The need for consensus guidelines to address the mixed legacy of genetic damage assessments for radiofrequency fields

Abstract

The need for consensus guidelines to address the mixed legacy of genetic damage assessments for radiofrequency fields Vijayalaxmi, Foster KR. The need for consensus guidelines to address the mixed legacy of genetic damage assessments for radiofrequency fields. Int J Radiat Biol. 2023 Apr 10:1-11. doi: 10.1080/09553002.2023.2188936. Abstract Purpose: This review considers issues related to interpreting the mixed legacy of >300 papers published during the past three decades on possible genotoxic effects of exposure of human and animal tissues to radiofrequency electromagnetic fields (RF-EMF). The main paper reviews the evolution of consensus guidelines for genotoxicity testing and the increasing emphasis on systematic reviews for evaluation of scientific studies for use in health risk assessments. An Appendix considers some issues in assessing the bioeffects literature by examining a subset of genotoxicity publications that employed the comet assay. While most studies found no statistically significant effects of exposure, a significant minority of studies (chiefly, in vivo studies) reported statistically significant effects of exposure. The quality of the studies was highly variable; while several studies were meticulously done and documented, none of these studies were compliant with currently accepted guidelines such as those of the Organization for Economic Cooperation and Development (OECD). Evaluation of the studies using risk of bias (RoB) criteria showed that, in this sample of studies, higher quality studies were less likely to find statistically significant results than those of lower quality. Conclusion: The authors conclude that statistical significance should be only one consideration in evaluation of bioeffects studies. Simply listing 'statistically' significant effects identified using null hypothesis testing and the criterion p < 0.05 for statistical significance is misleading and uninformative in assessing health risks of exposure. A careful synthesis of evidence is needed, including assessment of study validity, biological significance of reported effects, and coherence of study results with those of other related studies.The authors recommend that all future RF genotoxicity studies intended for use in human health risk assessments and evaluations of the literature should be done in compliance with accepted quality guidelines, i.e. OECD or equivalent guidelines for genotoxicity screening studies and PRISMA or other accepted guideline for reviews of the literature. The positive studies in this group should be redone with tighter quality control to establish the reliability of the findings. pubmed.ncbi.nlm.nih.gov Excerpts From 1990 to 2020, more than 300 genetic damage studies have been reported (Table1) and the literature has been repeatedly reviewed (Table 2).This work, by many investigators in many different coun-tries, has led to an extensive but highly inconsistent body of studies, both with respect to quality of studies and the results themselves.... Reviews that evaluated the strength of evidence for genotoxic effects of RF-EMF and considered study validity and consistency of results across studies have found the evidence for genotoxic effects of RFexposure at‘nonthermal’ (not producing damaging heating) levels of exposure to be mixed and overall unpersuasive (Brusick et al.1998; Verschaeve and Maes1998; Vijayalaxmi and Prihoda 2008, 2012, 2019; Verschaeve 2009; Verschaeve et al. 2010). Other, less critical, reviews have concluded that RF-EMF exposure causes genetic damage (Ruediger 2009; Lai 2021) (Table 3).... Many or most RF-EMF genotoxicity studies reported to date have generally followed protocols published in scientific papers, but lacked the rigorous quality control measures that are typically employed in studies done for regulatory pur-poses. In recent years, largely after the reviews cited inTable 3were completed, the standards for conduct and evaluation of science have been raised, particularly for stud-ies to be considered in health risk assessments.... Much of the public debate about safety of RF-EMF energy turns on the many reports of statistically significant effect of exposure. Indeed, a large fraction if not the majority of all RF bioeffects studies report statistically significant effects of exposure over all frequency ranges and exposure levels examined, which gives the impression of biological activity of RF-EMF at all frequencies and exposure levels.Most of these reported effects were identified using null hypothesis significance testing (NHST) and the criterion p<0.05 - despite repeated warnings by statisticians of the limitations of this approach for scientific inferences (Wasserstein and Lazar 2016).... In contrast to some commentators on the RF-EMF literature that list many statistically significant results of RF- EMF bioef-fects studies, expert groups have stressed the need to go beyond statistical significance and synthesize and critically review the evidence. For example, the [European Commission] Scientific Committee on Health, Environmental and EmergingRisks (SCHEER 2018) outlines key issues to be evaluated when reviewing the literature. These include • Characterization of the stressor • Soundness and appropriateness of the methodology and models • Extent to which the full details of methodology are provided • Reproducibility of findings between experiments/observations • Relevance of a set of data for a particular endpoint. For genotoxic screening studies, OECD guidelines provide much more detailed advice aimed at achieving these broadly stated objectives. In 2016 the American Statistical Association published a statement that expresses the caution of statisticians about NHST and p-value (Wasserstein and Lazar 2016): ...A conclusion does not immediately become true on one side of the divide [of statistical significance] and false on the other. Researchers should bring many contextual factors intoplay to derive scientific inferences, including the design of study, the quality of the measurements, the external evidence for the phenomenon under study, and the validity of assumptions that underlie the data analysis. The statistically significant increases in genetic damage,albeit with modest effect size, in several invivo studies is striking. Perhaps invivo studies simply present more opportunities for experimental error than invitro studies, or perhaps something more interesting is occurring. These studies should be redone with more rigorous quality controls, i.e.complaint with OECD guidelines. There is no point in doing studies that are intended to inform health risk assessments that do not meet current standards of quality. Simply listing statistically significant results without an appropriate evaluation of study quality and synthesis of evidence across related studies is neither reliable nor informative tandfonline.com

AI evidence extraction

Main findings

This review summarizes >300 RF-EMF genotoxicity papers over three decades and reports that most studies found no statistically significant effects, while a significant minority (chiefly in vivo) reported statistically significant genetic damage. Study quality was highly variable and none of the reviewed studies were compliant with current OECD genotoxicity testing guidelines; in a subset evaluated with risk-of-bias criteria, higher-quality studies were less likely to report statistically significant effects than lower-quality studies.

Outcomes measured

• Genotoxic effects / genetic damage
• Comet assay endpoints (subset discussed)
• Study quality / risk of bias (RoB) assessments
• Statistical significance reporting (p<0.05; NHST) in RF-EMF bioeffects literature

Limitations

• No specific RF exposure parameters (frequency, SAR, duration, sources) are provided in the abstract.
• The paper is a narrative review; methods for literature search/selection are not described in the abstract.
• Risk-of-bias evaluation is described for a subset (comet assay publications), not necessarily the full literature.

Suggested hubs

• who-icnirp (0.32)
  Discusses health risk assessment context and consensus guideline approaches for evaluating RF-EMF bioeffects literature.

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    "population": "Human and animal tissues (in vivo and in vitro studies discussed)",
    "sample_size": null,
    "outcomes": [
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        "Comet assay endpoints (subset discussed)",
        "Study quality / risk of bias (RoB) assessments",
        "Statistical significance reporting (p<0.05; NHST) in RF-EMF bioeffects literature"
    ],
    "main_findings": "This review summarizes >300 RF-EMF genotoxicity papers over three decades and reports that most studies found no statistically significant effects, while a significant minority (chiefly in vivo) reported statistically significant genetic damage. Study quality was highly variable and none of the reviewed studies were compliant with current OECD genotoxicity testing guidelines; in a subset evaluated with risk-of-bias criteria, higher-quality studies were less likely to report statistically significant effects than lower-quality studies.",
    "effect_direction": "mixed",
    "limitations": [
        "No specific RF exposure parameters (frequency, SAR, duration, sources) are provided in the abstract.",
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