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

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.

Keywords:

• Nonionizing electromagnetic fields
• radiofrequency fields
• genetic damage
• comet assay
• statistical methods

Author contributions

Dr. Vijayalaxmi performed the literature search and data compilations. Dr. Foster wrote the section on statistical analysis. Both authors read and approved the final manuscript.

Disclosure statement

Vijayalaxmi and Kenneth R. Foster declare no potential conflicts of interest. In the past, K. R. Foster has received minor levels of research funding from Mobile & Wireless Forum, an industry group.

Additional information

Funding

No outside source of funding was used to support this work.

Notes on contributors

Vijayalaxmi

Vijayalaxmi, Ph.D. is an Adjunct Faculty in the Department of Radiology, University of Texas Health Science Center, San Antonio, TX 78229, USA.

Kenneth R. Foster

Kenenth R. Foster, Ph.D. is Professor Emeritus of Bioengineering, University of Pennsylvania, Philadelphia PA 19041.