Bioelectromagnetics Supplement 6:S5^S6 (2003)

Reviews of Effects of RF Fields onVariousAspects of Human Health: Introduction{

C-K. Chou* and J.A. D’Andrea{

Co-Chairs of Subcommittee 4, International Committee onElectromagnetic Safety,Institute of Electrical and Electronics Engineers, Piscataway, NewJersey

The IEEE Standard for Safety Levels with Respectto Human Exposure to Radio Frequency Electromag-netic Fields, 3 kHz to 300 GHz, C95.1-1991, waspublished in 1991, reaffirmed in 1997, and amended in1999 with no changes in the exposure limits. A com-plete revision of the standard by the subcommittee weco-chair, now in progress, will be based on the peerreviewed literature identified by the Literature Surveil-lance Working Group.

More than 1300 relevant research papers havebeen evaluated by two randomly selected members ofthe subcommittee’s Engineering Evaluation WorkingGroup and by two members of the appropriateBiological EvaluationWorking Group (in vitro, in vivo,and epidemiology). Summaries of the working groupevaluations are forwarded to the Risk AssessmentWorking Group (RAWG) to evaluate the levels ofpossible risk to humans and define the lowest thresholdSAR above which potentially adverse effects are likelyto occur. A Mechanisms Working Group works inparallel with the RAWG to evaluate possible mechan-isms of interaction, both nonthermal and thermalmechanisms. In addition, review papers have beenprepared on cancer, reproduction, calcium efflux,behavior, thermoregulation, nervous system, ocularand auditory effects, homeostasis and metabolism,survival, epidemiology, and in vitro studies.

During the 2002 U.S. Air Force Research Lab-oratory Workshop ‘‘Setting a Science-Based Standardfor Safe Human Exposure to RF ElectromagneticFields: A Tribute to Dr. Eleanor R. Adair,’’ held inQuebec City, Que., Canada, 14 review papers werepresented to a large audience. These 14 papers werecommissioned by Subcommittee 4 (SC4) of the IEEEInternational Committee on Electromagnetic Safety(ICES) to assist with the Working Group’s assessmentof the extensiveRF bioeffect literature database. Exceptfor the epidemiology paper, each paper was writtenby SC4 members who were experts in the subjectmatter, and all subcommittee members were encour-aged to work with the lead authors. Dr. Mark Elwood,

an Australian epidemiologist, wrote the epidemiologypaper at the request of the Co-Chairs of SC4.

After the workshop, the available preliminarypapers were posted on the ICES SC4 public web-site (http://grouper.ieee.org/groups/scc28/sc4), solicit-ing comments prior to completion of the manuscripts.Thirteen papers were submitted to Bioelectromagneticsfor publication; 12 of these technical papers areincluded in this special issue. The subjects of the twopapers that are not included are calcium efflux and one-vs. two-tier standard. These two manuscripts mayappear in future regular issues of the Journal.

Some topics in the Literature Surveillance Work-ing Group database (posted on the ICES website http://grouper.ieee.org/groups/scc28/) are not covered in thisspecial issue. For example, electrostimulation by lowfrequencyRF current is not included.However, the finalpublished standard will include an ‘‘Informative Annex(Annex B)’’ that summarizes all topics covered in thedatabase. In addition to Annex B, Annex A describesthe approach adopted during the revision and Annex Cexplains the rationale of the revision. Other annexesinclude a bibliography and practical applications ofthe standard. The exposure limits are set forth in thenormative section of the standard.

At this writing, SC4 still has work to do tocomplete the revision of IEEE Standard C95.1-1991.On January 19, 2002, SC4 adopted 12 criteria to focus

Published 2003Wiley-Liss, Inc.{This article is a US government work, and, as such, isin the public domain in the United States of America.

——————*Correspondence to: C-K. Chou, Corporate EME ResearchLaboratory, Motorola Florida Research Laboratories, 8000 WestSunrise Blvd., Fort Lauderdale, FL 33322.E-mail: ck.chou@motorola.com

{J.A. D’Andrea’s permanent address is Naval Health ResearchCenter Detachment, Brooks City Base, TX.

Received for review 28 August 2003; Final revision received2 September 2003

DOI 10.1002/bem.10178Published online in Wiley InterScience (www.interscience.wiley.com).

the work of the subcommittee and help move therevision process forward. At that time, the literaturereview was ongoing and review papers were notcompleted. Therefore, based on our understanding atthat time and pending the conclusion of the literaturereview and the review paper process, the consensus ofthe Revision Working Group and SC4 was as follows.

1. The RF safety standard should be based on science.

2. RF safety standard revision should be derived from

peer reviewed publications and documents that are

reviewed by the SC4.

3. The adverse effect level remains at 4 W/kg subject to

revision following completion of the literature

evaluation and review papers.

4. The maximum exposure limits should be based on

established adverse effects after inclusion of an

appropriate safety factor(s).

5. Safety factor(s) should consider uncertainties in

the biological database (e.g., measurements, envir-

onmental conditions, exposure duration, individual

variability, and other factors.)

6. Nonthermal RF biological effects have not been

established and none of the reported nonthermal

effects are proven adverse to health (does not apply

to electrostimulation). Thermal effect is the only

established adverse effect.

7. The microwave hearing effect is not adverse and

should not be used for setting the peak power limit.

8. The shape and size of the averaging volume and the

peak SAR limit are still to be determined. The

important end point is the temperature change.

[During Revision Working Group meeting held on

September 9–10, 2002, ‘‘temperature change’’ was

revised to ‘‘absolute temperature.’’]

9. The RF standard should be harmonized with other

international standards to the extent where scientifi-

cally defensible.

10. Rationales must be documented for all changes

relative to the current standard.

11. The editorial committee will add in the informative

section a paragraph dealing with potentially sensitive

subpopulations, such as children.

12. Reconsider the two tier approach (whole body

average SAR 0.4 and 0.08 W/kg, the peak SAR

value and the averaging volume.

The above 12 criteria remain the guiding princi-ples of the revision. The first criterion is that thestandard must be based on science, and the RevisionWorking Group is committed to explaining the scien-tific rationale of the standard. Although all relevantbiological effect papers are reviewed, the emphasis ison adverse effects as stated in revision criterion #4. The

Revision Working Group defined an adverse effect as‘‘A biological effect characterized by a harmful changein health. For example, such changes can includeorganic disease, impaired mental function, behavioraldysfunction, reduced longevity, and defective or defi-cient reproduction.’’ In general, the ‘‘weight ofevidence’’ approach used by the National ToxicologyProgram, Environmental Protection Agency, and otherhealth and regulatory agencies world-wide is used inour review and assessment processes. The weight ofevidence approach was used to determine whether ornot an adverse effect has been established. An adverseeffect is considered ‘‘established’’ when there areconsistent findings published in peer reviewed scientificliterature from independent laboratories, and there isconsensus that the effect occurs for the specified ex-posure conditions. For safety standards setting, onlyestablished adverse effects should be considered.

As technology progresses, it is our duty asscientists and engineers to continually review andmonitor newfindings and to update and revise our safetystandards accordingly. In this issue, Osepchuk andPetersen describe how IEEE standards are developed.The process requires consensus of at least 75% of the122 members of SC4 and of the 109 members of theparent committee (after recirculation of negative ballotsto allow members to reconsider their original votes);this process will assure that the standard is the best wecan produce. The papers in this special issue providecomprehensive reviews of the biological effects ofexposure to radiofrequency energy. Based on this in-formation and other subjects summarized inAnnexBofthe forthcoming revised standard, ICES is committed tothe development of a science-based RF safety standardthat is protective of public health, unambiguous, andpractical to implement.

We would like to congratulate Dr. Eleanor Adairfor her distinguished contributions in Bioelectromag-netics and thank Dr. Michael Murphy for arranging forthe U.S. Air Force Research Laboratory for sponsoringthe Workshop and underwriting the publication costof this special issue. We would like to especiallythank the Editor in Chief of Bioelectromagnetics,Dr. Ben Greenebaum, for his great efforts in selectingthe reviewers to obtain balanced reviews and finalediting. We appreciate the anonymous reviewers fortheir valuable comments and suggestions to improvethe quality of these papers. The authors deserve around of applause for their voluntary time and effort towrite these extensive reviews. This special issue notonly serves in large measure as a scientific basis forthe IEEE C95.1 standard revision, but also will be avaluable reference on the subject for many years tocome.

S6 Chou and D’Andrea