on the health effects of ELF field
exposure. Through the ELF risk assessment process, gaps in knowledge have been identified and
these form the basis of a new research agenda.

2) Member States are encouraged to establish effective and open communication programmes
with all stakeholders to enable informed decision-making. These may include improving
coordination and consultation among industry, local government, and citizens in the planning
process for ELF EMF-emitting facilities.

3) When constructing new facilities and designing new equipment, including appliances, low-
cost ways of reducing exposures may be explored. Appropriate exposure reduction measures will
vary from one country to another. However, policies based on the adoption of arbitrary low
exposure limits are not warranted.”

The last bullet in the WHO ELF Fact Sheet does not come from the Monograph, nor is it
consistent with conclusions of the Monograph. The Monograph does call for prudent
avoidance measures, one of which could reasonably be to establish numeric planning
targets or interim limits for new and upgraded transmission lines and appliances used by
children, for example. Countries should not be dissuaded by WHO staff, who unlike the
authors of the Monograph, go too far in defining appropriate boundaries for countries that
may wish to implement prudent avoidance in ways that best suit their population needs,
expectations and resources.

www.who.int/peh-emf/project/en





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World Health Organization Report on Children’s Health and Environment

Environmental Issue Report Number 29 from the World Health Organization (2002)
cautions about the effects of radiofrequency radiation on children’s health. As part of a
publication on “Children’s Health and Environment: A Review of Evidence” the World
Health Organization (WHO) wrote:

“The possible adverse health effects in children associated with radiofrequency fields
have not been fully investigated.”

“Because there are suggestions that RF exposure may be more hazardous for the fetus
and child due to their greater susceptibility, prudent avoidance is one approach to
keeping children’s exposure as low as possible.”

“Further research is needed to clarify the potential risks of ELF-EMF and
radiofrequency fields for children’s health.”


International Agency for Research on Cancer (IARC)

A 2001 report by the WHO International Agency for Research on Cancer (IARC)
concluded that ELF-EMF power frequency fields are a Category 2B (Possible) Human
Carcinogen. These are power-frequency electromagnetic fields (50-Hz and 60-Hz
electric power frequency fields).

The World Health Organization (WHO) is conducting the International Electromagnetic
Fields (EMF) Project to assess health and environmental effects of exposure to static and
time varying electric and magnetic fields in the frequency range of 1 – 300 gigahertz
(GHz). Project goals include the development of international guidelines on exposure
limits. This work will address radio and television broadcast towers, wireless
communications transmission and telecommunications facilities, and associated devices
such as mobile phones, medical and industrial equipment, and radars. It is a multi-year
program that began in 1996 and will end in 2005. www.who.int/peh-emf


SCENIHR Opinion (European Commission Study of EMF and Human Health)

An independent Scientific Committee on newly emerging risks commissioned by the
European Union released an update of its 2001 opinion on electromagnetic fields and
human health in 2007. “The Committed addressed questions related to potential risks
associated with interaction of risk factors, synergistic effects, cumulative effects, anti-
microbial resistance, new technologies such as nanotechnologies, medical devices, tissue
engineeringm blood products, fertility reduction, cancer of endocrine organs, physical
hazards such as noise and electromagnetic fields and methodologies for assessing new
risks.” SCENIHR, 2007
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SCENIHR Conclusions on Extremely low frequency fields (ELF fields)

The previous conclusion that ELF magnetic fields are possibly carcinogenic,
chiefly based on childhood leukaemia results, is still valid. There is no generally
accepted mechanism to explain how ELF magnetic field exposure may cause
leukaemia.
For breast cancer and cardiovascular disease, recent research has indicated that an
association is unlikely. For neurodegenerative diseases and brain tumours, the link
to ELF fields remains uncertain. A relation between ELF fields and symptoms
(sometimes referred to as electromagnetic hypersensitivity) has not been
demonstrated.
SCENIHR Conclusions on Radiofrequency Radiation fields (RF fields)
Since the adoption of the 2001 opinion, extensive research has been conducted
regarding possible health effects of exposure to low intensity RF fields. This
research has investigated a variety of possible effects and has included
epidemiologic, in vivo, and in vitro research. The overall epidemiologic evidence
suggests that mobile phone use of less than 10 years does not pose any increased
risk of brain tumour or acoustic neuroma. For longer use, data are sparse, since
only some recent studies have reasonably large numbers of long-term users. Any
conclusion therefore is uncertain and tentative. From the available data, however,
it does appear that there is no increased risk for brain tumours in long-term users,
with the exception of acoustic neuroma for which there is limited evidence of a
weak association. Results of the so-called Interphone study will provide more
insight, but it cannot be ruled out that some questions will remain open.
SCENIHR Conclusions on Sensitivity of Children

Concerns about the potential vulnerability of children to RF fields have been
raised because of the potentially greater susceptibility of their developing nervous
system; in addition, their brain tissue is more conductive than that of adults since
it has a higher water content and ion concentration, RF penetration is greater
relative to head size, and they have a greater absorption of RF energy in the
tissues of the head at mobile telephone frequencies. Finally, they will have a
longer lifetime exposure.
Few relevant epidemiological or laboratory studies have addressed the possible
effects of RF field exposure on children. Owing to widespread use of mobile
phones among children and adolescents and relatively high exposures to the brain,
investigation of the potential effect of RF fields in the development of childhood
brain tumour is warranted. The characteristics of mobile phone use among
children, their potential biological vulnerability and longer lifetime exposure
make extrapolation from adult studies problematic.

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There is an ongoing debate on possible differences in RF absorption between children
and adults during mobile phone usage, e.g. due to differences in anatomy (Wiart et al.
2005, Christ and Kuster, 2005). Several scientific questions like possible differences of
the dielectric tissue parameters remain open. The anatomical development of the nervous
system is finished around 2 years of age, when children do not yet use mobile phones
although baby phones have recently been introduced. Functional development, however,
continues up to adult age and could be disturbed by RF fields.

Health Protection Agency (Formerly the NRPB - United Kingdom)

The National Radiation Protection Board or NRPB (2004) concluded, based on a review
of the scientific evidence, that the most coherent and plausible basis from which guidance
could be developed on exposures to ELF concerned weak electric field interactions in the
brain and CNS (NRPB, 2004). A cautious approach was used to indicate thresholds for
possible adverse health effects.

“Health Effects - It was concluded from the review of scientific evidence (NRPB,
2004b) that the most coherent and plausible basis from which guidance could be
developed on exposures to ELF EMFs concerned weak electric field interactions
in the brain and CNS (NRPB, 2004). A cautious approach was used to indicate
thresholds for possible adverse health effects.”

“The brain and nervous system operate using highly complex patterns of
\electrical signals. Therefore, the basic restrictions are designed to limit the
electric fields and current densities in these tissues so as to not adversely affect
their normal functioning. The adverse effects that might occur cannot easily be
characterized according to presenting signs or symptoms of disease or injury.
They represent potential changes to mental processes such as attention and
memory, as well as to regulatory functions with in the body. Thus, the basic
restrictions should not be regarded as precisely determined values below which
no adverse health effects can occur and above which clearly discernible effects
will happen. The do, however, indicate an increasing likelihood of effects
occurring as exposure increases above the basic restriction values.”

“From the results of the epidemiological investigations, there remain concerns
about a possible increased risk of child leukaemia associated with exposure to
magnetic fields above about 0.4 uT (4 mG). In this regard, it is important to
consider the possible need for further precautionary measures.”

This recent statement by the UK Health Protection Agency clearly indicates that the
current guidelines may not be protective of public health. Yet, the reference levels used
in the United Kingdom remain at 5000 mG for 50 Hz power frequency fields for
occupational exposure and 1000 mG for public exposure.



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US Government Radiofrequency Interagency Working Group Guidelines Statement

The United States Radiofrequency Interagency Working Group (RFIAWG) cited
concerns about current federal standards for public exposure to radiofrequency radiation
in 1999 (Lotz, 1999 for the Radiofrequency Interagency Working Group)

“Studies continue to be published describing biological responses to nonthermal
ELF-modulated RF radiation exposures that are not produced by CW
(unmodulated) radiation. These studies have resulted in concern that ‘exposure
guidelines based on thermal effects, and using information and concepts (time-
averaged dosimetry, uncertainty factors) that mask any differences between
intensity-modulated RF radiation exposure and CW exposure, do not directly
address public exposures, and therefore may not adequately protect the public.”

The United States government Federal Radiofrequency Interagency Working Group has
reviewed the existing ANSI/IEEE RF thermal-based exposure standard upon which the
FCC limit is based. This Working Group was made up of representatives from the US
government’s National Institute for Occupational Safety and Health (NIOSH), the
Federal Communications Commission (FCC), Occupational Health and Safety
Administration (OSHA), the Environmental Protection Agency (US EPA), the National
Telecommunication and Information Administration, and the US Food and Drug
Administration (FDA).

On June 17, 1999, the RFIAWG issued a Guidelines Statement that concluded the present
RF standard “may not adequately protect the public”. The RFIAWG identified fourteen
(14) issues that they believe are needed in the planned revisions of ANSI/IEEE RF
exposure guidelines including “to provide a strong and credible rationale to support RF
exposure guidelines”. In particular, the RFIAWG criticized the existing standards as not
taking into account chronic, as opposed to acute exposures, modulated or pulsed radiation
(digital or pulsed RF is proposed at this site), time-averaged measurements that may erase
the unique characteristics of an intensity-modulated RF radiation that may be responsible
for reported biologic effects, and stated the need for a comprehensive review
of long-term, low-level exposure studies, neurological-behavioral effects and
micronucleus assay studies (showing genetic damage from low-level RF).

The existing federal standards may not be protective of public health in critical areas.
The areas of improvement where changes are needed include: a) selection of an adverse
effect level for chronic exposures not based on tissue heating and considering modulation
effects; b) recognition of different safety criteria for acute and chronic exposures at non-
thermal or low-intensity levels; c) recognition of deficiencies in using time-averaged
measurements of RF that does not differentiate between intensity-modulated RF and
continuous wave (CW) exposure, and therefore may not adequately protect the public.

As of 2007, requests to the RFIAWG on whether these issues have been satisfactorily
resolved in the new 2006 IEEE recommendations for RF public safety limits have gone
unanswered (BioInitiative Working Group, 2007).
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United Kingdom - Parliament Independent Expert Group Report (Stewart Report)

The Parliament of the United Kingdom commissioned a scientific study group to evaluate
the evidence for RF health and public safety concerns. In May of 2000, the United
Kingdom Independent Expert Group on Mobile Phones issued a report underscoring
concern that standards are not protective of public health related to both mobile phone
use and exposure to wireless communication antennas.

Conclusions and recommendations from the Stewart Report (for Sir William Stewart)
indicated that the Group has some reservation about continued wireless technology
expansion without more consideration of planning, zoning and potential public health
concerns. Further, the Report acknowledges significant public concern over community
siting of mobile phone and other communication antennas in residential areas and near
schools and hospitals.

“Children may be more vulnerable because of their developing nervous system, the
greater absorption of energy in the tissue of the head and a longer lifetime of exposure.”

“The siting of base stations in residential areas can cause considerable concern and
distress. These include schools, residential areas and hospitals.”

“ There may be indirect health risks from living near base stations with a need for mobile
phone operators to consult the public when installing base stations.”

“Monitoring should be expecially strict near schools, and that emissions of greatest
intensity should not fall within school grounds.”

“The report recommends “a register of occupationally exposed workers be established
and that cancer risks and mortality should be examined to determine whether there are
any harmful effects.”

(IEGMP, 2000)


Food and Drug Administration (US FDA)

The Food and Drug Administration announced on March 28, 2007 it is contracting with
the National Academy of Science to conduct a symposium and issue a report on
additional research needs related to possible health effects associated with exposure to
radio frequency energy similar to those emitted by wireless communication devices. The
National Academy of Sciences will organize an open meeting of national and
international experts to discuss the research conducted to date, knowledge gaps, and
additional research needed to fill those gaps. The workshop will consider the scientific
literature and ongoing research from an international perspective in order to avoid
duplication, and in recognition of the international nature of the scientific community and
of the wireless industry.

Funding for the project will come from a Cooperative Research and Development
Agreement (CRADA) between the Food and Drug Administration's Center for Devices
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and Radiological Health and the Cellular Telecommunications and Internet Association
(CTIA).





http://www.fda.gov/cellphones/index.html



National Institutes for Health - National Toxicology Program

The National Toxicology Program (NTP) is a part of the National Institute for
Environmental Health Sciences, National Institutes for Health. Public and agency
comment has been solicited on whether to add radiofrequency radiation to its list of
substances to be tested by NTP as carcinogens. In February 2000 the FDA made a
recommendation to the NPT urging that RF be tested for carcinogenicity
(www.fda.gov.us). The recommendation is based in part on written testimony stating:

“ Animal experiments are crucial because meaningful data will not be available from
epidemiological studies for many years due to the long latency period between exposure
to a carcinogen and the diagnosis of a tumor.

“There is currently insufficient scientific basis for concluding either that wireless
communication technologies are safe or that they pose a risk to millions of users.”

“FCC radiofrequency radiation guidelines are based on protection from acute injury
from thermal effects of RF exposure and may not be protective against any non-thermal
effects of chronic exposures.”

In March of 2003, the National Toxicology Program issued a Fact Sheet regarding its
toxicology and carcinogenicity testing of radiofrequency/microwave radiation. These
studies will evaluate radiofrequency radiation in the cellular frequencies.

“The existing exposure guidelines are based on protection from acute injury from thermal
effects of RF exposure. Current data are insufficient to draw definitive conclusions
concerning the adequacy of these guidelines to be protective against any non-thermal
effects of chronic exposures. “


US Food and Drug Administration

In February of 2000, Russell D. Owen, Chief of the Radiation Biology Branch of the
Center for Devices and Radiological Health, US Food and Drug Administration (FDA)
commented that there is:

“currently insufficient scientific basis for concluding whether wireless
communication technologies pose any health risk.”

“Little is known about the possible health effects of repeated or long-term
exposures to low level RF of the sort emitted by such devices.”

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