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Regarding ICNIRP'S Evaluation of the National Toxicology Program's Carcinogenicity Studies on Radiofrequency Electromagnetic Fields

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... Among the principal critiques of the NTP study are those from the anonymous FDA report (FDA U.S, 2020) and the International Commission on Non Ionizing Radiation Protection (ICNIRP) (Protection (ICNIRP)1, 2020), both of which were disputed in considerable detail (Melnick, 2019(Melnick, , 2020. It must be noted that the NTP study was commissioned by the FDA at the behest of the FCC (Federal Communications Commission), reviewed, and approved by them (Melnick, 2019). ...
... It was specifically designed to test the null hypothesis that cell phone radiation at non-thermal exposure intensities could not cause adverse health effects. By the definition of the FCC and ICNIRP "non-thermal" exposure intensities means that there is no more than a 1 • rise in core body temperature resulting from acute exposures (Melnick, 2020;"OET -Bulletin No. 65 (August 1997)," 2011). The NTP carried out initial studies to find the exposure limit for rats and mice in terms of SAR to maintain this limit and found that the maximum whole body exposure for such would be a SAR value of 6 W/kg (M. ...
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In an effort to clarify the nature of causal evidence regarding the potential impacts of RFR on biological systems, this paper relies on a well-established framework for considering causation expanded from that of Bradford Hill, that combines experimental and epidemiological evidence on carcinogenesis of RFR. The Precautionary Principle, while not perfect, has been the effective lodestone for establishing public policy to guard the safety of the general public from potentially harmful materials, practices or technologies. Yet, when considering the exposure of the public to anthropogenic electromagnetic fields, especially those arising from mobile communications and their infrastructure, it seems to be ignored. The current exposure standards recommended by the Federal Communications Commission (FCC) and International Commission on Non-Ionizing Radiation Protection (ICNIRP) consider only thermal effects (tissue heating) as potentially harmful. However, there is mounting evidence of non-thermal effects of exposure to electromagnetic radiation in biological systems and human populations. We review the latest literature on in vitro and in vivo studies, on clinical studies on electromagnetic hypersensitivity, as well as the epidemiological evidence for cancer due to the action of mobile based radiation exposure. We question whether the current regulatory atmosphere truly serves the public good when considered in terms of the Precautionary Principle and the principles for deducing causation established by Bradford Hill. We conclude that there is substantial scientific evidence that RFR causes cancer, endocrinological, neurological and other adverse health effects. In light of this evidence the primary mission of public bodies, such as the FCC to protect public health has not been fulfilled. Rather, we find that industry convenience is being prioritized and thereby subjecting the public to avoidable risks.
... ICNIRP [23] dismissed the evidence of carcinogenicity for RFR that was provided in the studies by the NTP [18] and the Ramazzini Institute [22] based on their earlier critique of those studies [24]. However, that critique demonstrated an unfortunate lack of understanding together with a misrepresentation of the design, conduct, and interpretation of experimental carcinogenicity studies in animal models [25], as well as a lack of appreciation for the remarkable concordance between the tumor responses observed in experimental animals with those identified in cancer epidemiology studies of mobile phone users described under Assumption #6. ...
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In the late-1990s, the FCC and ICNIRP adopted radiofrequency radiation (RFR) exposure limits to protect the public and workers from adverse effects of RFR. These limits were based on results from behavioral studies conducted in the 1980s involving 40–60-minute exposures in 5 monkeys and 8 rats, and then applying arbitrary safety factors to an apparent threshold specific absorption rate (SAR) of 4 W/kg. The limits were also based on two major assumptions: any biological effects were due to excessive tissue heating and no effects would occur below the putative threshold SAR, as well as twelve assumptions that were not specified by either the FCC or ICNIRP. In this paper, we show how the past 25 years of extensive research on RFR demonstrates that the assumptions underlying the FCC’s and ICNIRP’s exposure limits are invalid and continue to present a public health harm. Adverse effects observed at exposures below the assumed threshold SAR include non-thermal induction of reactive oxygen species, DNA damage, cardiomyopathy, carcinogenicity, sperm damage, and neurological effects, including electromagnetic hypersensitivity. Also, multiple human studies have found statistically significant associations between RFR exposure and increased brain and thyroid cancer risk. Yet, in 2020, and in light of the body of evidence reviewed in this article, the FCC and ICNIRP reaffirmed the same limits that were established in the 1990s. Consequently, these exposure limits, which are based on false suppositions, do not adequately protect workers, children, hypersensitive individuals, and the general population from short-term or long-term RFR exposures. Thus, urgently needed are health protective exposure limits for humans and the environment. These limits must be based on scientific evidence rather than on erroneous assumptions, especially given the increasing worldwide exposures of people and the environment to RFR, including novel forms of radiation from 5G telecommunications for which there are no adequate health effects studies.
... Finally, the methodology used for the development of health-based exposure limits, such as the benchmark dose modeling and the application of safety factors, remains an evolving area of research in risk assessment. The lack of information about the shape of the doseresponse curve below the lowest dose tested and the decreased incidence of various lesions observed at the highest dose tested by the NTP [42,60,61] pose questions for future research. The point of departure selected from benchmark modeling presented here, BMDL 10 value of 0.2-0.4 ...
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Background Epidemiological studies and research on laboratory animals link radiofrequency radiation (RFR) with impacts on the heart, brain, and other organs. Data from the large-scale animal studies conducted by the U.S. National Toxicology Program (NTP) and the Ramazzini Institute support the need for updated health-based guidelines for general population RFR exposure. Objectives The development of RFR exposure limits expressed in whole-body Specific Absorption Rate (SAR), a metric of RFR energy absorbed by biological tissues. Methods Using frequentist and Bayesian averaging modeling of non-neoplastic lesion incidence data from the NTP study, we calculated the benchmark doses (BMD) that elicited a 10% response above background (BMD 10 ) and the lower confidence limits on the BMD at 10% extra risk (BMDL 10 ). Incidence data for individual neoplasms and combined tumor incidence were modeled for 5% and 10% response above background. Results Cardiomyopathy and increased risk of neoplasms in male rats were the most sensitive health outcomes following RFR exposures at 900 MHz frequency with Code Division Multiple Access (CDMA) and Global System for Mobile Communications (GSM) modulations. BMDL 10 for all sites cardiomyopathy in male rats following 19 weeks of exposure, calculated with Bayesian model averaging, corresponded to 0.27–0.42 W/kg whole-body SAR for CDMA and 0.20–0.29 W/kg for GSM modulation. BMDL 10 for right ventricle cardiomyopathy in female rats following 2 years of exposure corresponded to 2.7–5.16 W/kg whole-body SAR for CDMA and 1.91–2.18 W/kg for GSM modulation. For multi-site tumor modeling using the multistage cancer model with a 5% extra risk, BMDL 5 in male rats corresponded to 0.31 W/kg for CDMA and 0.21 W/kg for GSM modulation. Conclusion BMDL 10 range of 0.2—0.4 W/kg for all sites cardiomyopathy in male rats was selected as a point of departure. Applying two ten-fold safety factors for interspecies and intraspecies variability, we derived a whole-body SAR limit of 2 to 4 mW/kg, an exposure level that is 20–40-fold lower than the legally permissible level of 0.08 W/kg for whole-body SAR under the current U.S. regulations. Use of an additional ten-fold children’s health safety factor points to a whole-body SAR limit of 0.2–0.4 mW/kg for young children.
... ICNIRP claims that the animal studies "do not provide evidence that radiofrequency EMFs are carcinogenic," while an independent peer review of the NTP data concluded that this study provided 'clear evidence of carcinogenic activity', see Program studies on cell phone radiation" [114]. This included misleading statements by ICNIRP on e.g., the pathology review procedure, rat survival rates, multiple comparisons, but also excluding discussion of other end points such as DNA strand breaks in the brain cells, and increased incidence of cardiomyopathy. ...
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Children today are conceived and live in a sea of wireless radiation that did not exist when their parents were born. The launch of the digital age continues to transform the capacity to respond to emergencies and extend global communications. At the same time that this increasingly ubiquitous technology continues to alter the nature of commerce, medicine, transport and modern life overall, its varied and changing forms have not been evaluated for their biological or environmental impacts. Standards for evaluating radiation from numerous wireless devices were first set in 1996 to avoid heating tissue and remain unchanged since then in the U.S. and many other nations. A wide range of evidence indicates that there are numerous non-thermal effects from wireless radiation on reproduction, development, and chronic illness. Many widely used devices such as phones and tablets function as two-way microwave radios, sending and receiving various frequencies of information-carrying microwave radiation on multiple simultaneously operating antennas. Expert groups advising governments on this matter do not agree on the best approaches to be taken. The American Academy of Pediatrics recommends limited screen time for children under the age of two, but more than half of all toddlers regularly have contact with screens, often without parental engagement. Young children of parents who frequently use devices as a form of childcare can experience delays in speech acquisition and bonding, while older children report feelings of disappointment due to 'technoference'-parental distraction due to technology. Children who begin using devices early in life can become socially, psychologically and physically addicted to the technology and experience withdrawal upon cessation. We review relevant experimental, epidemiological and clinical evidence on biological and other impacts of currently used wireless technology, including advice to include key questions at pediatric wellness checkups from infancy to young adulthood. We conclude that consistent with advice in pediatric radiology, an approach that recommends that microwave radiation exposures be As Low As Reasonably Achievable (ALARA) seems sensible and prudent, and that an independently-funded training, research and monitoring program should be carried out on the long term physical and psychological impacts of rapidly changing technological milieu, including ways to mitigate impacts through modifications in hardware and software. Current knowledge of electrohypersensitivity indicates the importance of reducing wireless exposures especially in schools and health care settings.
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Due to the continuous rising ambient levels of nonionizing electromagnetic fields (EMFs) used in modern societies-primarily from wireless technologies-that have now become a ubiquitous biologically active environmental pollutant, a new vision on how to regulate such exposures for non-human species at the ecosystem level is needed. Government standards adopted for human exposures are examined for applicability to wildlife. Existing environmental laws, such as the National Environmental Policy Act and the Migratory Bird Treaty Act in the U.S. and others used in Canada and throughout Europe, should be strengthened and enforced. New laws should be written to accommodate the ever-increasing EMF exposures. Radiofrequency radiation exposure standards that have been adopted by worldwide agencies and governments warrant more stringent controls given the new and unusual signaling characteristics used in 5G technology. No such standards take wildlife into consideration. Many species of flora and fauna, because of distinctive physiologies, have been found sensitive to exogenous EMF in ways that surpass human reactivity. Such exposures may now be capable of affecting endogenous bioelectric states in some species. Numerous studies across all frequencies and taxa indicate that low-level EMF exposures have numerous adverse effects, including on orientation, migration, food finding, reproduction, mating, nest and den building, territorial maintenance, defense, vitality, longevity, and survivorship. Cyto- and geno-toxic effects have long been observed. It is time to recognize ambient EMF as a novel form of pollution and develop rules at regulatory agencies that designate air as 'habitat' so EMF can be regulated like other pollutants. Wildlife loss is often unseen and undocumented until tipping points are reached. A robust dialog regarding technology's high-impact role in the nascent field of electroecology needs to commence. Long-term chronic low-level EMF exposure standards should be set accordingly for wildlife, including, but not limited to, the redesign of wireless devices, as well as infrastructure, in order to reduce the rising ambient levels (explored in Part 1). Possible environmental approaches are discussed. This is Part 3 of a three-part series.
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We performed a case-control study on the use of cellular and cordless telephones and the risk for brain tumors. We report the results for benign brain tumors with data from 413 cases (89% response rate), 305 with meningioma, 84 with acoustic neuroma, 24 with other types and 692 controls (84% response rate). For meningioma, analogue phones yielded odds ratio (OR) = 1.7, 95% confidence interval (CI) = 0.97-3.0, increasing to OR = 2.1, 95% CI = 1.1-4.3 with a >10-year latency period. Also digital cellular phones and cordless phones increased the risk to some extent. For acoustic neuroma, analogue phones gave OR = 4.2, 95% CI = 1.8-10 increasing to OR = 8.4, 95% CI = 1.6-45 with a >15-year latency period, but based on low numbers. Digital phones yielded OR = 2.0, 95% CI = 1.05-3.8, whereas for cordless phones OR was not significantly increased. In the multivariate analysis, analogue phones represented a significant risk factor for acoustic neuroma.
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Most media accounts of the U.S. National Toxicology Program's (NTP's) final report have understandably focused on the statistically significant finding of "clear evidence" that both GSM and code-division multiple access (CDMA)-modulated 900-MHz wireless RF radiation led to the development of malignant schwannoma, a rare form of tumor, in the hearts of male rats. In addition to this, unusual patterns of cardiomyopathy, i.e., damage to heart tissue, were observed in both RF-exposed male and female Sprague-Dawley rats compared with concurrent control animals, although the findings for female rats were deemed as providing only uncertain or "equivocal" evidence for schwannomas and malignant gliomas, compared to concurrent controls.
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The National Toxicology Program (NTP) conducted two-year studies of cell phone radiation in rats and mice exposed to CDMA- or GSM-modulated radiofrequency radiation (RFR) at exposure intensities in the brain of rats that were similar to or only slightly higher than potential, localized human exposures from cell phones held next to the head. This study was designed to test the (null) hypothesis that cell phone radiation at non-thermal exposure intensities could not cause adverse health effects, and to provide dose-response data for any detected toxic or carcinogenic effects. Partial findings released from that study showed significantly increased incidences and/or trends for gliomas and glial cell hyperplasias in the brain and schwannomas and Schwann cell hyperplasias in the heart of exposed male rats. These results, as well as the findings of significantly increased DNA damage (strand breaks) in the brains of exposed rats and mice, reduced pup birth weights when pregnant dams were exposed to GSM- or CDMA-modulated RFR, and the induction of cardiomyopathy of the right ventricle in male and female rats clearly demonstrate that the null hypothesis has been disproved. The NTP findings are most important because the International Agency for Research on Cancer (IARC) classified RFR as a "possible human carcinogen" based largely on increased risks of gliomas and acoustic neuromas (which are Schwann cell tumors on the acoustic nerve) among long term users of cell phones. The concordance between rats and humans in cell type affected by RFR strengthens the animal-to-human association. This commentary addresses several unfounded criticisms about the design and results of the NTP study that have been promoted to minimize the utility of the experimental data on RFR for assessing human health risks. In contrast to those criticisms, an expert peer-review panel recently concluded that the NTP studies were well designed, and that the results demonstrated that both GSM- and CDMA-modulated RFR were carcinogenic to the heart (schwannomas) and brain (gliomas) of male rats.
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It is proposed that radical concentrations can be modified by combinations of weak, steady and alternating magnetic fields that modify the population distribution of the nuclear and electronic spin state, the energy levels and the alignment of the magnetic moments of the components of the radical pairs. In low external magnetic fields, the electronic and nuclear angular momentum vectors are coupled by internal forces that outweigh the external fields' interactions and are characterized in the Hamiltonian by the total quantum number F. Radical pairs form with their unpaired electrons in singlet (S) or triplet (T) states with respect to each other. At frequencies corresponding to the energy separation between the various states in the external magnetic fields, transitions can occur that change the populations of both electron and nuclear states. In addition, the coupling between the nuclei, nuclei and electrons, and Zeeman shifts in the electron and nuclear energy levels can lead to transitions with resonances spanning frequencies from a few Hertz into the megahertz region. For nuclear energy levels with narrow absorption line widths, this can lead to amplitude and frequency windows. Changes in the pair recombination rates can change radical concentrations and modify biological processes. The overall conclusion is that the application of magnetic fields at frequencies ranging from a few Hertz to microwaves at the absorption frequencies observed in electron and nuclear resonance spectroscopy for radicals can lead to changes in free radical concentrations and have the potential to lead to biologically significant changes. Bioelectromagnetics. 2014;9999:1–10. © 2014 Wiley Periodicals, Inc.
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Methods An interview-based case-control study with 2708 glioma and 2409 meningioma cases and matched controls was conducted in 13 countries using a common protocol. Results A reduced odds ratio (OR) related to ever having been a regular mobile phone user was seen for glioma [OR 0.81; 95% confidence interval (CI) 0.70-0.94] and meningioma (OR 0.79; 95% CI 0.68-0.91), possibly reflecting participation bias or other methodological limitations. No elevated OR was observed >= 10 years after first phone use (glioma: OR 0.98; 95% CI 0.76-1.26; meningioma: OR 0.83; 95% CI 0.61-1.14). ORs were = 1640 h, the OR was 1.40 (95% CI 1.03-1.89) for glioma, and 1.15 (95% CI 0.81-1.62) for meningioma; but there are implausible values of reported use in this group. ORs for glioma tended to be greater in the temporal lobe than in other lobes of the brain, but the CIs around the lobe-specific estimates were wide. ORs for glioma tended to be greater in subjects who reported usual phone use on the same side of the head as their tumour than on the opposite side. Conclusions Overall, no increase in risk of glioma or meningioma was observed with use of mobile phones. There were suggestions of an increased risk of glioma at the highest exposure levels, but biases and error prevent a causal interpretation. The possible effects of long-term heavy use of mobile phones require further investigation.
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The International Agency for Research on Cancer (IARC) at WHO evaluation of the carcinogenic effect of RF-EMF on humans took place during a 24-31 May 2011 meeting at Lyon in France. The Working Group consisted of 30 scientists and categorised the radiofrequency electromagnetic fields from mobile phones, and from other devices that emit similar non-ionising electromagnetic fields (RF-EMF), as Group 2B, i.e., a 'possible', human carcinogen. The decision on mobile phones was based mainly on the Hardell group of studies from Sweden and the IARC Interphone study. We give an overview of current epidemiological evidence for an increased risk for brain tumours including a meta-analysis of the Hardell group and Interphone results for mobile phone use. Results for cordless phones are lacking in Interphone. The meta-analysis gave for glioma in the most exposed part of the brain, the temporal lobe, odds ratio (OR)=1.71, 95% confidence interval (CI)=1.04-2.81 in the ≥10 years (>10 years in the Hardell group) latency group. Ipsilateral mobile phone use ≥1640h in total gave OR=2.29, 95% CI=1.56-3.37. The results for meningioma were OR=1.25, 95% CI=0.31-4.98 and OR=1.35, 95% CI=0.81-2.23, respectively. Regarding acoustic neuroma ipsilateral mobile phone use in the latency group ≥10 years gave OR=1.81, 95% CI=0.73-4.45. For ipsilateral cumulative use ≥1640h OR=2.55, 95% CI=1.50-4.40 was obtained. Also use of cordless phones increased the risk for glioma and acoustic neuroma in the Hardell group studies. Survival of patients with glioma was analysed in the Hardell group studies yielding in the >10 years latency period hazard ratio (HR)=1.2, 95% CI=1.002-1.5 for use of wireless phones. This increased HR was based on results for astrocytoma WHO grade IV (glioblastoma multiforme). Decreased HR was found for low-grade astrocytoma, WHO grades I-II, which might be caused by RF-EMF exposure leading to tumour-associated symptoms and earlier detection and surgery with better prognosis. Some studies show increasing incidence of brain tumours whereas other studies do not. It is concluded that one should be careful using incidence data to dismiss results in analytical epidemiology. The IARC carcinogenic classification does not seem to have had any significant impact on governments' perceptions of their responsibilities to protect public health from this widespread source of radiation.
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In a series of experiments, Klebsiella pneumoniae was inoculated intratracheally into rats and mice, and the temperature of the animals was recorded twice daily using microchip transponders. Transponders are interrogated by radio frequencies and were implanted either subcutaneously or intraperitoneally. The microchip temperatures were compared with rectal temperatures taken at the same time. The purpose of the experiments was (a) to investigate the practicability and reliability of the ELAMS for temperature recording; (b) to compare values given by subcutaneously or intraperitoneally implanted transponders with rectal temperatures; and (c) to determine a 'temperature-cut-off point' as an alternative for 'death of the animal' as an end point for the experiment. The results showed that the ELAMS was easy to operate and no important drawbacks in the use of the system were observed. The temperatures generated by the transponders implanted subcutaneously and intraperitoneally did not differ significantly from rectal temperatures. In two out of three experiments on rats, it was shown that when the temperatures reached values below 36 degrees C, the median survival time of the animals was 24 h. In the one experiment on mice the same median survival time was observed at 36 degrees C. In one experiment using rats, however, the disease was so acute that death occurred before any temperature drop was seen. The results show that when a 36 degrees C cut-off point is used instead of the time of death in this particular animal model, the statistical analysis was not altered, but that it would spare animals further suffering for approximately 24 h. The argument that measuring body temperature is a laborious job and stressful to the animals is overcome when the ELAMS system is used.
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