ICNIRP’s Exposure Guidelines for Radio Frequency Fields
August 28, 2018 (Updated August 29)
The publication of this article now is especially relevant because the International Commission on Non-Ionizing Radiation Protection (ICNIRP) is in the process of updating its RF radiation exposure guidelines. ICNIRP plans to reaffirm its obsolete guidelines based upon the Commission's long-standing position that exposure to non-thermal levels of RF radiation does not pose any health risks. Dr. Lin served as an ICNIRP Commissioner from 2004-2016 and chaired ICNIRP's Standing Committee on Physics and Engineering from 2008-2012.
Following are key passages from Dr. Lin’s paper (1):
“On 28 March 2018, following a thorough review of the draft NTP reports, pathologists and toxicologists on the peer-review panel concluded that, among other observations, there was statistically significant and “clear evidence” that both GSM- and CDMA-modulated RF radiation had led to the development of malignant schwannoma (a rare form of tumor) in the heart of male rats (of the Harlan-Sprague-Dawley strain). Further, there was “equivocal evidence” for the same schwannoma risk among female rats.
The panel also noted that there were unusual patterns of cardiomyopathy, or damage to heart tissue, in both RF-exposed male and female rats when compared with concurrent control animals. In addition, based on statistical significance, the panel concluded that the pathology findings showed indications of “some evidence” for RF-dependent carcinogenic activity in the brain of male rats, specifically glioma. However, the findings for female rats were deemed as providing only “equivocal evidence” for malignant gliomas when compared with concurrent controls.” (pp. 16-17)
“The NTP cell-phone RF exposure study is, by far, the largest study of its kind . It was expensive and time consuming, and there may even have been better ways to perform the study. Nevertheless, it highlights that prolonged exposure to RF radiation at, or a little above, currently existing RF exposure regulation levels could lead to tumor development. The current RF exposure guidelines of 1.6 or 2.0 W/kg are promulgated with a reduction factor of 50 as a safety margin for the general public and to provide protection against presumed hazardous biological effects in humans , . The finding that RF exposure could lead to dose-dependent cancer development at levels that are the same or three times above current exposure guidelines is significant.
This implies that the safety margin may be no more than a factor of three. In fact, one recommendation (IEEE C95.1-2005) has a set of guidelines under controlled environments that allows local SARs of the brain and heart to be as much as 10 W/kg . An SAR of 10 W/kg is considerably higher than the 1.5, 3.0, and 6.0 W/kg used in the NTP study.” “Because all tissue and organs were similarly exposed and had comparable SARs, it is important for the NTP team to perform a statistical comparison of total primary malignancies in all tissue and organs observed in RF-exposed and concurrent control rats before issuing its final report. Given that hyperplasia (the enlargement of tissue or organs caused by an increased rate of cell growth in the initial stage of cancer development) often leads to neoplasm, the statistical analysis should also include findings of hyperplasia.” (p. 18)
“The FDA should be applauded for initiating and the NIEHS/NTP praised for having sponsored the research and conducted the cell-phone RF radiation studies. It’s important for the U.S. government to step in and conduct such research programs and not leave the matter entirely to the cell-phone industry. The wireless industry has had nearly free reign to develop and distribute cellular mobile phones and related RF devices as they see fit. The completion of this NTP study should not signify the end of the U.S. government’s role in supporting RF biological effects research because we continue to be exposed to more RF radiation every day , .” (p. 20)
“Malignant schwannoma in rat hearts were the most salient findings from the NTP RF bioassay. Acoustic schwannomas in human brains and malignant schwannomas in rat hearts were independently observed from two different body tissues in humans and rats. There could actually be a link between Schwann cells that wrap around both nerve tissues in the heart and along the auditory nervous system.” (p. 22)
“Because all tissue and organs were similarly exposed and had comparable SARs, it is important for the NTP team to perform a statistical comparison of total primary malignancies in all tissue and organs observed in RF-exposed and concurrent control rats before issuing its final report. Given that hyperplasia (the enlargement of tissue or organs caused by an increased rate of cell growth in the initial stage of cancer development) often leads to neoplasm, the statistical analysis should also include findings of hyperplasia.” (p. 22)
[Note: I provided similar suggestions for analysis of the data in my critique of the NTP study. (3)]
“Now that the NTP review panel has concluded there is clear evidence of carcinogenicity from long-term RF exposure in rats, is it conceivable that the IARC would upgrade its epidemiology-based classification of RF exposure to the next level of carcinogenicity to humans?
As noted earlier, the existing RF exposure guidelines of 1.6 or 2.0 W/kg are promulgated with a reduction factor of 50, as a safety margin for the general public. The finding that long-term RF exposure could lead to cancer development in rats at levels that are the same as or no greater than a factor of three above these exposure guidelines is significant.
While complacencies abound for short-term exposure guidelines in terms of providing safety protection, an outstanding question persists concerning the adequacy of these guidelines for safe, long-term exposure to RF radiation at or below 1.6 or 2.0 W/kg. Perhaps the time has come to judiciously reassess, revise, and update these guidelines." (pp. 22-23)
June 25, 2018
At the June 20, 2018 meeting of the Board of Scientific Counselors, NIEHS will make a presentation about the NTP cell phone radiation study followed by public comments and a discussion of the study. The Counselors will also discuss future studies of radio frequency radiation. For more information see the meeting agenda.
March 30, 2018 (Updated April 2)
Finally, my preliminary analysis of the overall tumor risk using summary data from the appendices to the NTP report found that male rats exposed to cell phone radiation were significantly more likely to develop a tumor than control rats overall (81% vs. 62%; p < .001), and even in the lowest cell phone radiation exposure group, 1.5 watts per kilogram (82% vs. 62%; p <.001).
March 16, 2018 (Updated March 25)
Public Comments on the NTP
Cell Phone Radiation Studies
The Ramazzini Institute in Italy will soon publish a study in the peer-reviewed journal, Environmental Research, which found that cell phone radiation caused malignant schwanomma in the hearts of male rats.
In this study of 2,448 male and female rats, the animals were exposed to 1.8 GHz GSM cell phone radiation for 19 hours per day from prenatal life until natural death. The cell phone phone radiation exposure in this study corresponds to what one could receive from a nearby cell phone tower. Hence, the exposures were much lower than in the NTP study. The SAR values in this study ranged from 0.001 W/kg to 0.1 W/kg as compared to 1.5 to 6.0 W/kg in the NTP study.
This is the fourth animal study to report increased cancer risk from exposure to low intensity microwave radiation. In addition to the NTP study (summarized below) and the U.S. Air Force study, Repacholi and colleagues (1997) found that female mice exposed to GSM-like cell phone radiation were twice as likely to develop lymphoma compared to unexposed control mice.
Nine peer-reviewed studies, including one cohort study, have found evidence in humans that long-term cell phone use is associated with increased risk of vestibular schwannomma, aka acoustic neuroma. Acoustic neuroma also arises from the Schwann cells, but unlike its counterpart in the heart, it is usually a slow-growing tumor and not cancerous.
NTP Cell Phone Radiation Cancer Study: A Public Health Perspective
Other organs in male rats were observed to have low incidences of tumors that exceeded those found in the unexposed controls, including the brain (i.e., glioma), the adrenal, pituitary, and prostate glands, the pancreas, and the liver.
Why is NTP downplaying the study results now?
Although this is the largest and most important animal study to examine tumor risk caused by cell phone radiation, both the NTP and the FDA are now downplaying the study results. Yet, in May, 2016, the NTP was so concerned about the increased risk of schwanomma and glioma in male rats, they released a partial report with these results because these are the same types of tumors found in several case-control studies of cell phone use among humans. What explains this turnaround?
"Same RF Cancer Data, Different Outlook"
Feb 2, 2018 (Updated Feb 6)
and Conducts Press Conference
On February 2, 2018, the National Toxicology Program (NTP) conducted a press conference and released two draft technical reports on the cell phone radiation studies -- one report on rats (TR-595) and one on mice (TR-596) and two supplemental data tables. The reports and data tables are available at http://bit.ly/NTPreports.
The recording and transcript of the press conference are available at http://bit.ly/NTPpress2-2-18.
For information about the upcoming review process in March see National Toxicology Program: Peer & public review of cell phone radiation study reports.
Dec 1, 2017
Microwave News reported today that the vice-chair of the International Commission on Non-Ionizing Radiation Protection (ICNIRP), Maria Feychting, has been trying to convince the scientific community to dismiss the $25 million cell phone cancer study conducted by the U.S. National Toxicology Program (NTP).
According to Microwave News, Feychting claimed at scientific meetings held in Germany and Sweden last month that the pathology analyses in the NTP study were not properly blinded. This issue was originally raised by an official reviewer of the study and was laid to rest in the NTP interim report released in May, 2016.
Several researchers in the U.S. and Europe expressed their concerns to Microwave News about Feychting's misguided efforts to undermine the credibility of the NTP cell phone study.
The Microwave News article reports that Feychting's declaration of personal interests filed with ICNIRP is incomplete as she has not fully disclosed potential conflicts of interest due to her role in the Swedish COSMOS study which has industry funding.
For more information see Microwave News.
Nov 28, 2017
This month the National Toxicology Program (NTP) of the National Institute of Environmental Health Sciences (NIEHS) updated the cell phone information page on its website and the fact sheet which summarizes the NTP cell phone radiation study. See below for a summary of the study and its findings.
The NTP's website indicates that the NIEHS has warned its "federal regulatory partners" (i.e., the Federal Communications Commission and the Food and Drug Administration) that the NTP's research found that cell phone radiation caused cancer in male rats to enable these agencies to provide the latest guidance to the public about safe ways to use cell phones and other radiofrequency radiation-emitting devices.
Following is some of the language which now appears on the NTP website.
Nov 21, 2017
McCormick D. Two-year oncogenicity evaluations of cell phone radiofrequency radiation in Sprague-Dawley rats and B6C3F1 mice. Toxicology Letters. 280 (Suppl. 1): S31. Oct 20, 2017. https://doi.org/10.1016/j.toxlet.2017.07.07
Epidemiology data concerning possible health effects of exposure to radiofrequency fields (RF) are conflicting. For this reason, well-designed and controlled studies in predictive laboratory animal models provide the best prospective opportunity to identify effects of RF exposure that may translate into human health hazards.
Sep 20, 2017
- in the frontal cortex of male mice from either CDMA or GSM cell phone radiation exposure,
- in peripheral leukocytes of female mice from CDMA exposure, and
- in the hippocampus of male rats from CDMA exposure.
The NTP is scheduled to publish a complete report about its cell phone radiation studies in early 2018. The FDA called for this research in 1999.
|Paper presented at annual meeting of Environmental Mutagenesis and Genomics Society, |
Raleigh, North Carolina, September 9-13, 2017.
Aug 31, 2017
Microwave News reported that the National Toxicology Program (NTP) will release the “complete results” of its $25 million project on cell phone cancer risks early next year. The release of these data had been expected by the end of this year.
"The complete results from all the rat and mice studies will be available for peer review and public comment by early 2018," according to a new statement on the NTP Web site.
To date, the study has reported increased risk of cancer in the brain and heart of male rats from exposure to second generation (2G) cell phone radiation and increased risk of DNA damage in mice and rats of both sexes. For more information about the results of this study see the rest of this post.
This NTP project is our nation's only major research on the effects of cell phone radiation since the 1990's. The FDA recommended that the NTP conduct these toxicology and carcinogenicity studies in 1999. The FDA letter calling for this study can be downloaded from the NIEHS website.
The NTP is still studying the effects of 2G cellphone radiation which may soon be obsolete.
What about 3G, 4G, and 5G? Why must we rely on research from other nations to inform us about the health effects of this environmental toxin?
The Federal government should be held accountable for the lack of research in the U.S. on the health effects of wireless radiation since the 1990's.
Government Failure to Address Wireless Radiation Risks
An Exposé of the FCC: An Agency Captured by the Industries it Regulates
April 4, 2017
”The genotoxicity paper was not accepted for stand-alone publication because the reviewers wanted additional detailed technical information on the methods used to expose the animals to radiofrequency radiation, as well as further placement of these findings in the context of the results of the two-year rodent studies. The complete results from all the rat and mice cancer studies remain in pathology review and the final determinations on the level of evidence for carcinogenic activity have not yet been made. For these reasons the decision was made to peer review and publish the genotoxicity data as part of the larger study in an NTP Technical Report.”For a summary of the evidence about DNA damage due to cell phone radiation see the posts below for June 10, 2016 and August 23, 2016.
Presentation on NTP Study to NIEHS Board of Scientific Counselors
On June 15, Dr. Michael Wyde, the director of the cell phone radiation studies conducted by the National Toxicology Program (NTP), provided an overview of the studies to the Board of Scientific Counselors of the National Institute of Environmental Health Sciences (NIEHS). He summarized the research designs and the partial results for the toxicology and carcinogenicity studies.
A video of the presentation including the presentation slides and the question and answer session is available at https://youtu.be/TCRF71eMZ1Q.
According to Dr. Wyde, the FDA recommended that the NTP conduct toxicology and carcinogenicity studies of cell phone radiation in 1999. Completion of these studies is expected by some time in 2018.
The 1999 FDA letter calling for this study can be downloaded from the NIEHS website.
June 24, 2016
NTP Toxicology & Carcinogenicity Cell Phone Radiofrequency Radiation Studies
Summary of Presentation at BioEM 2016 Meeting (Ghent, Belgium) by Michael Wyde, PhD, Director of NTP Studies of Cell Phone Radiation, NIEHS, June 8, 2016
Dr. Wyde explained the four reasons why the National Toxicology Program (NTP) decided to release partial study results at this time: 1) given widespread cellphone use, even a small increase in disease incidence could have major public health implications; 2) there is a high level of public and media interest in the study; 3) the tumor types observed in these studies are similar to those found in human studies of cellphone use; and 4) the results support the IARC classification of radiofrequency radiation as potentially cancer-causing in humans.
Dr. Wyde discussed the 5-day pilot studies conducted on young and aged mice and rats and on pregnant rats to determine the maximum intensity of cellphone radiation that could be employed in the subsequent studies without inducing any heating effect. He also described the 28-day pre-chronic toxicology studies and the 2-year toxicology and carcinogenicity studies.
For the pre-chronic studies, NTP selected SAR exposures of 0, 3, 6, and 9 watts/kilogram (W/kg) in rats and 0, 5, 10, and 15 W/kg in mice based on pilot study results. Pregnant rats were exposed prenatally and 28 days postnatal to 900 MHz cellphone radiation (GSM or CDMA). Five-week old mice were exposed to 1900 MHz cellphone radiation for 28 days.
Dr. Wyde reported statistically significant evidence of DNA damage from nonthermal exposure to cellphone radiation in mice as well as in rats:
- male rats: frontal cortex, hippocampus, liver, blood
- male mice: frontal cortex
- female rats: frontal cortex
- female mice: liver, blood
The slides for this presentation are available at:
June 13, 2016
Do Cellphones Cause Cancer? Probably, but it's Complicated
Dr. Chris Portier, Scientific American Blog, Jun 13, 2016
Setting the Record Straight on NTP Cell Phone Cancer Study
Dr. Ron Melnick Corrects ‘Misinformation,’ Rebuffed by the New York Times
Microwave News, Jun 10, 2016
American Cancer Society (ACS) responds to new study linking cell phone radiation to cancer
May 30, 2016
A German translation of this fact sheet is available at diagnose:funk. An Italian translation is available at Amica Associazione.
According to the report:
“Given the widespread global usage of mobile communications among users of all ages, even a very small increase in the incidence of disease resulting from exposure to RFR [radiofrequency radiation] could have broad implications for public health.”Overall, thirty of 540 (5.5%), or one in 18 male rats exposed to cell phone radiation developed cancer. In addition,16 pre-cancerous hyperplasias were diagnosed. Thus, 46 of 540, or one in 12 male rats exposed to cell phone radiation developed cancer or pre-cancerous cells as compared to none of the 90 unexposed male rats.
The two types of cancer examined in the exposed rats were glioma and schwannoma. Both types have been found in human studies of cell phone use.
In the group exposed to the lowest intensity of cell phone radiation (1.5 watts/kilogram or W/kg), 12 of 180, or one in 15 male rats developed cancer or pre-cancerous cells. In the highest exposure group (6 W/kg), 24 of 180, or one in 8 male rats developed cancer or pre-cancerous cells.
This latter finding has policy implications for the FCC's current cell phone regulations which allow cell phones to emit up to 1.6 W/kg at the head or near the body (partial body Specific Absorption Rate or SAR).
The NTP study is likely a "game-changer" as it proves that non-ionizing, radiofrequency radiation can cause cancer without heating tissue.
The results of the study reinforce the need for more stringent regulation of radiofrequency radiation and better disclosure of the health risks associated with wireless technologies -- two demands made by the International EMF Scientist Appeal -- a petition signed by 220 scientists who have published research on the effects of electromagnetic radiation.
Along with other recently published studies on the biologic and health effects of cell phone radiation, the International Agency for Research on Cancer of the World Health Organization should now have sufficient data to reclassify radiofrequency radiation from "possibly carcingogenic" to "probably carcinogenic in humans."
Why did cellphone radiation significantly increase cancer risk in male but not female rats? Perhaps, because glioma and heart schwannoma are less common in females. According to Microwave News (6/1/2016), the NTP report shows that among controls from past toxicology studies, males were ten times more likely to develop glioma than female rats (11 of 550 vs. 1 of 540). Also, males were twice as likely to develop heart schwannoma than female rats (9 of 669 vs. 4 of 699).
For each type of cell phone radiation, the study employed four groups of 90 rats -- a sham control group that was not exposed to radiation, and three exposed groups. The lowest exposure group had a SAR of 1.5 W/kg which is within the FCC's legal limit for partial body SAR exposure (e.g., at the head) from cell phones. The other exposure groups had SARs of 3 and 6 W/kg.
The FDA requested in May, 1999 that the NIEHS research the effects of cell phone radiation on DNA in animal models. FDA called this a "high priority." Seventeen years later the NIEHS has released only partial results from a series of studies which should have taken only a few years to conduct.
For references to the research that found increased risk of malignant and nonmalignant tumors among long-term cell phone users see http://bit.ly/WSJsaferemr.
The NTP report is available at http://bit.ly/NTPcell1.