Friday, November 9, 2018

NTP Cell Phone Radiation Study: Final Reports


November 1, 2018 (Updated: Nov 9, 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. 


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. 

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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:




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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.

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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.

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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) 


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NTP Cell Phone Radiation Fact Sheet (November, 2018)






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

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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.