Friday, December 7, 2018

Worldwide Radio Frequency Radiation Exposure Limits versus Health Effects

December 5, 2018

RFR Exposure Limits (Updated Dec. 7)

The World Health Organization's Global Health Observatory data repository publishes radio frequency radiation (RFR) exposure limits for the general public and for workers. The repository also has exposure limits for low frequency and static electromagnetic fields.

Radio frequency radiation includes the radiation emitted by cell phones and cordless phones, cell towers, microwave ovens, wireless baby monitors and smart meters, and Wi-Fi and Bluetooth devices including laptops, tablets, and wireless wearables.

The RFR exposure limit data for the general public in 36 nations (as of May 31, 2017) can be downloaded as a pdf document from http://bit.ly/RFlimitsXcountry.



WHO: RFR exposure limits for 36 nations
Health Effects

The RFR exposure limits were designed to protect the general public only from heating risks due to short-term exposure to this type of non-ionizing radiation. The limits were not designed to protect individuals from chronic exposure to low-intensity (i.e., non-thermal levels of) RFR. Yet the preponderance of peer-reviewed research on low-intensity RFR exposure finds biological effects and adverse health effects. Thus, one must carefully examine these studies to determine safe levels of RFR exposure.

BioInitiative 2012 provides charts that summarize RFR studies which employed low-intensity exposures. These charts can be downloaded as a pdf document from https://www.bioinitiative.org/rf-color-charts/.

BioInitiative 2012: first page of RF color chart 

Monday, November 19, 2018

National Toxicology Program: Peer & public review of cell phone radiation study reports

More Information: 


National Toxicology Program (NTP) Finds Cell Phone Radiation Causes Cancer

Nov 19, 2018

Review of the NTP and Ramazzini Institute Studies 
by the Swiss Expert Group on EMF and Non-Ionizing Radiation (BERENIS)

Conclusions

The NTP and Ramazzini studies are most comprehensive animal studies with regard to cancer and exposure to mobile phone and base station signals that have been conducted to date. The scientific quality and standard of laboratory techniques are high, especially in the NTP study…”

“The results of these two animal studies are of great scientific relevance and importance for health policy because according to the International Agency for Research on Cancer (IARC), positive results from animal studies with lifetime exposure are very important with regard to the classification of cancer risk of an agent, together with data from epidemiological and mechanistic studies. Based on the observed evidence regarding a correlation between mobile phone use and gliomas as well as acoustic neuroma, the latter data led to the IARC classification of mobile phone radiation as ‘possibly carcinogenic’ (group 2B) in 2011…”

“Despite the methodological differences, both new animal studies showed relatively consistent results in schwannomas and gliomas, as well as a dose-dependent trend to an increase in the carcinogenicity of these tumors. The NTP study used high whole-body doses (SAR – specific absorption rates) as compared to the regulatory limits for whole-body exposure recommended by ICNIRP. For the general public, this limit is 0.08 W/kg, with Switzerland additionally having introduced lower precautionary limits. The question arises of how transferable the NTP study results are to real-life exposure of the public, considering that mobile phone use exposes only parts of the body to EMF levels comparable to the ones applied to the whole animal by the NTP study. First, it is common practice in toxicology to study higher doses to evaluate possible hazards of an agent. Second, the NTP study found an increase in carcinogenicity for GSM and CDMA exposure conditions. Since the findings are similar for both types of exposure, they indicate that the modulation of the signals does not seem to be relevant. Third, mobile phone use can cause local SAR values up to 2 W/kg, averaged over a cube of 21 mm side length in the closest proximity of the phone (e.g. at the ear, cheeks, hand, pocket locations, etc.). Thus, the results of the NTP study are mostly relevant for the exposure situation when using a mobile phone close to the body. In contrast, the Ramazzini study observed carcinogenicity at levels as high as the environmental exposure limits, with no statistically significant effect at lower doses. However, a dose-dependent trend was found for malignant heart schwannomas, which is consistent with the findings of the NTP study. This may indicate that the non-significant increase in case numbers at lower exposure levels represents a true effect that has not reached statistical significance due to the given sample size.

In summary, BERENIS supports a precautionary approach for regulating RF EMF based on the findings and their evaluation. A full risk assessment analysis taking into account all available studies (animal studies and epidemiological studies) is necessary to assess whether the current standards should be changed."

Complete review:  http://bit.ly/NTPBerenis


Oct 24, 2018

Peer-reviewed comments on NTP cellphone radiation study by Hardell and Carlberg

    Hardell L, Carlberg M. Comments on the US National Toxicology Program technical reports on toxicology and carcinogenesis study in rats exposed to whole-body radiofrequency radiation at 900 MHz and in mice exposed to whole-body radiofrequency radiation at 1,900 MHz. International Journal of Oncology. Published Oct 24, 2018. https://doi.org/10.3892/ijo.2018.4606

    Abstract

    During the use of handheld mobile and cordless phones, the brain is the main target of radiofrequency (RF) radiation. An increased risk of developing glioma and acoustic neuroma has been found in human epidemiological studies. Primarily based on these findings, the International Agency for Research on Cancer (IARC) at the World Health Organization (WHO) classified in May, 2011 RF radiation at the frequency range of 30 kHz‑300 GHz as a ‘possible’ human carcinogen, Group 2B. A carcinogenic potential for RF radiation in animal studies was already published in 1982. This has been confirmed over the years, more recently in the Ramazzini Institute rat study. An increased incidence of glioma in the brain and malignant schwannoma in the heart was found in the US National Toxicology Program (NTP) study on rats and mice. The NTP final report is to be published; however, the extended reports are published on the internet for evaluation and are reviewed herein in more detail in relation to human epidemiological studies. Thus, the main aim of this study was to compare earlier human epidemiological studies with NTP findings, including a short review of animal studies. We conclude that there is clear evidence that RF radiation is a human carcinogen, causing glioma and vestibular schwannoma (acoustic neuroma). There is some evidence of an increased risk of developing thyroid cancer, and clear evidence that RF radiation is a multi‑site carcinogen. Based on the Preamble to the IARC Monographs, RF radiation should be classified as carcinogenic to humans, Group 1.




    Sep 24, 2018

    Peer-reviewed comments on NTP cell phone data for assessing human health risks
    by Ronald Melnick, Former NTP Director of Special Programs

    Melnick RL. Commentary on the utility of the National Toxicology Program study on cell phone radiofrequency radiation data for assessing human health risks despite unfounded criticisms aimed at minimizing the findings of adverse health effects. Environ Res. 2018 Sep 19;168:1-6. doi: 10.1016/j.envres.2018.09.010. 


    Abstract

    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.


    Note: Dr. Melnick was a senior toxicologist and Director of Special Programs in the Environmental Toxicology Program at the National Institute of Environmental Health Sciences, National Institutes of Health. He led the design of the cell phone radiation studies discussed in this commentary.


    Sep 6, 2018

    Official Summary of Peer Review Meeting about the NTP's Cell Phone 
    Radiofrequency Radiation Studies

    The official summary of the three-day peer review meeting to discuss the draft technical reports about the cell phone radiation studies conducted by the National Toxicology Program is now available.

    National Toxicology Program (NTP). Peer Review of the Draft NTP Technical Reports on Cell Phone Radiofrequency Radiation. National Institute of Environmental Health Sciences. 2018. pp. 1-51. 





    May 3, 2018

    Videos of NTP Peer Review Meeting

    Videos with closed captions for the peer review meeting of the draft NTP technical reports on cell phone radiation are now available on the NTP website at http://bit.ly/NTPvideos.





    April 10, 2018

    Experts Find "Clear Evidence" of Cancer from Cell Phone Radiation in NTP Study

    March 28, 2018 (Last updated April 10)

    Eleven experts convened by the National Toxicology Program (NTP) over a three day period to review the draft technical reports from the NTP's cell phone radiation studies concluded that there is "clear evidence" that exposure to cell phone radiation caused a rare cancer in the hearts of male rats, and "there is equivocal evidence" in the hearts of female rats.

    The expert panel also reported "some evidence" that cell phone radiation exposure caused brain cancer in male and female rats and cancer of the adrenal glands in male rats. 

    Additionally, "equivocal evidence" of cancer risk was reported in the pituitary, adrenal, and prostate glands and pancreas and liver in male rats and adrenal glands in female rats.

    The mice in the study, exposed to a different cell phone radiation frequency than the rats (1800 MHz vs. 900 MHz), displayed less evidence of cancer risk. Equivocal evidence of cancer risk from cell phone radiation was reported for lymphoma in male and female mice. Equivocal evidence was also reported for skin, lung, and liver cancer in male mice.

    In seven instances, the expert group upgraded the evaluations of evidence published by NTP staff in the draft technical reports. Thus, the NTP scientists appear to have been overly conservative in their assessment of the hazards of long-term exposure to cell phone radiation. According to a former NTP scientist, "There was never a time when so many upgrades were recommended."

    The following table based upon NTP's official summary of actions compares the evaluations of evidence of carcinogenicity prepared by NTP staff with the expert committee's findings. The two-page document which also contains the committee's findings for nonneoplastic lesions can be be downloaded from 
    http://bit.ly/NTP180330

    The presentations and oral public comments are available at the following link: http://bit.ly/2qmvtQg.

    Definitions
    Clear Evidence of Carcinogenic Activity is demonstrated by studies that are interpreted as showing a dose-related (i) increase of malignant neoplasms, (ii) increase of a combination of malignant and benign neoplasms, or (iii) marked increase of benign neoplasms if there is an indication from this or other studies of the ability of such tumors to progress to malignancy.
    Some Evidence of Carcinogenic Activity is demonstrated by studies that are interpreted as showing a chemical-related increased incidence of neoplasms (malignant, benign, or combined) in which the strength of the response is less than that required for clear evidence.
    Equivocal Evidence of Carcinogenic Activity is demonstrated by studies that are interpreted as showing a marginal increase of neoplasms that may be chemically related.
    No Evidence of Carcinogenic Activity is demonstrated by studies that are interpreted as showing no chemical-related increases in malignant or benign neoplasms.
    https://ntp.niehs.nih.gov/results/pubs/longterm/defs/index.html 
    Note: Although the definitions typically are applied to chemical agents, NTP also uses them with physical agents like cell phone radiation.

    PDF of document also includes nonneoplastic results & definitions: http://bit.ly/NTP180330



    March 16, 2018 (Updated March 25)

    To view webcast of NTP review meeting on March 26-28 from 8:30 AM - 5:00 PM EDT: 
    https://www.niehs.nih.gov/news/webcasts/cellphones_032618/

    The National Toxicology Program (NTP) requested public comments about the two draft NTP Technical Reports on Cell Phone Radiofrequency Radiation. Due to a lag between when comments were submitted and posted to the NTP website, below are links to selected comments from scientists and environmental health organizations about the reports.


    Public Comments: Scientists

    George Carlo, PhD, The Science and Public Policy Institute

    C.K. Chou, PhD, CK Chou Consulting

    Lennart Hardell, MD, PhD, Michael Carlberg, MSc, University Hospital, Ã–rebro, Sweden; Lena Hedendahl, MD, The Environment and Cancer Research Foundation

    Magda Havas, PhD, Trent University 

    Ronald Kostoff, PhD

    Ronald Melnick, PhD, Retired Senior Toxicologist, National Toxicology Program

    Joel Moskowitz, PhD, University of California, Berkeley

    Cindy Russell, MD, Physicians for Safe Technology

    Annie J. Sasco, MD, DrPH, SM, MPH, retired Director of Research,INSERM (French NIH); former Unit Chief, IARC-WHO


    Public Comments: Organizations

    Association Alerte Phonegate (Dr. Marc Arazi)

    EMF Research Committee, Korean Institute of Electromagnetic Engineering and Science (KIEES), South Korea

    Environmental Health Trust

    Environmental Working Group

    More Information

    Peer Review

    The members of the two peer review committees for the NTP meeting have been announced.

    David Eaton, PhD, University of Washington, Chair

    Technical Panel 1: Reverberation Chamber Exposure System: Assess the reverberation chamber technology for evaluating the effects of cell phone radiofrequency radiation exposure in rats and mice.

    Members:
    Frank Barnes, PhD, University of Colorado Boulder
    Asimini Kiourti, PhD, Ohio State University
    James Lin, PhD, University of Illinois at Chicago

    Technical Panel 2: NTP Findings in Rats and Mice: (1) Review and evaluate the scientific and technical elements of the study and its presentation; (2) Determine whether the study’s experimental design, conduct, and findings support the NTP’s conclusions regarding the carcinogenic activity and toxicity of the test agent.

    Members:
    Rick Adler, DVM, PhD, DACVP, Glaxo Smith Kline
    Lydia Andrews-Jones, DVM, PhD, DACVP, Allergan, Inc,
    J. Mark Cline, DVM, PhD, DACVP, Wake Forest School of Medicine
    George Corcoran, PhD, ATS, Wayne State University
    Susan Felter, PhD, Proctor & Gamble
    Jack Harkema, DVM, PhD, DACVP, Michigan State University
    Wolfgang Kaufmann, DVM, PhD, DECVP, Fellow IATP, Merck (retired)
    Tyler Malys, PhD, National Cancer Institute
    Kamala Pant, MS, BioReliance
    Matthias Rinke, DVM, PhD, FTA Pathology, CVP, Fellow IATP, Bayer Pharma (retired)
    Laurence Whiteley, DVM, PhD, DACVP, Pfizer 



    Jan 29, 2018 (Updated Jan 31, 2018)

    The following information was excerpted from the Federal Register.

    On January 29, 2018, the National Toxicology Program (NTP) announced a meeting to peer review two draft NTP Technical Reports on Cell Phone Radiofrequency Radiation. These reports present the results of NTP studies conducted to evaluate the impact of cell phone radiofrequency radiation exposure in mice and rats.

    The peer-review meeting will be held at the National Institute of Environmental Health Sciences (NIEHS) in Research Triangle Park, NC and is open to the public. Registration is requested for attendance at the meeting either in-person or by webcast and to present oral comments. Information about the meeting and registration will be available at https://ntp.niehs.nih.gov/​go/36051.

    Meeting

    Tentatively scheduled for March 26, 2018, 8:30 a.m. to adjournment on March 28, 2018, at approximately 5:00 p.m. Eastern Daylight Time. The preliminary agenda will be available at https://ntp.niehs.nih.gov/​go/​36051 and will be updated one week before the meeting.

    Document Availability

    The NTP will post the two draft technical reports at 12 noon (Eastern Standard Time) on Friday, February 2 on the NTP web site: https://ntp.niehs.nih.gov/​go/​36051.

    Deadlines

    Written Public Comment Submissions: March 12, 2018
    Registration for Oral Comments: March 12, 2018
    Registration to Attend Meeting In-person: March 28, 2018
    Registration to View Webcast: March 28, 2018

    Background

    Personal (cellular) telecommunications is a rapidly evolving technology that uses radiofrequency energy or radiation for mobile communication. According to a 2016 survey, 95 percent of American adults now use cell phones. Given such broad use, adverse health effects shown to be associated with cell phone use could be a widespread public health concern.

    The U.S. Food and Drug Administration (FDA) nominated cell phone radiofrequency radiation for NTP study because (a) widespread human exposure is possible, (b) current exposure guidelines are based largely on protection from acute injury due to thermal effects, (c) little is known about the potential health effects of long-term exposure to radiofrequency radiation, and (d) currently available human studies have found limited evidence of an increased risk of cancer from cell phone use.

    NTP studied in rats and mice the effects of exposure to cell phone radiofrequency radiation from two system modulations: Global System for Mobile Communications and Code Division Multiple Access. NTP released the “Report of Partial Findings from the National Toxicology Program Carcinogenesis Studies of Cell Phone Radiofrequency Radiation in Hsd: Sprague Dawley SD Rats (Whole Body Exposure)” in May 2016 (https://doi.org/​10.1101/​055699). The partial findings will be included in the draft NTP technical report for rats. The two draft NTP technical reports present results for all NTP studies on rats and mice on the toxicity and carcinogenicity of cell phone-emitted radiofrequency radiation.

    Public Comment Registration

    NTP invites written and oral public comments on the draft NTP technical reports: Guidelines for Public Comments.

    The deadline for submission of written comments is March 12, 2018. Written public comments should be submitted through the meeting website. Persons submitting written comments should include name, affiliation, mailing address, phone, email, and sponsoring organization (if any). Written comments received in response to this notice will be posted on the NTP website, and the submitter will be identified by name, affiliation, and sponsoring organization (if any). Comments that address scientific or technical issues will be forwarded to the peer-review panel and NTP staff prior to the meeting.

    Registration to provide oral comments is on or before March 12, 2018, at https://ntp.niehs.nih.gov/​go/​36051. Registration is on a first-come, first-served basis, and registrants will be assigned a number in their confirmation email. Oral comments may be presented in person at NIEHS or by teleconference line. The access number for the teleconference line will be provided to registrants by email prior to the meeting. Each organization is allowed one time slot per comment period. The agenda allows for two public comment periods: The first comment period on the exposure system (12 commenters, up to 5 minutes per speaker), and the second comment period on the NTP findings in rats and mice (24 commenters, up to 5 minutes per speaker). After the maximum number of speakers per comment period is exceeded, individuals registered to provide oral comment will be placed on a wait list and notified should an opening become available. Commenters will be notified after March 12, 2018, the deadline to register for oral public comments, about the actual time allotted per speaker.

    If possible, oral public commenters should send a copy of their slides and/or statement or talking points to Canden Byrd by email: NTP-Meetings@icf.com by March 12, 2018.

    Background Information on NTP Peer-Review Panels

    NTP panels are technical, scientific advisory bodies to provide independent scientific peer review. These panels help ensure transparent, unbiased, and scientifically rigorous input to the program. Scientists interested in serving on an NTP panel should provide their current curriculum vitae to Canden Byrd by email: NTP-Meetings@icf.com.

    More information about the meeting

    http://bit.ly/FedRegNTP

    https://ntp.niehs.nih.gov/​go/​36051

    Information about NTP Partial Report of Findings

    http://bit.ly/NTPpartreport


    Tuesday, November 13, 2018

    Breaking News: Yale Univ. / Connecticut Health Dept. Study: Heavy Cell Phone Use Linked to Thyroid Cancer

    Yale University / Connecticut Health Department Study Finds Heavy Cell Phone Use Linked to Thyroid Cancer

    From Carlberg et al. (2016)

    The first case-control study examining the association between cell phone use and thyroid cancer found elevated risks of thyroid cancer among heavier, long-term cell phone users.

    At greater risk of thyroid cancer were individuals who used a cell phone for more than 15 years, for more than two hours per day, or for a greater number of lifetime hours. Also, those who made the most cell phone calls in their lifetime were at increased risk.

    Men who used cell phones for more than 15 years had over twice the risk of thyroid cancer as compared to non-cell phone users after controlling for other factors. Women who used cell phones for more than two hours per day had a 52% greater risk of thyroid cancer as compared to non-cell phone users.

    Although the key findings in this study were of borderline statistical significance, this may be due to the relatively small sample size, especially for males. The study included 462 histologically-confirmed thyroid cancer cases and 498 population-based controls. Also, the study did not control for cordless phone use which may be a risk factor for thyroid cancer.

    The study, published online in the Annals of Epidemiology on October 29, was conducted by researchers from the Yale School of Medicine and the Connecticut Health Department.

    The authors recommended more research since the results from this study may not be generalizable to current cell phone users due to changing technology and patterns of use (e.g., hands-free use, texting). The authors noted that smart phones were not in common use during the period prior to 2010-2011 when the data for this study were collected. The majority of study participants did not start using cell phones until age 21. Future research should determine if age of first cell phone use is associated with greater thyroid cancer risk.

    The authors reported that thyroid cancer is the fastest growing cancer in the U.S. Incidence has nearly tripled since the 1980’s from four per 100,000 in 1980 to fifteen per 100,000 in 2014 making this the fifth most common cancer among women in the country. Although over-diagnosis is believed to account for about half of this increase, the remainder is likely due to changing environmental and lifestyle factors.

    Yawei Zhang, MD, PhD, of the Yale School of Medicine and Cancer Center was the senior author of this paper. The research was supported by the American Cancer Society, the U.S. National Institutes of Health, and the Ministry of Science and Technology of the People’s Republic of China.

    My comments: The National Cancer Institute (NCI) estimates that 53,990 new cases of thyroid cancer will be diagnosed in 2018 making this the 12th most common cancer in the U.S. Rates for new thyroid cancer cases have increased 3.1% per year over the last ten years (on average) based upon an analysis of data from the NCI Surveillance, Epidemiology, and End Results-9 (SEER-9) cancer registry program.

    Since smart phones are more likely to have cell antennas located in the bottom of the phones than earlier cell phone models, the peak radiation exposure from a smart phone is more likely in the neck than in the brain. Hence, I would hypothesize that the association between cell phone use and thyroid cancer has increased in recent years. The switch from “candy bar" and flip phones to smart phones could explain upward trends over time in thyroid cancer incidence and relatively flat trends in brain cancer observed in some countries.

    Luo J, Deziel NC, Huang H, Chen Y, Ni X, Ma S, Udelsman R, Zhang Y. Cell phone use and risk of thyroid cancer: a population-based case-control study in Connecticut. Annals of Epidemiology. Published online Oct 29, 2018. https://doi.org/10.1016/j.annepidem.2018.10.004.



    Abstract

    Purpose. This study aims to investigate the association between cell phone use and thyroid cancer.

    Methods.  A population-based case-control study was conducted in Connecticut between 2010 and 2011 including 462 histologically confirmed thyroid cancer cases and 498 population-based controls. Multivariate unconditional logistic regression was used to estimate odds ratios (OR) and 95% confidence intervals (95% CI) for associations between cell phone use and thyroid cancer.

    Results. Cell phone use was not associated with thyroid cancer (OR: 1.05, 95% CI: 0.74-1.48). A suggestive increase in risk of thyroid microcarcinoma (tumor size ≤10mm) was observed for long-term and more frequent users. Compared to cell phone non-users, several groups had non-statistically significantly increased risk of thyroid microcarcinoma: individuals who had used a cell phone >15 years (OR: 1.29, 95% CI: 0.83-2.00), who had used a cell phone >2 hours per day (OR: 1.40, 95% CI: 0.83-2.35), who had the most cumulative use hours (OR: 1.58, 95% CI: 0.98-2.54), and who had the most cumulative calls (OR: 1.20, 95% CI: 0.78-1.84).

    Conclusion. This study found no significant association between cell phone use and thyroid cancer. A suggestive elevated risk of thyroid microcarcinoma associated with long-term and more frequent uses warrants further investigation.


    More information:

    Friday, November 9, 2018

    NTP Cell Phone Radiation Study: Final Reports


    November 1, 2018 (Updated: Nov 16, 2018)

    The official summaries of the final reports of the National Toxicology Program (NTP) cell phone radiation studies, the NTP press release, and a new NTP fact sheet can be found below along with the FDA press release that addresses these studies.


    In 1999, the U.S. Food and Drug Administration (FDA) asked the NTP to conduct cell phone radiation studies on animals.The FCC's exposure guidelines for cell phone radiation adopted in 1996 and still in effect today were designed to protect humans from thermal (or heating) effects. However, scientists at that time were concerned that low level exposures could increase cancer risk through nonthermal mechanisms. This was the basis for the FDA's request to the NTP in 1999:
    "The existing exposure guidelines are based on protection from acute injury from thermal effects of RFR exposure, and may not be protective against any non-thermal effects of chronic exposures. Animal exposure research reported in the literature suggests that low level exposures may increase the risk of cancer by mechanisms yet to be elucidated, but the data is conflicting and most of thisresearch was not conducted with actual cellular phone radiation."

    Nineteen years later on November 1, 2018, the NTP published the final reports on the effects of two-years of exposure to 2G (GSM and CDMA) cell phone radiation on rats and mice. Since these studies utilized radiation levels that would not induce significant heating (greater than one degree Centigrade), any observed effects would be due to nonthermal mechanisms (e.g., oxidative stress).

    The NTP final reports found "clear evidence" of increased cancer risk in male rats from low level (i.e., nonthermal) exposures (c.f., heart schwannoma). Furthermore, many hundreds of peer-reviewed studies have found evidence of biologic and health effects from low level exposures to cell phone radiation. Hence, the FCC's exposure guidelines must be re-assessed as they are likely inadequate to protect human health. 

    --

    Following are my comments about the studies based primarily on the NTP's press release and media teleconference conducted on October 31.

    The NTP final reports indicate that the NTP staff has accepted the peer review committee’s recommendations about the carcinogenicity of cell phone radiation. A summary of these recommendations can be found at: http://bit.ly/NTP180330 

    Information about the NTP study and the peer review process is available at:

    National Toxicology Program (NTP) Finds Cell Phone Radiation Causes Cancer

    Besides "clear evidence" (the highest category) of cancer in male rats from long term exposure to cell phone radiation, the NTP found degeneration in the hearts of male and female rats, decreased birth weights in rats exposed prenatally, and DNA damage in mice and rats as compared to sham controls.

    Nonetheless, the NTP seems to be downplaying the significance of the results for public health of their $30 million cell phone radiation studies.

    In my opinion, the results of the NTP cell phone radiation studies in conjunction with the results of the recent Ramazzini Institute study provide conclusive evidence that long term exposure to cell phone radiation causes DNA damage and cancer.

    To follow up on the comments I submitted to the NTP in March, during the telebriefing yesterday, I asked whether the NTP conducted a statistical analysis of the overall tumor rates (across all organs) for each group. Dr. Bucher responded that there is a "philosophical difference" about whether to examine overall tumor risk in toxicology studies because the overall tumor rate is generally "driven by common tumors." Thus, such an analysis is usually overly conservative (i.e., biased toward the null).

    However, there is a precedent for conducting such an analysis in the NTP cellphone studies since the entire body of the animals was exposed to cellphone radiation. A 5-year, $5 million Air Force study found low incidences of many types of tumors in male rats exposed to microwave radiation (Chou et al, 1992). In that study, the exposed rats were three times more likely to get cancer than the control rats. The study employed much lower intensity microwave radiation than the NTP studies. 

    We should learn from our colleagues who study tobacco research. Early toxicology research on the effects of tobacco found low incidences of many types of tumors among animals exposed to tobacco smoke. Scientists dismissed this evidence because they assumed an agent could not cause cancer in different types of tissue. History later proved them wrong.

    Dr. Wyde's response to my question was that the overall tumor rates appear in Appendices A through D of the NTP final reports. Unfortunately, these results remain buried in the appendices when in my opinion they should be featured as key results of the study.

    The data in the following tables were extracted from Tables A2 and C2 in the NTP final report on the 2-year rat study (pp. 149-150 and 203-204). The tumor rates across all organs for the male rats are tabled by exposure condition for GSM and CDMA cell phone radiation for benign tumors, malignant tumors, and for either type of tumors.
















































    The above tables show that the highest overall tumor rates (i.e., the presence of either a benign or malignant tumor in any organ) were found in male rats exposed to 3 watts per kilogram of either GSM (87%) or CDMA (84%) cell phone radiation, and the lowest rate was found in the sham control group (63%). The exposed groups had significantly higher overall tumor rates than the sham controls even after adjusting for survival differences among the groups (see the Poly-3 test p values).

    The highest cancer rates (i.e., malignant tumors) were found in male rats exposed to 3 watts per kilogram of either GSM (42%) or CDMA (46%) cell phone radiation and the lowest rate was found in the sham control group (27%). Here too, the exposed groups had significantly higher overall cancer rates than the sham controls.

    Moreover, male rats in the lowest exposure groups (1.5 watts per kilogram) had significantly higher rates of benign tumors (76% for GSM; 73% for CDMA) than the sham control group (54%).

    Is it justifiable to bury these results in the appendices to the final reports?

    The results of the NTP and Ramazzini Institute studies reaffirm the concerns raised by the scientific community in the International EMFScientist Appeal about the harm caused by chronic exposure to low-intensity electromagnetic fields (EMF). The Appeal, which has been signed by more than 240 EMF scientists who have published over 2,000 papers on EMF and biology or health in professional journals, calls for warning the public and strengthening EMF guidelines, especially to protect children and pregnant women.

    We are guinea pigs in a massive technological experiment that threatens our health. Our government needs to determine what constitutes a safe level of long-term exposure to wireless radiation and strengthen the FCC's radio frequency exposure guidelines. In the meantime, the government should impose a moratorium on technologies that increase our exposure to wireless radiation, especially new forms of wireless radiation like 5G cellphone radiation.

    Related posts:




    --


    NTP Final Reports

    National Toxicology Program. NTP technical report on the toxicology and carcinogenesis studies in Hsd:Sprague Dawley SD rats exposed to whole-body radio frequency radiation at a frequency (900 MHz) and modulations (GSM and CDMA) used by cell phones. NTP TR 595. Research Triangle Park, NC. November, 2018. https://www.niehs.nih.gov/ntp-temp/tr595_508.pdf


    SUMMARY

    Background

    Cell phones utilize a specific type of radio waves, or radio frequency radiation (RFR), to transmit between the devices and the network. Exposure of people to RFR occurs primarily through use of cell phones and other wireless devices. We studied the effects of nearly lifetime exposures to two different types, or modulations, of RFR (GSM and CDMA) used in cellular telephone networks in the United States in male and female rats and mice to identify potential toxicity or cancer-related hazards.

    Over the years, cell phone technology has evolved from the original analog technology (1G) commercially introduced in the 1980s to digital networks that supplanted analog phones. The digital network, referred to as 2G or the 2nd generation of technology, was commercially launched in the 1990s, with 3G and 4G subsequently deployed in the intervening years. When the current studies were being designed, 2G technology was the industry standard, and 3G technologies were under development. While newer technologies have continued to evolve, it is important to note that these technologies have not completely replaced the older technologies. In fact, today’s phones are very complex in that they contain several antennas, for wi-fi, GPS, 2G/3G bands, etc. Thus, the results of these studies remain relevant to current exposures, although the power levels of the exposures were much higher than typical patterns of human use.

    Methods

    We exposed groups of 90 male and 90 female rats to 1.5, 3, or 6 W/kg RFR that was modulated in the same manner in which signals are emitted from cell phones and other similar wireless communication devices. Other groups of male and female rats housed in the same type of chambers without any exposure to RFR were used as the controls. Animals were exposed to RFR in utero, postnatally, and during adulthood for approximately 9 hours a day, 7 days per week, for 2 years. Tissues from more than 40 sites were examined for every animal.

    Results

    Exposure to RFR caused decreased body weights of pregnant rats during gestation and lower birth weights in their offspring. However, a few weeks after birth body weights returned to normal and were similar to non-exposed rats. In general, RFR-exposed male rats lived longer than non-exposed rats. The higher survival of exposed males was attributed to a lower severity of a natural, age-related kidney disease typically observed in male rats at the end of these types of studies, which may have been related to the RFR exposure. In both studies (GSM and CDMA), exposure to RFR in male rats resulted in higher numbers of animals with tumors of the heart and brain. In the GSM study, increased numbers of animals with tumors of the adrenal gland were also observed in exposed males. In both studies, there were tumors that occurred in several organs that we were unable to clearly determine whether these resulted from exposure or were just incidental findings. For the GSM studies, these lesions included tumors of the prostate gland, pituitary gland, and pancreas in males and of the heart in females. For the CDMA studies, these equivocal lesions included tumors of the pituitary gland and liver in males and of the heart, brain, and adrenal gland of females.

    Conclusions

    In males for both GSM- and CDMA-modulated RFR, we conclude that exposures increased the number of animals with tumors in the heart. Tumors of the brain were also considered to be related to exposure; and increased numbers of male rats with tumors of the adrenal gland were also related to exposure. We are uncertain whether occurrences of prostate gland, pituitary gland, and pancreatic islet tumors in male rats exposed to GSM-modulated RFR and pituitary gland and liver tumors in male rats exposed to CDMA-modulated RFR were related to RFR exposures. This was also the case with female rats, where we conclude that exposure to GSM- or CDMA-modulated RFR may have been related to tumors in the heart. For females exposed to CDMA-modulated RFR, occurrences of brain and adrenal gland tumors may have been related to exposure.

    --

    National Toxicology Program. NTP technical report on the toxicology and carcinogenesis studies in B6C3F1/N mice exposed to whole-body radio frequency radiation at a frequency (1900 MHz) and modulations (GSM and CDMA) used by cell phones. NTP TR 596.  Research Triangle Park, NC. November, 2018. https://www.niehs.nih.gov/ntp-temp/tr596_508.pdf

    SUMMARY

    Background

    Cell phones utilize a specific type of radio waves, or radio frequency radiation (RFR), to transmit voice and data between the devices and the network. Exposure of people to RFR occurs primarily through use of cell phones and other wireless devices. We studied the effects of nearly lifetime exposure to two different types, or modulations, of RFR (GSM and CDMA) used in cellular telephone networks in the United States in male and female rats and mice to identify potential toxic or cancer-related hazards.

    Over the years, cell phone technology has evolved from the original analog technology (1G) commercially introduced in the 1980s to digital networks that supplanted analog phones. The digital network, referred to as 2G or the 2nd generation of technology, was commercially launched in the 1990s, with 3G and 4G subsequently deployed in the intervening years. When the current studies were being designed, 2G technology was the industry standard, and 3G technologies were under development. While newer technologies have continued to evolve, it is important to note that these technologies have not completely replaced the older technologies. In fact, today’s phones are very complex in that they contain several antennas, for Wi-Fi, GPS, 2G/3G bands, etc. The results of these studies remain relevant to current exposures, although the power levels of the exposures were much higher than typical patterns of human use.

    Methods

    We exposed groups of 90 male and 90 female mice to 2.5, 5, or 10 W/kg RFR that was modulated in the same manner in which signals are emitted from cell phones and other similar wireless communication devices. Other groups of male and female mice housed in the same type of chamber without any exposure to RFR were used as the controls. Animals were exposed to RFR for approximately 9 hours a day, 7 days per week, for 2 years. Tissues from more than 40 sites were examined for every animal.

    Results

    There were higher rates of survival in males at the low (2.5 W/kg) and mid (5 W/kg) exposures to CDMA- and GSM-modulated RFR, respectively. Body weights in the exposed groups of animals were similar to their controls. In both studies (GSM and CDMA), there were higher incidences of malignant lymphoma in all groups of female mice exposed to RFR compared to controls. However, the incidences in all of the exposed females were within the range historically observed in this strain of mouse in other NTP studies. There were higher incidences of skin and lung tumors in males exposed to the highest two levels of GSM-modulated RFR (5 and 10 W/kg), and of liver tumors at the mid-dose (5 W/kg) of CDMA-modulated RFR.

    Conclusions

    For GSM-modulated RFR, we conclude that exposure to RFR may have caused tumors in the skin and lungs of male mice and malignant lymphomas in female mice. For CDMA-modulated RFR, we conclude that exposure to RFR may have caused tumors in the liver of male mice and malignant lymphomas in female mice.

    --


    NTP Press Release (November 1, 2018)

    High exposure to radio frequency radiation associated with cancer in male rats

    National Toxicology Program releases final reports on rat and mouse studies of radio frequency radiation like that used in 2G and 3G cell phone technologies

    Press Release, National Toxicology Program, Nov 1, 2018

    The National Toxicology Program (NTP) concluded there is clear evidence that male rats exposed to high levels of radio frequency radiation (RFR) like that used in 2G and 3G cell phones developed cancerous heart tumors, according to final reports released today. There was also some evidence of tumors in the brain and adrenal gland of exposed male rats. For female rats, and male and female mice, the evidence was equivocal as to whether cancers observed were associated with exposure to RFR. The final reports represent the consensus of NTP and a panel of external scientific experts who reviewed the studies in March after draft reports were issued in February.

    “The exposures used in the studies cannot be compared directly to the exposure that humans experience when using a cell phone,” said John Bucher, Ph.D., NTP senior scientist. “In our studies, rats and mice received radio frequency radiation across their whole bodies. By contrast, people are mostly exposed in specific local tissues close to where they hold the phone. In addition, the exposure levels and durations in our studies were greater than what people experience.”

    The lowest exposure level used in the studies was equal to the maximum local tissue exposure currently allowed for cell phone users. This power level rarely occurs with typical cell phone use. The highest exposure level in the studies was four times higher than the maximum power level permitted. 

    “We believe that the link between radio frequency radiation and tumors in male rats is real, and the external experts agreed,” said Bucher. 

    The $30 million NTP studies took more than 10 years to complete and are the most comprehensive assessment, to date, of health effects in animals exposed to RFR with modulations used in 2G and 3G cell phones. 2G and 3G networks were standard when the studies were designed and are still used for phone calls and texting.

    “A major strength of our studies is that we were able to control exactly how much radio frequency radiation the animals received — something that’s not possible when studying human cell phone use, which has often relied on questionnaires,” said Michael Wyde, Ph.D., lead toxicologist on the studies.

    He also noted the unexpected finding of longer lifespans among the exposed male rats. “This may be explained by an observed decrease in chronic kidney problems that are often the cause of death in older rats,” Wyde said.

    The animals were housed in chambers specifically designed and built for these studies. Exposure to RFR began in the womb for rats and at 5 to 6 weeks old for mice, and continued for up to two years, or most of their natural lifetime. The RFR exposure was intermittent, 10 minutes on and 10 minutes off, totaling about nine hours each day. RFR levels ranged from 1.5-6 watts per kilogram in rats, and 2.5-10 watts per kilogram in mice.

    These studies did not investigate the types of RFR used for Wi-Fi or 5G networks.

    “5G is an emerging technology that hasn’t really been defined yet. From what we currently understand, it likely differs dramatically from what we studied,” said Wyde.

    For future studies, NTP is building smaller RFR exposure chambers that will make it easier to evaluate newer telecommunications technologies in weeks or months, rather than years. These studies will focus on developing measurable physical indicators, or biomarkers, of potential effects from RFR. These may include changes in metrics like DNA damage in exposed tissues, which can be detected much sooner than cancer.


    The U.S. Food and Drug Administration nominated cell phone RFR for study by NTP because of widespread public use of cell phones and limited knowledge about potential health effects from long-term exposure. NTP will provide the results of these studies to FDA and the Federal Communications Commission, who will review the information as they continue to monitor new research on the potential effects of RFR.

    NTP uses four categories to summarize the evidence that a substance may cause cancer:

    ·      Clear evidence (highest)
    ·      Some evidence
    ·      Equivocal evidence
    ·      No evidence (lowest) 


    --

    NTP Cell Phone Radiation Fact Sheet (November, 2018)






    https://www.niehs.nih.gov/health/materials/cell_phone_radiofrequency_radiation_studies_508.pdf

    --

    FDA contradicts NTP

    According to NTP Report (NTP TR 595, p. 25):

    "The FDA does not currently regulate the use of wireless communications devices or the devices themselves. The FDA also does not require safety evaluations for radiation-emitting wireless communication devices. It does maintain the authority to take regulatory action if it is demonstrated that exposure to the emitted cell phone RFR from these devices is hazardous to the user."
    Dr. Bucher, an NTP senior scientist and former associate director, stated in the NTP's press release (Nov 1, 2018), "We believe that the link between radio frequency radiation and tumors in male rats is real, and the external experts agreed.” 

    Nonetheless, the FDA dismissed the NTP results in its press release. FDA Center Director, Dr. Shuren, stated “these findings should not be applied to human cell phone usage ... we believe the existing safety limits for cell phones remain acceptable for protecting the public health.” 

    This is rather odd since the FDA requested that the NTP conduct these animals studies in 1999 because the agency was concerned that the FCC's cell phone "safety limits" did not protect human safety since the limits were based on a thermal model. Now that we have hundreds of animal studies demonstrating non-thermal biologic effects and several major epidemiologic studies demonstrating increased cancer risk in heavy cell phone users, FDA should be more concerned than ever that the FCC exposure guidelines are inadequate.

    --

    FDA. Press Release: Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health on the National Toxicology Program’s report on radiofrequency energy exposure. FDA, Nov 1, 2018.

    "We know that cell phones are an important, everyday tool to most Americans. We use them now for much more than just talking—from booking travel on an app to using mobile wallets to pay for groceries. Our ubitquitious use of cell phones inevitably means that we must continue to review and ensure their safety.
    The Food and Drug Administration is charged with ensuring cell phones— and any radiation-emitting electronic product—are safe for the public to use. Our scientific expertise and input, along with other health agencies, are used by the Federal Communications Commission (FCC) to set the standards for exposure limits of radiation from cell phones, called radiofrequency energy.
    We have relied on decades of research and hundreds of studies to have the most complete evaluation of radiofrequency energy exposure. This information has informed the FDA’s assessment of this important public health issue, and given us the confidence that the current safety limits for cell phone radiofrequency energy exposure remain acceptable for protecting the public health.
    When new studies or information becomes available, the FDA conducts thorough evaluations of the data to continually inform our thinking. We reviewed the recently finalized research conducted by our colleagues at the National Toxicology Program (NTP), part of the National Institute of Environmental Health Sciences within the National Institutes of Health, on radiofrequency energy exposure. After reviewing the study, we disagree, however, with the conclusions of their final report regarding “clear evidence” of carcinogenic activity in rodents exposed to radiofrequency energy.
    In the NTP study, researchers looked at the effects of exposing rodents to extremely high levels of radiofrequency throughout the entire body. This is commonly done in these types of hazard identification studies and means that the study tested levels of radiofrequency energy exposures considerably above the current whole body safety limits for cell phones. Doing this was intended to help contribute to what we already understand about the effects of radiofrequency energy on animal tissue. In fact, we only begin to observe effects to animal tissue at exposures that are 50 times higher than the current whole body safety limits set by the FCC for radiofrequency energy exposure.
    Our colleagues at NTP echoed this point in a statement earlier this year about their draft final report, including the important note that “these findings should not be directly extrapolated to human cell phone usage.”
    We agree that these findings should not be applied to human cell phone usage.
    NTP hosted a three-day peer review of this study in March, as part of their normal process for issuing scientific reports. The FDA was not a participant in that process, but was invited to observe the panel discussions, which included an assessment of the study methods and data by a panel of 15 peer reviewers to determine the basis of evidence for the final report. Based on their assessment, the panel voted to upgrade the conclusions from some evidence to clear evidence for malignant heart schwannomas in male rats, and from equivocal (ambigious) to some evidence for malignant gliomas of the brain and benign tumors of the adrenal gland in male rats. It’s important to note that the vote does not mean new data or findings were reported in the final assessment.
    In addition, as we’ve noted previously, there were unusual findings in the study, such as: the rats exposed to whole body radiofrequency energy lived longer than rats that were not exposed to any radiation (control group); only male rats exposed to the highest radiofrequency energy dosage developed a statistically significant number of heart schwannomas, which are very rare in humans, when compared to the control group in this experiment. There was also no true dose response, or a lack of a clear relationship between the doses of radiation administered to the animals and their subsequent tumor rate.
    Researchers will need to consider all of the findings when exploring future human epidemiological studies.
    As scientists, we welcome new studies. Animal studies like this one contribute to our discussions on this topic, but we must remember the study was not designed to test the safety of cell phone use in humans, so we cannot draw conclusions about the risks of cell phone use from it. We also must thoroughly evaluate and take into consideration the totality of the data, and do so within the context of the complete body of evidence rather than drawing conclusions from the results of a single study.
    As part of our commitment to protecting the public health, the FDA has reviewed, and will continue to review, many sources of scientific and medical evidence related to the possibility of adverse health effects from radiofrequency energy exposure in both humans and animals and will continue to do so as new scientific data are published.
    Based on our ongoing evaluation of this issue, the totality of the available scientific evidence continues to not support adverse health effects in humans caused by exposures at or under the current radiofrequency energy exposure limits. We believe the existing safety limits for cell phones remain acceptable for protecting the public health.
    The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products."