Wednesday, September 12, 2018

ICNIRP’s Exposure Guidelines for Radio Frequency Fields

US Scientist Criticizes ICNIRP’s Refusal to Reassess Cell Phone Radiation Exposure Guidelines 
after US National Toxicology Program Studies Show Clear Evidence of Cancer 

Ronald L. Melnick, Ph.D., has issued a scientific critique of ICNIRPs dismissal of the cell phone radiation studies conducted by the U.S. National Toxicology Program (NTP).

On September 4, 2018, ICNIRP issued a “Note on Recent Animal Studies” that concluded the $28 million NTP study did “not provide a reliable basis” for changing the over two decades old guidelines on radio frequency- cell phone and wireless – radiation. 

In response, Dr. Melnick addressed 15 concerns raised by the ICNIRP about the NTP studies. He presented data to show that the ICNIRP document contains “numerous false and misleading statements" and concluded by questioning who the ICNIRP is protecting:
"Based on numerous incorrect and misleading claims, the ICNIRP report concludes that “these studies (NTP and Ramazzini) do not provide a reliable basis for revising the existing radiofrequency exposure guidelines.” The data on gliomas of the brain and schwannomas of the heart induced by cell phone radiation are suitable for conducting a quantitative risk assessment and subsequent re-evaluation of health-based exposure limits. The ‘P’ in ICNIRP stands for Protection. One must wonder who this commission is trying to protect – evidently, it is not public health."
Dr. Melnick was a Senior Scientist in the National Toxicology Program, National Institute of Environmental Health Sciences, National Institutes of Health. He served as a toxicologist for over 28 years before retiring in 2009. In 2007 he received the American Public Health Association’s David P. Rall Award for science-based advocacy in public health.




Melnick RL. Critique of the ICNIRP Note of September 4, 2018 Regarding Recent Animal Carcinogenesis Studies. Environmental Health Trust. Sep 12, 2018. Open access document: http://bit.ly/MelnickICNIRP9-12-2018

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Comments about the ICNIRP evaluation of the NTP and Ramazzini Institute studies 
by the Ramazzini Institute 

In recent days, the International Commission for the Protection of Non-Ionizing Radiation (ICNIRP) has dismissed the results of the studies conducted by the Ramazzini Institute (RI) and the National Toxicology Program (NTP) on cell phone radiation as "unconvincing
Following are the observations of Dr. Fiorella Belpoggi, director of the "Cesare Maltoni" cancer research center of the Ramazzini Institute.



1. Both the NTP and the RI studies were well performed,and no bias affected the results. The ICNIRP confirms this conclusion.
2. Schwannomas are tumors arising from the Schwann cells. They are peripheral glial cells which cover and protect the surface of all nerves diffused throughout the body; so vestibular (acoustic nerve) and heart schwannomas have the same tissue of origin: ICNIRP seems to ignore that.
3. In rats, increases in malignant heart schwannomas, malignant glial tumors of the brain and Schwann Cell Hyperplasia (a pre-malignant lesion) are rare yet these lesions were observed in exposed animals in both laboratories, at thousands of kilometers distance, in a wide range of radiofrequency radiation exposures studied. These findings could not be interpreted as occurring “by chance”.
4. We are scientists. Our role is to produce solid evidence for hazard and risk assessment. Underestimating the evidence from carcinogen bioassays and delays in regulation have already proven many times to have severe consequences, as in the case of asbestos, smoking and vinyl chloride. This position of ICNIRP represents its own responsibility toward citizens and public health.
5. ICNIRP is not a public health agency that routinely evaluates carcinogens. On the other hand, an independent agency that has evaluated over 1000 agents, IARC, as early as 2011 classified radio freqency radiation as a possible carcinogen on the basis of limited evidence in humans and limited evidence in animals. The studies of the RI and NTP will certainly contribute to the burden of evidence that IARC and other public health agencies can draw upon as a solid base for the re-evaluation of RFR carcinogenicity.
http://bit.ly/RI-ICNIRP

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ICNIRP Critique of the National Toxicology Program and Ramazzini Institute
Animal Studies of the Carcinogenicity of Long-Term Exposure to Cell Phone Radiation

ICNIRP. ICNIRP Note on Recent Animal Carcinogenesis Studies. Munich, Germany. Sep 4, 2018. https://www.icnirp.org/cms/upload/publications/ICNIRPnote2018.pdf

Introduction

Two recent animal studies investigating the carcinogenic potential of long-term exposure to
radiofrequency electromagnetic fields (EMFs) associated with mobile phones have been released: one by the U.S. National Toxicology Program (NTP 2018a, b) and the other from the Ramazzini Institute (Falcioni et al. 2018). These studies, among others, have been taken into account during revision of the ICNIRP radiofrequency exposure guidelines. However, both studies have inconsistencies and limitations that affect the usefulness of their results for setting exposure guidelines, and both need to be considered within the context of other animal and human carcinogenicity research. Overall, based on the considerations outlined below, ICNIRP concludes that these studies do not provide a reliable basis for revising the existing radiofrequency exposure guidelines.

<snip>

Conclusion

Although the NTP (2018a, b) and Falcioni et al. (2018) studies used large numbers of animals, best laboratory practice, and exposed animals for the whole of their lives, consideration of their findings does not provide evidence that radiofrequency EMF is carcinogenic. NTP reported that their strongest findings were of increased malignant cardiac schwannoma in male rats, however that is not consistent with the results of Falcioni et al. (2018), is not consistent with the NTP female rat nor male or female mouse results, and is not consistent with the radiofrequency EMF cancer literature more generally. While results from epidemiological studies suggest vestibular schwannoma is an outcome of interest,

this is not true for malignant cardiac schwannoma. NTP found no increase in schwannoma overall or for vestibular schwannoma. Further, as multiple comparisons were not controlled for in the NTP study, there is no indication that the increased incidence of malignant cardiac schwannomas in male rats was more than what would be expected by chance alone. ICNIRP considers that the NTP (2018a, b) and Falcioni et al. (2018) studies do not provide a consistent, reliable and generalizable body of evidence that can be used as a basis for revising current human exposure guidelines. Further research is required that addresses the above limitations.

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Jul 23, 2018


ICNIRP requests public input on its radio frequency radiation exposure guidelines

The International Commission on Non-Ionizing Radiation Protection (ICNIRP) has recently announced that it wants public input regarding a new draft of its guidelines on limiting radio frequency (RF) fields (i.e., electromagnetic fields [EMF] from 100 kilohertz to 300 Gigahertz).

“The main objective of this publication is to establish guidelines for limiting exposure to EMFs that will provide a high level of protection for all people against known adverse health effects from direct, non-medical exposures to both short- and long-term, continuous and discontinuous radiofrequency EMFs.”

The new publication replaces the 1998 RF exposure guidelines which have influenced RF exposure standards in many nations including the guidelines adopted by the U.S. Federal Communications Commission.

ICNIRP is an association with a scientific mission that is registered in Germany as a nonprofit organization. It is “formally recognized as an official collaborating non-governmental organization (NGO) by the World Health Organization (WHO) and the International Labour Organization (ILO). ICNIRP is linked to many organizations engaged in non-ionizing radiation protection worldwide and consults with the European Commission.”

ICNIRP’s new draft safety guidelines dismiss the research on the effects of chronic exposure to non-thermal levels of RF radiation. In its latest health risk assessment, ICNIRP concludes that there are no “substantiated” adverse effects of RF radiation on human health. See Appendix B: Health Risk Assessment Literature and a summary of the findings which appears below.

Following is ICNIRP’s justification for ignoring most of the EMF research in its health risk assessment:

"ICNIRP bases its guidelines on substantiated adverse health effects. This makes the difference between a biological and an adverse health effect an important distinction, where only adverse health effects require limits for the protection of humans." (ICNIRP Guidelines: Guidelines for Limiting Exposure to Time-Varying Electric, Magnetic and Electromagnetic Fields [100 kHz TO 300 GHz]. July 11, 2018 draft. p. 2)

“These guidelines specify quantitative EMF levels for safe personal exposure. Adherence to these levels is intended to protect people from all known harmful effects of radiofrequency EMF exposure. To determine these levels, ICNIRP first identified published scientific literature concerning effects of radiofrequency EMF exposure on biological systems, and established which of these were both harmful to human health, and scientifically substantiated. This latter point is important because ICNIRP considers that, in general, reported effects need to be independently replicated, be of sufficient scientific quality and explicable more generally within the context of the scientific literature, in order to be taken as ‘evidence’ and used for setting exposure restrictions. Within the guidelines, ‘evidence’ will be used within this context, and ‘substantiated effect’ used to describe reported effects that satisfy this definition of evidence. (ICNIRP Guidelines: Guidelines for Limiting Exposure to Time-Varying Electric, Magnetic and Electromagnetic Fields [100 kHz TO 300 GHz].”  July 11, 2018 draft. p. 2)

Public consultation on ICNIRP RF exposure guidelines

If you choose to provide public input to ICNIRP, the draft documents consist of RFexposure guidelines and two appendices. Appendix A reviews dosimetry, and Appendix B summarizes the health risk assessment.

The consultation process which began on July 11 ends on October 9, 2018. ICNIRP members will review public comments prior to finalizing the RF exposure guidelines. ICNIRP will not reply to comments.

To provide comments on the draft documents, complete the form on the ICNIRP website or the template available at https://www.icnirp.org/en/activities/public-consultation/consultation-1.html

Files for download



My editorial comments

To date, 242 scientists who have published peer-reviewed research on EMF and biology or health have signed the EMF Scientist Appeal. Collectively, these scientists from 41 nations have published more than 2,000 papers on EMF. The Appeal calls on the WHO and the United Nations including its member states to adopt more protective exposure guidelines for EMF including RF radiation in the face of increasing evidence of health risks since these exposures are a rapidly growing form of worldwide environmental pollution.

In a recently published, peer-reviewed paper, “Thermal and non-thermal health effects of low intensity non-ionizing radiation: An international perspective,Belpomme and his colleagues (2018) criticize the WHO due to its reliance upon ICNIRP and its members for expert advice. The paper claims that ICNIRP and its advisors have “close associations with industry,” and “conflicts of interest.” According to the authors, ICNIRP and its advisors have been engaged in decades of “denial of serious non-thermal effects of RF-EMFs in spite of overwhelming scientific evidence to the contrary.” 

Moreover, Belpomme and his colleagues criticize ICNIRP’s safety limits:

“The specific absorption rate (SAR)-based ICNIRP safety limits were established on the basis of simulation of EMF energy absorption using standardized adult male phantoms, and designed to protect people only from the thermal effects of EMFs. These assumptions are not valid for two reasons. Not only do they fail to consider the specific morphological and bioclinical vulnerabilities of children, but also they ignore the effects known to occur at non-thermal intensities….”

Finally, Belpomme and his colleagues (2018) provide a summary of the peer-reviewed scientific literature that arrives at very different conclusions than ICNIRP's health risk assessment:
"It is urgent that national and international bodies, particularly the WHO, take this significant public health hazard seriously and make appropriate recommendations for protective measures to reduce exposures. This is especially urgently needed for children and adolescents. It is also important that all parts of society, especially the medical community, educators, and the general public, become informed about the hazards associated with exposure to EMFs and of the steps that can be easily taken to reduce exposure and risk of associated disease."

The rules that ICNIRP applies for a study to be included in its health risk assessment seem overly stringent. If other official bodies (e.g., the International Agency for Research on Cancer or the U.S. Environmental Protection Agency) were to adopt such rules, I suspect that very few chemicals would be classified as toxins or carcinogens. By its own admission, ICNIRP is not concerned about protecting animal or plant life from the adverse effects of EMF exposure, and it is arguable that they are truly concerned about protecting humans.

If the claims of some EMF scientists and scientific organizations (e.g., the European Cancer and Environment Research Institute and the Russian National Committee on Non-Ionizing Radiation Protection) are true that ICNIRP’s members and scientific advisors are selected because they are biased toward industry, then it is fruitless to engage in ICNIRP’s public consultation process (see my posts from May 1 through June 27, 2017.)

Since the credibility of ICNIRP depends heavily upon its association with the WHO, a more fruitful activity for the EMF scientific community might be to convince the WHO and governments not to rely on ICNIRP for EMF guidelines and no longer consult ICNIRP’s advisors.

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Summaries from ICNIRP’s Draft Appendix B: Health Risk Assessment Literature


“ICNIRP bases its guidelines on substantiated adverse health effects. This makes the difference between a biological and an adverse health effect an important distinction, where only adverse health effects require limits for the protection of humans.” (p. 2)

Brain electrical activity and cognitive function

“In summary, there is no substantiated experimental or epidemiological evidence that exposure to radiofrequency EMF affects higher cognitive functions relevant to health.” (p. 3)

Symptoms and wellbeing

“In summary, no reports of adverse effects on symptoms and wellbeing have been substantiated, except for pain, which is related to elevated temperature at high exposure levels. Thresholds for these have not been clearly identified, but the best estimate is within the vicinity of 10 and 20 mA for indirect contact currents, for children and adults respectively, and 12.5 kW m-2 for  direct millimeter-wave exposure.”  (pp. 3-4)

Other brain physiology and related functions

“In summary, there is no evidence of effects of radiofrequency EMF on physiological processes or eye pathology that impair health in humans. Some evidence of superficial eye damage has been shown in rabbits at exposures of at least 1.4 kW m-2, although the relevance of this to humans has not been demonstrated.“ (p. 4)

Auditory, vestibular and ocular function

“In summary, no effects on auditory, vestibular, or ocular function relevant to human health have been substantiated.” (p. 5)

Neuroendocrine system

“In summary, the lowest level at which an effect of radiofrequency EMF on the neuroendocrine system has been observed is 4 W kg-1 (in rodents and primates), but there is no evidence that this translates to humans or is relevant to human health. No other effects have been substantiated.” (p. 6)

Neurodegenerative diseases

 “In summary, no adverse effects on neurodegenerative diseases have been substantiated.” (p. 6)

Cardiovascular system, autonomic nervous system and thermoregulation

“In summary, no effects on the cardiovascular system, autonomic nervous system, or thermoregulation that compromise health have been substantiated for exposures with whole body average SARs below approximately 1 W kg-1, and there is some evidence that 4 W kg-1 is not sufficient to alter body core temperature in hamsters. However, there is strong evidence that whole body exposures in rats that are sufficient to increase body core temperature by several degrees centigrade can cause serious adverse health effects in rats.” (p. 7)

Immune system and haematology

“The few human studies have not indicated any evidence that radiofrequency EMF affects health in humans via the immune system or haematology.” (p. 7)

Fertility, reproduction and childhood development

“In summary, no adverse effects of radiofrequency EMF exposure on fertility, reproduction or development relevant to human health have been substantiated.” (p. 8)

Cancer    

“In summary, no effects of radiofrequency EMF on cancer have been substantiated.” (pp. 8-9)