Wednesday, September 1, 2021

WHO Radiofrequency EMF Health Risk Assessment Monograph (EHC series)

Sep 1, 2021 (Updated Sep 10, 2021)

The World Health Organization (WHO) is undertaking a health risk assessment of radiofrequency (RF) electromagnetic fields (EMF) which will be published as a monograph in the Environmental Health Criteria (EHC) series. This monograph will update the 1993 monograph on radiofrequency fields (EHC #197).

According to Microwave News, WHO originally began work on this monograph in 2012 and released 11 chapters of a draft report in 2014 for public comment. Comments on the draft report from other scientists were highly critical. "After that the process stalled, and the RF EHC was stuck in limbo." In October 2019, WHO issued a call for ten systematic reviews of the RF effects research (see list below). This call had a short timeline to apply. "The lack of advance notice and the fast deadline have led some to question whether the WHO engineered the schedule to help ICNIRP stay in control." In 2020, WHO reissued the call for three of these reviews (SR2, SR4, SR10).

Although WHO would not announce the scientists they chose to conduct these reviews, papers describing the research protocols for four of the new reviews were recently published (SR1 - Lagorio et al., 2021; SR4 - Pacchierotti et al., 2021; SR6 - Pophof et al., 2021; SR7 - Roosli et al., 2021; see abstracts below).

All of the research protocols will be published online for a special issue of Environment International (see https://www.sciencedirect.com/journal/environment-international/special-issue/109J1SL7CXT).

To conduct the research reviews, the scientists will use a "tailored version" of the National Toxicology Program's OHAT risk of bias rating tool "for evaluating individual study risk of bias or internal validity – the assessment of whether the design and conduct of a study compromised the credibility of the link between exposure and outcome" (1-3). This tool has been recommended for assessing risk of bias in human environmental epidemiology studies (Eick et al., 2021; see abstract below). 

For the EHC monograph, "Confidence in evidence will be assessed in line with the GRADE approach."

A tool is only as good as the persons using it. Will the scientists that the WHO chose to conduct these reviews apply these tools and approaches in an unbiased manner? Will they employ them to manufacture doubt about the validity of the thousands of peer-reviewed studies that assessed biologic and health effects from exposure to radio frequency fields?

Lagorio et al. (2021) while describing their research protocols forecast the conclusion of their review paper: "As systematic reviews cannot remedy limitations of the original studies, those (and our) syntheses are unlikely to produce conclusive evidence." So this review will likely call for more definitive research.

We should not forget there has never been a perfect study--every study has either limited internal validity and/or limited generalizability (external validity).

According to the National Research Council (2007):
"The extent to which particular scientific results constitute progress in knowledge or contribute to societal well-being is often contested. This is especially the case when scientific findings are uncertain or controversial and when they can be interpreted to support controversial policy choices....Assessing science, no matter how rigorous the methods that may be used, is ultimately a matter of interpretation. The possibility of competing interpretations of evidence is ever-present when using science indicators or applying any other analytic method for measuring the progress and impact of science." (4)

(1) National Toxicology Program. Handbook for Conducting Systematic Reviews for Health Effects Evaluations. https://ntp.niehs.nih.gov/whatwestudy/assessments/noncancer/handbook/index.html

(2) National Toxicology Program. Handbook for Conducting a Literature-Based Health Assessment Using OHAT Approach for Systematic Review and Evidence Integration (March 4, 2019): https://ntp.niehs.nih.gov/ntp/ohat/pubs/handbookmarch2019_508.pdf

(3) National Toxicology Program. 2019 OHAT Handbook Update and Clarification Summary Document (March 4, 2019). https://ntp.niehs.nih.gov/ntp/ohat/pubs/handbookclarificationmarch2019_508.pdf

(4) National Research Council. 2007. A Strategy for Assessing Science: Behavioral and Social Research on Aging. Washington, DC: The National Academies Press. https://doi.org/10.17226/11788.

Research Protocols for Radiofrequency EHC Reviews


SR1: The effect of exposure to radiofrequency fields on cancer risk in the general and working population: A protocol for a systematic review of human observational studies

Susanna Lagorio, Maria Blettner, Dan Baaken, Maria Feychting, Ken Karipidis, Tom Loney, Nicola Orsini, Martin Röösli, Marilia Silva Paulo, Mark Elwood. The effect of exposure to radiofrequency fields on cancer risk in the general and working population: A protocol for a systematic review of human observational studies. Environ Int. 2021 Aug 22;157:106828. doi: 10.1016/j.envint.2021.106828.

Highlights

• RF-EMF was classified by IARC as possibly carcinogenic to humans (2B) in May 2011
• A systematic review of all subject-relevant epidemiological studies is now needed.
• A detailed protocol ensures the review's transparency, utility and credibility.
• Original study validity will be evaluated with a customized OHAT risk of bias tool.
• Internal coherence and external plausibility will inform conclusions.

Abstract

Background: The World Health Organization (WHO) has an ongoing project to assess potential health effects of exposure to radiofrequency electromagnetic fields (RF-EMF) in the general and working population. Here we present the protocol for a systematic review of the scientific literature on cancer hazards from exposure to RF-EMF in humans, commissioned by the WHO as part of that project.

Objective: To assess the quality and strength of the evidence provided by human observational studies for a causal association between exposure to RF-EMF and risk of neoplastic diseases.

Eligibility criteria: We will include cohort and case-control studies investigating neoplasia risks in relation to three types of exposure to RF-EMF: near-field, head-localized, exposure from wireless phone use (SR-A); far-field, whole body, environmental exposure from fixed-site transmitters (SR-B); near/far-field occupational exposures from use of handheld transceivers or RF-emitting equipment in the workplace (SR-C). While no restriction on tumour type will be applied, we will focus on selected neoplasms of the central nervous system (brain, meninges, pituitary gland, acoustic nerve) and salivary gland tumours (SR-A); brain tumours and leukaemias (SR-B, SR-C).

Information sources: Eligible studies will be identified through Medline, Embase, and EMF-Portal.

Risk-of-bias assessment: We will use a tailored version of the OHAT's tool to evaluate the study's internal validity.

Data synthesis: We will consider separately studies on different tumours, neoplasm-specific risks from different exposure sources, and a given exposure-outcome pair in adults and children. When a quantitative synthesis of findings can be envisaged, the main aims of the meta-analysis will be to assess the strength of association and the shape of the exposure-response relationship; to quantify the degree of heterogeneity across studies; and explore the sources of inconsistency (if any). When a meta-analysis is judged inappropriate, we will perform a narrative synthesis, complemented by a structured tabulation of results and appropriate visual displays.

Evidence assessment: Confidence in evidence will be assessed in line with the GRADE approach.

Funding: This project is supported by the World Health Organization. Co-financing was provided by the New Zealand Ministry of Health; the Istituto Superiore di Sanità in its capacity as a WHO Collaborating Centre for Radiation and Health; ARPANSA as a WHO Collaborating Centre for Radiation Protection.

Registration: PROSPERO CRD42021236798.

Financial support 

This project is supported by the World Health Organization (grant numbers: RAD 2020/1031788–0; RAD 2020/994756–0). Co-financing was provided by the New Zealand Ministry of Health; the Istituto Superiore di Sanit`a in its capacity as a WHO Collaborating Centre for Radiation and Health; ARPANSA as a WHO Collaborating Centre for Radiation Protection.

Role of funders

A strict oversight was exercised by the WHO Secretariat to ensure that all commissioned systematic reviews were planned according to a harmonized and good practice standard. The other sponsors had no role in developing the protocol.

Open access paper: https://www.sciencedirect.com/science/article/pii/S0160412021004530?via%3Dihub

--

SR4: Effects of Radiofrequency Electromagnetic Field (RF-EMF) exposure on male fertility and pregnancy and birth outcomes: Protocols for a systematic review of experimental studies in non-human mammals and in human sperm exposed in vitro

Francesca Pacchierotti, Lucia Ardoino, Barbara Benassi, Claudia Consales, Eugenia Cordelli, Patrizia Eleuteri, Carmela Marino, Maurizio Sciortino, Martin H.Brinkworth, Guangdi Chen, James P. McNamee, Andrew William Wood, Carlijn R. Hooijmans. Rob B.M. de Vries. Effects of Radiofrequency Electromagnetic Field (RF-EMF) exposure on male fertility and pregnancy and birth outcomes: Protocols for a systematic review of experimental studies in non-human mammals and in human sperm exposed in vitro. Environment Int. Volume 157, December 2021, 106806.

Highlights

• Male infertility and adverse pregnancy outcomes are relevant human health problems.
• Radiofrequency electromagnetic fields are widespread in the human environment.
• A link between radiofrequency and adverse reproductive outcomes is controversial.
• This is the protocol of WHO-funded systematic review and meta-analysis on this issue.

Abstract

Background  Radiofrequency Electromagnetic Fields (RF-EMF) at environmental level have been reported to induce adverse effects on the male reproductive system and developing embryos. However, despite the number of experiments conducted since the 1970s, the diversity of testing approaches and exposure conditions, inconsistencies among results, and dosimetric flaws have not yet permitted a solid assessment of the relationship between RF-EMF exposure and such effects, warranting a more systematic and methodologically rigorous approach to the evaluation of available data.

Objectives  This study aims at evaluating the effects of RF-EMF exposure on male fertility and pregnancy outcomes by a systematic review (SR) of experimental studies, conducted in compliance with international guidelines. The evidence will be organized into three streams: 1) Studies evaluating the impact of RF-EMF on the male reproductive system of experimental mammals; 2) studies evaluating the impact of RF-EMF on human sperm exposed in vitro; 3) studies evaluating the impact of RF-EMF on adverse pregnancy, birth outcomes and delayed effects in experimental mammals exposed in utero.

Study eligibility and criteria  Eligible studies will include peer-reviewed articles reporting of original results about effects of controlled exposures to RF-EMF in the frequency range 100 kHz–300 GHz on the selected outcomes without any language or year-of-publication restrictions. Eligible studies will be retrieved by calibrated search strings applied to three electronic databases, PubMed, Scopus and EMF Portal and by manual search of the list of references of included papers and published reviews.

Study appraisal and synthesis method  The internal validity of the studies will be evaluated using the Risk of Bias (RoB) Rating Tool developed by National Toxicology Program/Office of Health Assessment and Translation (NTP/OHAT) integrated with input from the SYRCLE RoB tool. Given sufficient commensurate data, meta-analyses will be performed, otherwise narrative syntheses will be produced. Finally, the certainty of the effects of RF-EMF exposure on male fertility and pregnancy and birth outcomes will be established following GRADE.

Funding  The study is financially supported by the World Health Organization.

Registration  OSF Registration DOI https://doi.org/10.17605/OSF.IO/7MUS3; PROSPERO CRD42021227729, CRD42021227746.

Financial support

This project is partially funded by the World Health Organization (contract 2020/1026306-0). Additional in-kind funds are provided by ENEA, Health Canada and Swinburne University of Technology.

Declaration of Competing Interest

AWW directs a research group, which includes three technical associates who are telecommunications company employees. The group is also providing advice for a local government authority and a utility on electric and magnetic field exposure issues on a fee-for-service basis. AWW has been member of the ICNIRP Scientific Expert Group (SEG) from 2013 until 2021 and collaborates with the Australian Radiation Protection and Nuclear Safety Agency. JPM was a member for IARC Monograph 102 Working Group assessing the carcinogenicity of RF-EMF (Mechanistic Studies sub-group), a co-author of Canada’s Safety Code 6 (which are the de facto national human exposure limits applied in Canada) and a member of the WHO EMF Project International Advisory Committee (Canadian representative). Health Canada financially contributed to the WHO EMF Project to support the completion of the systematic reviews on RF-EMF. CM has been member of Technical Consultation on the WHO RF Research Agenda (2010), member of ICNIRP main commission since May 2012, confirmed in 2016 and 2020, Italian delegate for the European Cost Actions BM0704 and BM1309 “EMF-MED”. All other authors declare that they have no known conflicts of interest.


--

SR6: The effect of exposure to radiofrequency electromagnetic fields on cognitive performance in human experimental studies: A protocol for a systematic review

Blanka Pophof, Jacob Burns, Heidi Danker-Hopfe, Hans Dorn, Cornelia Egblomassé-Roidl, Torsten Eggert, Kateryna Fuks, Bernd Henschenmacher, Jens Kuhne, Cornelia Sauter, Gernot Schmid. The effect of exposure to radiofrequency electromagnetic fields on cognitive performance in human experimental studies: A protocol for a systematic review. Environ Int. 2021 Jul 29;157:106783. doi: 10.1016/j.envint.2021.106783.

Abstract

Background: The World Health Organization (WHO) is currently assessing the potential health effects of exposure to radiofrequency electromagnetic fields (RF-EMFs) in the general and working population. Related to one such health effect, there is a concern that RF-EMFs may affect cognitive performance in humans. The systematic review (SR) aims to identify, summarize and synthesize the evidence base related to this question. Here, we present the protocol for the planned SR.

Objectives: The main objective is to present a protocol for a SR which will evaluate the associations between short-term exposure to RF-EMFs and cognitive performance in human experimental studies.

Data sources: We will search the following databases: PubMed, Embase, Web of Science, Scopus, and the EMF-Portal. The reference lists of included studies and retrieved review articles will be manually searched.

Study eligibility and criteria: We will include randomized human experimental studies that assess the effects of RF-EMFs on cognitive performance compared to no exposure or lower exposure. We will include peer-reviewed articles of any publication date in any language that report primary data.

Data extraction and analysis: Data will be extracted according to a pre-defined set of forms developed and piloted by the review author team. To assess the risk of bias, we will apply the Rating Tool for Human and Animal Studies developed by NTP/OHAT, supplemented with additional questions relevant for cross-over studies. Where sufficiently similar studies are identified (e.g. the heterogeneity concerning population, exposure and outcome is low and the studies can be combined), we will conduct random-effects meta-analysis; otherwise, we will conduct a narrative synthesis.

Assessment of certainty of evidence: The certainty of evidence for each identified outcome will be assessed according to Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Performing the review according to this protocol will allow the identification of possible effects of RF-EMFs on cognitive performance in humans. The protocol has been registered in PROSPERO, an open-source protocol registration system, to foster transparency.

Financial support

This project is funded by the World Health Organization.

Registration

PROSPERO CRD42021236168.

Declaration of Competing Interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Open access paper: https://www.sciencedirect.com/science/article/pii/S0160412021004086?via%3Dihub

--

SR7: The effects of radiofrequency electromagnetic fields exposure on tinnitus, migraine and non-specific symptoms in the general and working population: A protocol for a systematic review on human observational studies

Martin Röösli, Stefan Dongus, Hamed Jalilian, Maria Feychting, John Eyers, Ekpereonne Esu, Chioma Moses Oringanje, Martin Meremikwu, Xavier Bosch-Capblanch. The effects of radiofrequency electromagnetic fields exposure on tinnitus, migraine and non-specific symptoms in the general and working population: A protocol for a systematic review on human observational studies. Environment International, Volume 157, 2021. doi: 10.1016/j.envint.2021.106852.

Highlights

• There is public concern to develop non-specific symptoms from EMF.
• No up to date comprehensive systematic review is available.
• Priority outcomes for head exposure are tinnitus, migraine, and headaches.
• Further priority outcomes are sleep disturbances and composite symptom scores.

Abstract

Background  Applications emitting radiofrequency electromagnetic fields (RF-EMF; 100 kHz to 300 GHz) are widely used for communication (e.g. mobile phones), in medicine (diathermy) and in industry (RF heaters). Concern has been raised that RF-EMF exposure affects health related quality of life, because a part of the population reports to experience a variety of symptoms related to low exposure levels below regulatory limits.

Objectives  To systematically review the effects of longer-term or repeated local and whole human body RF-EMF exposure on the occurrence of symptoms evaluating migraine, tinnitus, headaches, sleep disturbances and composite symptom scores as primary outcomes.

Methods  We will follow the WHO handbook for guideline development. For the development of the systematic review protocol we considered handbook for conducting systematic reviews for health effects evaluations from the National Toxicology Program-Office of Health Assessment and Translation (NTP-OHAT) and COSTER (Recommendations for the conduct of systematic reviews in toxicology and environmental health research).

Eligibility criteria  Peer-reviewed epidemiological studies in the general population or workers aiming to investigate the association between local or whole-body RF-EMF exposure for at least one week and symptoms are eligible for inclusion. Only cohort, case-control and panel studies will be included.

Information sources  We will search the scientific literature databases Medline, Web of Science, PsycInfo, Cochrane Library, Epistemonikos and Embase, using a predefined search strategy. This search will be supplemented by a search in the EMF-Portal and checks of reference lists of relevant papers and reviews.

Study appraisal and synthesis method  Data from included papers will be extracted according to predefined forms. Findings will be summarized in tables, graphical displays and in a narrative synthesis of the available evidence, complemented with meta-analyses. We will separately review effects of local, far field and occupational exposure.

Risk of bias The internal validity of included studies will be assessed using the NTP-OHAT Risk of Bias Rating Tool for Human and Animal Studies, elaborated to observational RF-EMF studies.

Evidence appraisal  To rate certainty of the evidence, we will use the OHAT GRADE-based approach for epidemiological studies.

Framework and funding  This protocol concerns one of the ten different systematic reviews considered in a larger systematic review of the World Health Organization to assess potential health effects of exposure to RF-EMF in the general and working population.

Registration PROSPERO CRD42021239432.

Open access paper: https://www.sciencedirect.com/science/article/pii/S0160412021004773?via%3Dihub

--

Prioritizing health outcomes when assessing the effects of exposure to radiofrequency electromagnetic fields: A survey among experts

Jos Verbeek, Gunnhild Oftedal, Maria Feychting, Eric van Rongen, Maria Rosaria Scarfì, Simon Mann, Rachel Wong, Emilie van Deventer. Prioritizing health outcomes when assessing the effects of exposure to radiofrequency electromagnetic fields: A survey among experts. Environment International. Volume 146, 2021. 106300. 
doi:10.1016/j.envint.2020.106300.

Highlights

• RF EMF may lead to other than heat-related health effects by yet unknown mechanisms
• Prioritizing health effects is needed for review utility and resource efficiency.
• RF EMF experts prioritized all peer-reviewed published biological and health outcomes.
• Cancer, heat-related effects, and adverse birth outcomes were rated most critical.
• WHO commissioned ten systematic reviews of the most critical health outcomes.

Abstract

Exposure to radiofrequency (RF) electromagnetic fields (EMF) (frequencies of 100 kHz to 300 GHz) has been steadily increasing. In addition to heat-related effects of RF EMF, other yet-unspecified biological effects, might exist which could possibly lead to health effects. Given the large number of health endpoints that have been studied, we wanted to prioritize those that would merit systematic reviews.

We developed a survey listing of all health endpoints reported in the literature and we asked 300 RF EMF experts and researchers to prioritize these health effects for systematic review as critical, important or unimportant. We also asked the experts to provide the rationale for their prioritization.

Of the 300 RF EMF experts queried, 164 (54%) responded. They rated cancer, heat-related effects, adverse birth outcomes, electromagnetic hypersensitivity, cognitive impairment, adverse pregnancy outcomes and oxidative stress as outcomes most critical regarding RF EMF exposure. For these outcomes, systematic reviews are needed. For heat-related outcomes, the experts based their ranking of the critical outcomes on what is known from human or animal studies, and for cancer and other outcomes, they based their rating also on public concern.

To assess health risks of an exposure in a robust manner, it is important to prioritize the health outcomes that should be systematically reviewed. Here we have shown that it feasible to do so in an inclusive and transparent way.

Excerpts

Given the limited resources available for systematic reviews, it was decided to include male fertility but not brain electrical function. The ratings of these two outcomes as critical were similar, but more experts rated male fertility as important....

Declaration of Competing Interest

MF was vice chairman (May 2016 – May 2020) of the International Commission on Non-Ionizing Radiation Protection, an independent body setting guidelines for non-ionizing radiation protection. She has served as advisor to several national and international public advisory and research steering groups concerning the potential health effects of exposure to non-ionizing radiation.

MRS is in the Scientific Council of the Swedish Radiation Safety Authority for preparing reports on the evaluation of the scientific literature related to electromagnetic fields and health.

GO is member of the International Commission on Non-Ionizing Radiation Protection. She has been member of groups appointed by Norwegian authorities to evaluate potential health effects of non-ionizing electromagnetic fields.

EvR was chairman (May 2016 – May 2020) of the International Commission on Non-Ionizing Radiation Protection and is currently vice-chairman. He is also member of the Scientific Council of the Swedish Radiation Safety Authority.

SM is a member of the International Commission on Non-Ionizing Radiation Protection’s Scientific Expert Group. Within the UK, he is Secretary to the Committee on Medical Aspects of Radiation in the Environment and he was Secretary (until 2017) to the Advisory Group on Non-Ionising Radiation.

All other authors have declared no conflict of interest.


--

Assessing risk of bias in human environmental epidemiology studies using three tools: different conclusions from different tools

Stephanie M. Eick, Dana E. Goin, Nicholas Chartres, Juleen Lam, Tracey J. Woodruff. Assessing risk of bias in human environmental epidemiology studies using three tools: different conclusions from different tools. Syst Rev 9, 249 (2020). doi: 10.1186/s13643-020-01490-8.

Abstract

Background  Systematic reviews are increasingly prevalent in environmental health due to their ability to synthesize evidence while reducing bias. Different systematic review methods have been developed by the US National Toxicology Program’s Office of Health Assessment and Translation (OHAT), the US Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS), and by the US EPA under the Toxic Substances Control Act (TSCA), including the approach to assess risk of bias (ROB), one of the most vital steps which is used to evaluate internal validity of the studies. Our objective was to compare the performance of three tools (OHAT, IRIS, TSCA) in assessing ROB.

Methods  We selected a systematic review on polybrominated diphenyl ethers and intelligence quotient and/or attention deficit hyperactivity disorder because it had been endorsed by the National Academy of Sciences. Two reviewers followed verbatim instructions from the tools and independently applied each tool to assess ROB in 15 studies previously identified. We documented the time to apply each tool and the impact the ROB ratings for each tool had on the final rating of the quality of the overall body of evidence.

Results  The time to complete the ROB assessments varied widely (mean = 20, 32, and 40 min per study for the OHAT, IRIS, and TSCA tools, respectively). All studies were rated overall “low” or “uninformative” using IRIS, due to “deficient” or “critically deficient” ratings in one or two domains. Similarly, all studies were rated “unacceptable” using the TSCA tool because of one “unacceptable” rating in a metric related to statistical power. Approximately half of the studies had “low” or “probably low ROB” ratings across all domains with the OHAT and Navigation Guide tools.

Conclusions  Tools that use overall ROB or study quality ratings, such as IRIS and TSCA, may reduce the available evidence to assess the harms of environmental exposures by erroneously excluding studies, which leads to inaccurate conclusions about the quality of the body of evidence. We recommend using ROB tools that circumvent these issues, such as OHAT and Navigation Guide.