Comments on the FCC’s Proposed Rule (Docket No. 19-226): “Human Exposure to Radiofrequency Electromagnetic Fields”
Submitted by Ronald Melnick, PhD
Senior Toxicologist, National Toxicology Program, National Institute of Environmental Health Sciences, now retired
I am submitting these comments to the FCC because I find that the proposed rule titled “Human Exposure to Radiofrequency Electromagnetic Fields,” which was published in the Federal Register (Vol. 85) on April 6, 2020, does not address adverse health effects that might occur at the radiofrequency (RF) exposure limits and at the expanded range of frequencies specified in the proposed rule. In my search of that document, I found no mention of ‘health effects’, ‘toxicity’, or ‘carcinogenicity’ associated with exposure to RF radiation despite the extensive scientific literature on these topics. With respect to public health considerations, I find it shocking that the FCC document lacks any discussion on how health effects of RF radiation, other than tissue heating, impacted the proposed rule. Surely, the FCC is aware of the numerous health effects studies at frequencies and modulations that have been used for wireless communication and that there are no adequate long-term health effects studies at frequencies above 6 GHz, which are included in the proposed rule.
The apparent basis for the FCC’s decision to ignore the health effects literature on RF radiation is the document “Commission’s Notice of Proposed Rulemaking” (NPRM) (Docket No. 19–226, adopted November 27, 2019 and released December 4, 2019) that was referenced in the section on Supplementary Information of the proposed rule. Interestingly, the December 4th release of the latter document indicated that the FCC would accept comments for “60 days from [its] publication in the Federal Register”. Since the NPRM was never published in the Federal Register and because it appears that that document served as the basis for the FCC’s decision to ignore concerns about potential health effects of RF radiation in the proposed rule, my comments provided below focus on the unreliable nature of the December 4th document.
The NPRM appears to have been written to support the FCC’s decision to retain the more than 20-year old standards for radiofrequency (RF) emissions; however, it is clear from the NPRM that the FCC has relied on a faulty narrative from the Food and Drug Administration (FDA) concerning health effects of RF radiation and in particular the utility of the National Toxicology Program (NTP) studies on cell phone radiation for assessing human health risks. Because I led the design of the NTP’s toxicity and carcinogenicity studies on cell phone RF radiation and was a senior toxicologist in the
NTP for more than 28 years, I feel compelled to address these issues so that the FCC will take into account potential health effects in their proposed rule on human exposure to RF radiation.
The FCC states in paragraph 11 of the NPRM that “no evidence has moved our sister health and safety agencies to issue substantive policy recommendations for strengthening RF exposure regulation. Indeed, the FDA maintains that “[t]he weight of scientific evidence has not linked cell phones with any health problems” and that “the current safety limits for cell phones are acceptable for protecting the public health.” “Accordingly, it is imprudent to revise these scientifically accepted recommendations….. especially when the FDA itself has found no evidence to support any revisions.” Without the FDA performing a quantitative risk assessment on available cancer data on cell phone radiation, it is inappropriate for the FCC to accept the FDA’s conclusion that “current safety limits for cell phones are acceptable for protecting the public health.”
Some background is needed to understand why it is wrong for the FCC to rely on the invalid comments by FDA. Ironically, it was the FDA that nominated 1 cell phone RF radiation emitted from wireless communication devices to the NTP. The FDA requested toxicity and carcinogenicity studies in experimental animals “to provide the basis to assess the risk to human health.” In making this nomination, the FDA was concerned that “existing exposure guidelines are based on protection from acute injury from thermal effects of RF radiation exposure, and may not be protective against any non- thermal effects of chronic exposures.” Thus, it is clear that FDA at that time believed that the NTP could conduct a reliable evaluation of potential health effects of RF radiation through animal experiments and that if any adverse effects were observed, then those data would be suitable to assess human health risks. To address the FDA’s request, the NTP conducted the largest and most expensive study on an agent ever nominated to this program.
Results from health effects studies in experimental animals are used by national and international health agencies (including the FDA) to assess human cancer risk for the following reasons; similar biological process of disease induction in animals and humans, exposures are well controlled in experimental studies thereby eliminating potential confounders, every known human carcinogen is carcinogenic in animals when adequately tested, and animal studies can eliminate the need to wait for sufficient human cancer data before implementing public health protective strategies. At the time that the NTP was developing its exposure methodology and experimental design, NTP scientists regarded previous and ongoing studies on cell phone RF radiation to be inadequate to test the prevailing assumption that cell phone RF radiation at non- or minimally thermal exposure intensities was incapable of inducing adverse health effects. For example, in most of these studies exposure durations were 2 hours or less per day, animal movement was restricted, and/or animals were not provided access to drinking water during exposures.
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.
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/).
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.
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.
2. NTP Toxicology and Carcinogenicity Studies of Cell Phone RF Radiation in Rats Cell Phone Radiation: GSM, Cell Phone Radiation: CDMA
3. Smith-Roe et al., Genotoxicity of Cell Phone Radiation in Rats and Mice
4. Peer Review of NTP Report on Cell Phone RF Radiation
5. Melnick 2019, Utility of NTP Study on Cell Phone Radiation for Assessing Human Health Risk
