TR Daily: NTP Upgrades Confidence Levels for RFR-Tumor Links

Reprinted with permission of TR Daily, November 01, 2018

The National Toxicology Program (NTP) announced today that is has accepted the recommendations of an expert peer-review panel and upgraded the confidence levels of carcinogenic activity in rats from exposure to 2G and 3G radiofrequency radiation.

However, the NTP and others cautioned that the results cannot be extrapolated to predict the impacts of human cellphone use. But advocates for tighter radio frequency radiation (RFR) standards welcomed the findings, saying they provide further justification for the government to take steps to better protect the public from cellphone radiation.

The expert panel recommended that the NTP upgrade carcinogenic confidence levels in March after a three-day meeting (TR Daily, March 29) to review two draft reports released in February on the results of research that exposed rats and mice to RFR for up to two years, or most of their life span (TR Daily, Feb. 2). The RFR exposure was intermittent – 10 minutes of exposure followed by 10 minutes without exposure – for about nine hours a day.

The NTP, an interagency program housed at the National Institute of Environmental Health Sciences, which is part of the National Institutes of Health, uses five levels of evidence of carcinogenic activity in its reports: Clear evidence, some evidence, equivocal evidence, no evidence, and inadequate study. The $30 million research study, which took more than a decade to complete, is the most comprehensive analysis on the health impacts to animals of RFR exposure.

The NTP’s draft report on rats concluded that there was “some evidence of carcinogenic activity” involving male rats and GSM and CDMA cellphone RFR “based on the incidences of malignant schwannoma in the heart.” Malignant schwannomas are a type of tumor. The 15-member peer-review panel said that those findings should be upgraded to “clear evidence.”

The peer-review panel also recommended that the level of evidence be upgraded from “equivocal evidence” to “some evidence” for malignant glioma of the brain in male rats (GSM and CDMA), and for pheochromocytoma (benign, malignant, complex) – an adrenal gland tumor – in male rats.

For female rats, the panel recommended upgrading from “no evidence” to “equivocal evidence” for malignant schwannoma of the heart (GSM and CDMA).

The levels of evidence for male and female mice remained at “equivocal” as in the draft report and in the recommendations of the expert panel.

The NTP accepted all of the panel’s recommendations.

“The exposures used in the studies cannot be compared directly to the exposure that humans experience when using a cell phone,” NTP senior scientist John Bucher said in a news release on the final reports. “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.”

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

“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,” the news release observed.

RFR levels ranged from 1.5-6 watts per kilogram in rats, and 2.5-10 watts per kilogram in mice. Under the current FCC standards, localized exposure for cellphones is limited to 1.6 watts per kilogram.

Mr. Bucher also emphasized that the research did not investigate 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 Michael Wyde, the lead toxicologist for the study.

“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,” according to the news release, a point echoed on a call that NTP officials held for reporters yesterday to discuss the final reports. “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.”

NTP scientists also noted that the research revealed an unexpected finding of longer life spans among male rats exposed to RFR. “This may be explained by an observed decrease in chronic kidney problems that are often the cause of death in older rats,” Mr. Wyde said.

Mr. Bucher said that the NTP has briefed the FCC and the Food and Drug Administration on the final findings of the research. The FDA nominated the cellphone RFR research for study by the NTP.

He also said that the NTP accepts the recommendations of expert peer-review panels “most of the time, if not all of the time,” and he emphasized the experts thoroughly evaluated the draft reports during the three-day meeting earlier this year.

The FCC in 2013 adopted an item opening a proceeding to explore whether it should modify its RF exposure standards (TR Daily, March 29, 2013). The review is the first time the FCC has considered whether to reexamine those standards since they were adopted in 1996. It has not taken action so far in the proceeding.

In response to the NTP’s findings, FCC spokesman Neil Grace said today, “I can’t say what the Commission might do on the RF standards proceeding. However, we are aware of the final study from the National Toxicology Program. Scientific evidence always informs FCC rules on these issues, and we will continue to follow all recommendations from federal health and safety experts. Therefore, I would refer you to the federal health experts at HHS and the FDA.”

In a lengthy statement, Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said his agency disagrees with the NTP’s conclusions “regarding ‘clear evidence’ of carcinogenic activity in rodents exposed to radiofrequency energy.”

He added that the NTP study “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. … We agree that these findings should not be applied to human cell phone usage.”

“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,” Mr. Shuren added. “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,” he stressed. “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,” the statement continued. “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 National Cancer Institute, which is also part of NIH, called the NTP study “thoughtfully designed and carefully controlled. However, the relevance of these findings to humans is not clear.

“The primary observations were for a rare cancer of Schwann cells in the heart and non-cancerous changes (hyperplasia) in the same tissues for male rats, but not female rats, nor in mice overall. From the perspective of human health, these findings are challenging to interpret because the results are inconsistent between mice and rats, and between male and female rats. Additionally, exposed animals lived longer than unexposed animals,” NCI noted.

“These experimental findings raise new questions as to the potential for radiofrequency radiation to result in cellular changes and offer potential avenues for further laboratory studies. Cancers in the heart are extremely rare in humans where the primary outcomes of potential concern with respect to radiofrequency radiation exposure from cell phones are tumors in the brain and central nervous system,” NCI continued. “The NCI experts noted that Schwann cells of the heart in rodents are similar to the kind of cells in humans that give rise to acoustic neuromas (also known as vestibular schwannomas), which some studies have suggested are increased in people who reported the heaviest use of cell phones. Additional investigation is needed to further address these questions.”

NCI added, “Often, when concerns are raised about exposures that may confer low-level risk for a rare cancer outcome — as is the case for cell phones and brain tumors — it takes time and many studies to come to any conclusions based on the weight of the evidence. Advances in mobile technologies have resulted in serial changes to both exposure and usage patterns, further complicating our ability to study possible risks. Experts at NCI monitor U.S. brain cancer incidence trends on a regular basis as part of their active engagement on the subject of potential health effects of radiofrequency (non-ionizing) radiation from cell phones. Even with frequent daily use by the vast majority of adults, we have not seen an increase in events like brain tumors.”

In a statement today, CTIA said, “The safety of consumers is the wireless industry’s first priority. We follow the guidance of experts when it comes to cellphones and health effects. The scientific community will consider today’s report in the context of the many scientific studies conducted over several decades. We note NTP’s own assessment that today’s report cannot be extrapolated to human cell phone usage, and the Food and Drug Administration’s concurrence that ‘these findings should not be applied to human cell phone usage’ and that ‘the existing safety limits for cell phones remain acceptable for protecting the public health.’ These conclusions are consistent with official federal brain tumor statistics showing that since the introduction of cellphones in the mid-1980s, the rate of brain tumors in the United States has decreased.”

Otis Brawley, chief medical and scientific officer for the American Cancer Society, said in an interview with TR Daily that the NTP study “was really the first radio frequency study to suggest that non-ionizing regulation like this could cause cancer.”

“It adds to our knowledge base,” he added, but he said that over decades of cellphone use, “we do not see an increase in the number of brain tumors in the human population. That’s the most important fact that I can quote in this entire cellphone discussion.”

“It gives scientists more information than it actually gives to the lay public,” Mr. Brawley said of the NTP research results. “We have some evidence that these radio frequency waves at very high energies can cause some tumors in mammals. That’s a big step from saying that these radio frequency waves at lower levels from cellphones cause brain tumors in humans.”

But advocates for tough RFR standards welcomed the final NTP findings, as they did the expert panel’s recommendations in March, and said they validate the importance of taking steps to protect the public from RFR from cellphones.

“More than a decade since it was first proposed, and after unprecedented reviews, the NTP has finally released a report confirming what hundreds of other studies have shown — namely that cell phone radiation levels we all encounter every day significantly increase malignant rare tumors of the brain and nerves as well as cause damage to the heart and DNA,” said Devra Davis, president of the Environmental Health Trust. “Were this any other modern agent, the appropriate regulatory agencies would be taking immediate action to reduce exposures. It is unconscionable that we continue to give millions (of children) the capacity to keep these cancer-increasing devices on their bodies all day or night. People have a right to know that phones are two way, microwave-radiating radios. The United States owes its citizens better.”

Ms. Davis said her group wants (1) the FDA to “perform a quantitative risk assessment to determine the levels of risk associated with this widespread exposure”; (2) industry to “launch a research and development program so that wireless devices emit the lowest amount of radiation as possible”; (3) the Environmental Protection Agency and other health agencies to “launch a full systematic and independent review of all scientific evidence”; and (4) policy actions and a public awareness campaign to protect the public.

Ronald Melnick, a senior adviser to the Environmental Health Trust who led the design of the NTP RFR testing, said, “One lesson learned from the NTP studies on cell phone radiofrequency radiation is that in the interest of public health it is not safe to assume that non-ionizing radiation cannot cause adverse health effects. Consequently, new wireless technologies, including 5G, should be adequately tested before their implementation leads to unacceptable levels of human exposures and increased health risks.”

“A quantitative risk assessment of the data from the NTP studies on cell phone radiofrequency radiation needs to be performed by the FDA and that information should be used by the FCC to develop health-protective exposure standards,” Mr. Melnick added.

“In my opinion, the National Toxicology Program studies provide conclusive evidence that long term exposure to cell phone radiation causes DNA damage and cancer,” said Joel Moskowitz, director of the Center for Family and Community Health at the School of Public Health at the University of California-Berkeley and creator of the saferemr.com web site. “The findings are similar to the results of the recent Ramazzini study.”

A study conducted by the Ramazzini Institute (RI) in Italy found the same type of tumors – malignant schwannomas – that were found in the NTP’s research (TR Daily, March 22). It was the world’s largest animal study on the impact of RFR.

Mr. Moskowitz said that the NTP and Ramazzini studies reaffirm concerns expressed in an International EMF appeal by hundreds of scientists seeking strengthened EMF guidelines (TR Daily, May 11, 2015).

Mr. Moskowitz also criticized the NTP for ignoring his “suggestion to conduct a formal analysis of the overall tumor rates for the final reports.”

Lisa Black, a spokeswoman for the American Academy of Pediatrics (AAP), said today that the group’s position on RFR from cellphones has not changed.

“Children are not little adults and are disproportionately impacted by all environmental exposures, including cell phone radiation,” the AAP said in comments filed with the FCC in its RF standards proceeding (TR Daily, Sept. 4, 2013). “Current FCC standards do not account for the unique vulnerability and use patterns specific to pregnant women and children. It is essential that any new standard for cell phones or other wireless devices be based on protecting the youngest and most vulnerable populations to ensure they are safeguarded throughout their lifetimes.”

“Clearly we need more studies that would be better indicative of what can happen in children with use of cell phones,” Jennifer Lowry, chair of the AAP’s Council on Environmental Health and chief of the Section of Toxicology and Environmental Health at Children’s Mercy Hospital in Kansas City, Mo., told TR Daily. “However, this study shows that we have a continued need to educate parents and children that they should limit screen time and not use cell phones or tablets as toys.” – Paul Kirby, paul.kirby@wolterskluwer.com

TR Daily – Nov. 1, 2018

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Reprinted with permission of TR Daily