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