Consequently, the NTP study was designed to challenge the assumption that RFR could not cause adverse health effects other than by tissue heating and to provide data on tissue dose and incidence of response that could be used to assess potential human health risks for any identified effects.

For the NTP chronic study, an exposure system was developed that enabled whole body exposures while animals were free roaming, had access to water during exposures, and that provided RF dosimetry in the brain at three levels: SAR = 1.5, 3.0, or 6 W/kg. These levels were selected based on results from preliminary thermal pilot and toxicity studies to ensure that these doses would not cause thermal injury. Because measured body temperatures were within 1 OC of their normal body temperature, there were no differences in body weights between exposed and sham control rats in the 2-year study, there was no indication of tissue damage in the 28-day study, and there were no exposure-related clinical observations in the 2-year study (NTP TR-595)2, it is clear that animals in the NTP study tolerated these exposure levels.

The NTP SAR exposure levels are similar to FCC’s local exposure limit for cell phone usage by the general population (SAR = 1.6 W/kg averaged over any one gram of tissue). The NTP levels are lower than FCC’s local limit for occupational exposures to RF radiation (SAR = 8 W/kg). If exposures to RF radiation in the NTP study had been limited to the FCC’s whole body exposure limit of 0.08 W/kg, then the brain and other organs would have been exposed to levels far below the FCC’s local exposure limit; data at that exposure level would be useless for assessing organ-specific human cancer risk because exposure to the brain of rats would have been 20-fold less than the FCC’s local limit for exposure to tissues such as the human brain.

The criticism that the RF levels were excessive is unfounded. Because of the limited power of an experimental study using 50 – 100 animals per exposure group to assess risk in the general population, it is unusual for such a study to only use doses in the range of permissible human exposures. In fact, exposures used in experimental carcinogenicity studies conducted by the NTP always include exposures that are greater than what most humans experience, and regulatory agencies including the FDA have used such data for nearly 40 years to extrapolate to ‘acceptable’ levels of human risk. Also, because animals were free roaming and had access to drinking water throughout the study, it was possible to increase the daily duration of exposure to 9 hr/day. While some may opine that this design does not represent most human exposures to RF radiation from use of cell phones (though most people carry their phones in the on-position on different parts of their bodies throughout the day), this comment is irrelevant since human risk assessments are based on the combination of exposure levels and duration of exposure.

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The NTP study found increased incidences of cancers and preneoplastic lesions in the heart and brain of rats, proliferative lesions in the rat prostate gland, DNA damage in brain cells of rats and mice (Smith-Roe et al., 2019)3, heart muscle disease in rats, and reduced rat birth weights. The results of the NTP study underwent an extensive (3-day) external peer review,4 and the peer-review panel concluded that the well-designed and well-conducted NTP study provided clear evidence of carcinogenic activity for heart schwannomas in male rats exposed to GSM and CDMA modulated RF radiation and some evidence of carcinogenic activity for brain gliomas in male rats. There were also small numbers of gliomas and heart schwannomas in exposed female rats but none in controls; the peer review panel concluded that there was equivocal evidence of carcinogenic activity for those tumors. The FCC’s current and proposed limits for RF radiation are based on the assumption that heating is the only way in which such exposures can cause adverse health effects. The results from the NTP studies demonstrate that this assumption is wrong.

It is also important to note that the cancers identified in the NTP study (heart schwannoma and brain glioma) involved the same cell types (Schwann cell and glial cell) for which an International Agency for Research on Cancer (IARC) expert working group found evidence of increased cancer risk among cell phone users and which served as the basis for the IARC conclusion in 2011that RF radiation was possibly carcinogenic to humans (https://www.ncbi.nlm.nih.gov/books/NBK304630/).

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After the FDA nominated cell phone RF radiation to the NTP for toxicity and carcinogenicity studies in experimental animals that could be used to provide the basis to assess the risk to human health and the NTP conducted a large and comprehensive study on cell phone RFR that an external peer-review panel concluded provided clear evidence of carcinogenic activity, Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health stated that the FDA disagrees with the conclusions of this carefully conducted, peer-reviewed study and that “these findings should not be applied to human cell phone usage.” At the time of the posting of the NPRM (December 4, 2019), the FDA had only provided online statements that lacked scientific documentation. In February 2020, the FDA released an anonymously written report titled “Review of Published Literature between 2008 and 2018 of Relevance to Radiofrequency Radiation and Cancer.” On February 27, 2020, I wrote a letter to Dr. Shuren (provided as an addendum to these comments) in which I noted numerous and serious flaws and inaccuracies in the FDA document, as well as omissions of relevant data from both mechanistic and epidemiological studies that indicate increased cancer risks associated with exposure to RF radiation. In an earlier publication, I addressed unfounded criticisms of the NTP study results (Melnick, 2019).5

The FDA needs to fulfill the intent of their nomination to the NTP and conduct a quantitative risk assessment so that the FCC can provide health-protective exposure standards. However, rather than providing a quantitative risk assessment of the NTP results, the FDA has dismissed the NTP findings, and without assessing human risk, arbitrarily claimed that “current safety limits for cell phones are acceptable for protecting the public health.” This recommendation by the FDA lacks scientific merit.

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It is certainly unusual for an agency such as the FDA to claim it is “protecting public health,” when it chooses to ignore adverse health effects data that committed to run counter to their preconceived notions. Consequently, for the FCC to rely on the unfounded claims of the FDA shows a lack of commitment by the FCC to protecting public health. I urge the FCC to reevaluate their RF exposure standards with full consideration of potential adverse health effects for the general population and for occupational exposures. At the expanded range of frequencies included in the proposed rule (i.e., above 2.5 GHz) there are no adequate long-term health effects studies. Thus, once again considerations for human safety are based on untested assumptions, yet we know from studies and experience with cell phone RF frequencies and modulations that assumptions of safety can be wrong. The general population and workers are entitled to know if there are potential health risks associated with exposures to these higher frequencies prior to the installation of 5G antennas in neighborhoods throughout the country. The determination of potential health risks or adequate safety can best be determined from properly conducted experimental studies. The alternative of waiting 20 to 30 years to learn whether exposures to 5G radiation increased disease rates in exposed human populations is not a wise public health strategy.

Ronald Melnick, PhD Comments on the FCC’s Proposed Rule on Human Exposure to Radiofrequency