The commenter critiques methods underlying ICNIRP and IEEE assessments and proposes criteria for evaluati…

This response addresses point 5 of the HHS remand in general, and 5.n in particular: “What scientific, technical, or regulatory changes by federal health agencies, if any, would improve the assessment, disclosure, and regulation of wireless radiation exposure.” Of particular concern are the assessments recommended by ICNIRP and IEEE ICES which underpin current exposure limits and will form the basis for future recommendations, as these assessments do not adequately meet reasonable scientific requirements, particularly when assessing studies investigating realistic RF-EMF exposures. Furthermore, these assessments apply requirements creating an in practice insurmountable evidentiary threshold before any non-thermal effect is given evidentiary weight, with serious consequences when setting exposure limits. This combination has so far produced conclusions of “no proof of risk”, which may be viewed as an artefact, i.e. produced by the assessments as such. Having studied this field for more than a decade, I have, together with scientific colleagues, developed a set of assessment criteria we consider necessary to improve the regulatory regime. These criteria aim to ensure that health risk assessments adequately consider studies investigating non-ionizing RF-EMF exposures below thermal levels, particularly under realistic exposure conditions, such as those encountered in everyday wireless communications. 1. Potential hazards and conclusions: Credible indications of potential harm must be identified and not disregarded due to a lack of full scientific certainty. All available evidence should be considered, and only excluded from the assessment based on scientific criteria such as serious flaws in the study design. 2. Distinguishing lack of evidence from evidence of no hazard: Insufficient evidence of harm must be distinguished from evidence that potential hazards are absent. 3. Transparent reporting: Evidentiary thresholds that reflect risk-management preferences must be explicitly identified. Risk-management preferences should not interfere with the risk-assessment. 4. Precautionary decisions: Credible indications of potential harm must be clearly reported, even when causation remains uncertain, to provide a scientific basis for considering preventive measures and their ethical, economic, and legal implications. 5. Exposure relevance and evidentiary weight: The relevance of the exposure characteristics to the target exposure scenario must be considered when assigning evidentiary weight to study findings, including findings of no effect. 6. Interpretation of exposure metrics: When assessing dose-response relationships, replication, and consistency across studies, the similarity of exposures must be evaluated using biologically relevant exposure characteristics, rather than assuming that similarity in a single exposure metric establishes biological equivalence. 7. Control-group exposure contrast: For hazard identification, exact dosimetry is not required, provided that it is reliably demonstrated that the exposed group is substantially more exposed than the control group. The exposure contrast must be sufficiently large and well characterized to support a meaningful comparison and minimize exposure misclassification. Assessments underlying the exposure limits recommended by ICNIRP and IEEE ICES do not fulfill these requirements, especially as to their handling of scientific uncertainty and the evidentiary weight they assign to studies investigating realistic RF/EMF exposures, while systematically assigning most evidentiary weight to studies with unrealistic exposures. Such methodological concerns also apply to other RF/EMF assessments based on ICNIRP and ICES theoretical foundations and methodologies, e.g. the European Commission's SCHEER opinion on RF/EMF health risks and the WHO systematic reviews prepared for its RF/EMF Environmental Health Criteria monograph. I recommend that HHS evaluate all scientific assessments intended to inform RF/EMF risk-management decisions against the proposed criteria before relying on their conclusions. The attached document, authored by five researchers who have studied and published scientific papers and books on the foundations of the current regulatory regime, provides the detailed reasoning behind these recommendations. It also forward references to methodologies suitable for assessing RF-EMF effects on human health in ways consistent with standard risk assessments for potentially toxic agents, as well as scientific literature establishing the scientific rationale for the proposed criteria. Else K. Nordhagen, Ph.D., Univ.of Oslo, Norway