Needed: More Reliable Bioeffects Studies at “High Band” 5G Frequencies

Abstract

One major source of controversy related to possible health effects of radiofrequency radiation (RFR) is the large number of reported statistically significant effects of exposure, over the entire RF part of the spectrum and over a wide range of exposure levels, even as health agencies do not find clear evidence for health hazards of exposure at levels within current IEEE and ICNIRP exposure limits. This Perspective considers 31 studies related to genetic damage produced by exposure to RFR at frequencies above 6 GHz, including at millimeter-wave (mm-wave) frequencies. Collectively, the papers report many statistically significant effects related to genetic damage, many at exposure levels below current exposure limits. However, application of five risk of bias (RoB) criteria and other considerations suggest that the studies in many cases are vulnerable to false discovery (nonreplicable results). The authors call for improvements in study design, analysis and reporting in future bioeffects research to provide more reliable information for health agencies and regulatory decision makers. This Perspective is a companion to another Perspective by Mattsson et al. elsewhere in this volume (Mattsson et al., 2021)1.

5G New Radio Requires the Best Possible Risk Assessment Studies: Perspective and Recommended Guidelines

“…However few if any RF bioeffects studies are done under GLP nor were they intended for submission to regulatory agencies as parts of new product/drug approval processes. All of the bioeffects studies reviewed by Simkó (2019), Wood et al, 2021, andVijayalaxmi andPrihoda (2019) are small and many were exploratory in nature, and many have high RoB. Such studies may open up interesting and fruitful scientific questions, but are prone to false discovery.…”

“…This Perspective is an extension of a companion Perspective in the same issue (Foster and Vijayalaxmi, 2021) which describes quality issues in one subset of studies involving RF radiation exposures above 6 GHz, involving assays of RF-induced genetic damage.…”

“…In particular, most if not all, RF bioeffects studies are not done under GLP, many have obvious design weaknesses and use statistical methodology that is known to be prone to false discovery (nonreplicable results). [For discussion of genetic toxicity studies see Foster and Vijayalaxmi (2021)].…”

“…While few of these studies are standardized risk studies (such as the National Toxicology Program (NTP) carcinogen screening assays (https://ntp.niehs.nih.gov/whatwestudy/testpgm/cartox/ index.html)], they address the biological effects of RF energy and would be carefully reviewed by health agencies. Unfortunately, many of the RF EMF bioeffects paper presently in the literature have insufficient quality to meet criteria for inclusion by health agencies (SSM, 2018) due to lack of appropriate exposure assessment, sham controls, blinding, or other study-design weaknesses (Simkó et al, 2016;Foster and Vijayalaxmi, 2021). Such papers can present unjustified claims that scare the public.…”

“…Since some level of systematic error might be present in any bioeffects study (even if very small), a sufficiently large study (large "n") can find statistically significant differences between the control and exposed groups due to residual errors in the experiment. In fact, RF bioeffect studies are often examining small apparent effects (e.g., Foster and Vijayalaxmi, 2021 for genetic damage studies) that can be difficult to separate from possible nonrandom errors.…”