ICES International Committee on Electromagnetic Safety Unapproved Minutes TC95 Committee (Safety Levels with Respect to Human Exposure to Electric, Magnetic and Electromagnetic Fields, 0 Hz to 300 GHz 1300 – 1700 Tuesday, 12 January 2016 Motorola Solutions 8000 West Sunrise Blvd Plantation, FL 33322 1. Call to Order The meeting was called to order at 1235 h. 2. Introduction of those Present Each of the attendees introduced her/himself. (See Attachment 1 for the list of attendees.) 3. Approval of Agenda Following a motion by Hatfield that was seconded by Keshvari, the agenda was approved as presented. (See Attachment 2.) 4. Approval of June 13, 2015 TC95 Minutes Following a motion by Ziskin that was seconded by Hirata, the minutes of the June 2015 TC95 meeting were approved as presented. 5. ICES Chairman’s Report Bodemann provided a brief update on the low frequency EMF regulations/program in Germany (see Attachment 3). The goal of the program is to reduce exposures to as low as possible levels. In response to a question regarding determination of compliance, Bodemann explained how that decision will be made by the inspectors. Assuring compliance will be the responsibility of the owner/operator. Also, guidance or action levels will not be included—decisions will be left to the “authorities.” Bodemann briefly discussed the national transposition of Directive 2013/35/EU (electromagnetic fields, 0 Hz to 300 GHz) noting that EU members have to bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 July 2016. He also noted that a workshop/meeting is being planned around the time of BioEM2016 where key people from the Commissions will be invited to discuss harmonization of standards internationally. He will inform the committee when more information is available. Bodemann congratulated Reilly for receiving the 2015 IEEE SA International Award “for significant contributions in electrostimulation research and its application in harmonization of international safety standards for exposure of humans to low-frequency electric and magnetic fields.” All enthusiastically agreed that Reilly certainly deserved the recognition. It also was announced that Thanh Dovan, who cochaired SC3 for more than 13 years, has retired from the company where he worked and will stepping down as Co-Chairman of SC3. Thanh was called to the podium and presented a plaque to express the committee’s appreciation for his efforts and support over the years. Unapproved Minutes – 12 January 2016 TC95 Meeting 6. TC95 Chairman’s Report Chou reviewed his efforts to promote the ICES scope – “Promoting the safe use of electromagnetic energy.” (See Attachment 4.) Included in his presentation was an announcement that on 26 November 2015, IEEE Std C95.1-2345-2014 was adopted as the replacement for NATO Standards Agreement (STANAG) 2345—he thanked Klauenberg for his tireless efforts in making this happen. Chou briefly reviewed presentations given at a number of meetings. He noted that the WHO EMF Project initiative to move forward with a single international standard is now on hold due to budgetary constraints. However, he is optimistic that under ICNIRP’s new leadership (Eric von Rongen), and the appointment of Akimasa Hirata (Chairman of TC95 SC6) to ICNIRP, the prospect of increased collaboration between ICES and ICNIRP will be enhanced. Both groups recognize that the way forward to a single science-based international standard is collaboration – not competition. 7. Executive Secretary’s Report Petersen presented the Executive Secretary’s Report (Attachment 5). He noted that the PARs for the revision of IEEE Std C95.1-2005 and C95.3-2002 expire 31 December 2016—extension requests will have to be submitted no later than 17 October in order to keep the projects alive. It was also noted that the PAR for the revision of IEEE Std C95.2-1999 expired 31 December 2014. The statistics for the GetProgram for C95 standards was briefly discussed. Of note was the total number of standards downloaded over the past four years – 12, 687. Petersen concluded by pointing out that in order to participate in sponsor balloting of IEEE standards, one must be a member of the IEEE SA. He noted that before draft standards are submitted to IEEE for sponsor ballot, they are balloted at the TC95 level following the same rigorous process as that of IEEE sponsor ballot process. Therefore, TC95 members and members of the TC95 SCs and WGs who are not IEEE-SA members but desire to vote on a standard should join the TC/SC/WG ballot groups. 8. Treasurer’s Report Petersen presented the Treasurer’s Report (Attachment 6). He noted that as of 31 December 2015 the balance in the ICES TC95 account was $17,497.62. Income and expenses for this meeting should not change the balance appreciably. 9. Membership Chairman’s Report Membership Committee Chairman Klauenberg presented the Membership Committee Report (see Attachment 7). He welcomed the new members, two of whom were present at this meeting. He also reviewed the current list of members noting that TC95 currently has members from 27 countries. Klauenberg pointed out that some members were inactive and could be dropped from membership and explained how each year those who have not actively participated are contacted to determine interest in maintaining official membership on TC95. Those failing to respond are dropped from membership. He reviewed some of the benefits of TC95 membership, including access to protected sections of the ICES website, voting on committee issues at meetings and on draft standards (by e-mail), and participating in balloting on ICES standards subject to IEEE rules. He pointed out that anyone attending this meeting who is interested in joining TC95 should contact him at bertram.klauenberg@us.af.mil, and concluded by reviewing TC95 membership requirements, i.e., participation, participation, participation. 10. Topic presentations a) IEC TC106/IEEE TC 34 Update Keshvari discussed the scope of the SCC39 TC34 subcommittees and working groups (Attachment 8). He noted that many of the TC34 members are also members of those IEC TC106 Project and Maintenance Teams with scopes similar to those of the TC34 SCs and WGs. He reviewed changes in the TC 106 leadership – Mike Woods (AU) replaces Ron Petersen (US) as Chairman and Mathias Meier (DE) replaces Thomas Fischer (DE). He also noted that the final draft international standard (FDIS) IEC P62209-1 (SAR measurement in the head), which is essentially analogous to IEEE Std Unapproved Minutes – 12 January 2016 TC95 Meeting 1528-2013, will be distributed sometime during the next three months. Combining P62209-1 with P62209-2 (SAR in the body) into a single standard is also progressing. Because of the similarity between the IEC and IEEE standards, consideration is being given to combining the two IEC projects with the IEEE equivalent into a single a dual logo standard, as was done for the four numerical standards P62704-1 through 4. He also noted that consideration is being given to combining P62704-1 (general FDTD methods) and P62704-4 (finite element method). Keshvari concluded by noting that the P62232 (determination of RF field strength and SAR in the vicinity of radio-communication base stations) committee draft for vote should be distributed for comment in May 2016. b) Transcranial Direct Current Stimulation Bikson’s presentation focused on the wide use of non-invasive electrical stimulation devices for medical and neuro-enhancement purposes (Attachment 9). He pointed out that a concern is that large numbers of these devices are widely used and some may be dangerous. Many lack warning labels, timers and other safety features, i.e., there are no regulatory standards. In response to a question from Meltz, Bikson replied that he is asking ICES to consider developing a standard that could be followed by manufacturers, e.g., providing limits and protocols for warning labels and timers. He expected responsible manufacturers to welcome such a standard and noted that federal agencies might also have interest in such a standard, e.g., as the basis for federal regulations. He noted that the FDA is already looking into issues relating to electronic muscle stimulators. One concern is that many of the devices are available to almost anyone from a number of companies that claim they do not manufacture medical devices. Moreover, there is a paucity of clinical trials regarding effectiveness. In order to move forward, it was agreed that Bikson would draft a recommendation to the AdCom specifying the possible role of ICES in addressing concerns relating to these devices. ACTION ITEM 1: Bikson to prepare a document for consideration by the ICES AdCom pointing out concerns associated with the use of transcranial direct current stimulation devices and what the specific role of ICES should be in addressing these concerns. Chou, Kavet and Ziskin will participate. c) Why are most experimental findings false? Ziskin provided a brief presentation on the false discovery rate and misinterpretation of p-values – specifically, that conclusion that an effect occurs in a controlled study if the p value is < 0.05 (see Attachment 10). He described how the conclusion that a statistical analysis of the difference between groups in a controlled experiment that shows that p < 0.05 demonstrates an effect in many cases is incorrect. Summary conclusions and recommendations, in the form of “words to the wise,” are included in the last slide of the presentation, e.g., an observation of p ~ 0.05 means nothing more than “worth another look.” d) Update on the GetProgram Klauenberg provided an update of the DoD/IEEE-SA C95 Get Program (Attachment 11). He reviewed the history of the agreement between DoD and IEEE SA noting that the contract runs out this April and so far there is no agreement that DoD will further support the program. He emphasized the fact that the IEEE C95 standards can be considered public health standards, not product standards, and should continue to be made freely available. He discussed the many benefits of the program its impact, e.g., in ratification of the NATO agreement to adopt IEEE Std C95.1-2345-2014 as the replacement for NATO STANAG 2345. It was pointed out that had the standards not been freely available it is unlikely that many of the NATO member countries would have been interested in the IEEE standards. He concluded his presentation by asking for ideas for finding support to continue the program. Several ideas were discussed, including the possibility of support from industry. Ideally, the goal is to find a benefactor willing to pay the entire cost to enable the program to move forward. Unapproved Minutes – 12 January 2016 TC95 Meeting 11. Subcommittee Reports a) SC1 (Measurements and computations) Colville discussed in detail prepared notes from the SC1 meeting. (See Attachment 12.) No action items. b) SC2 (Safety programs) Haes discussed prepared notes that described in detail highlights of the SC2. (See Attachment 13.) The following action items resulted from the SC2 meeting: • R. Tell to circulate RF Minimal Awareness Guide to ADHOC group. • R. Tell to circulate ideas or even the need for different low frequency signs to an ADHOC group • R. Tell to decide what to do about IEEE Std C95.2-1999. c) SC3 (Safety levels – 0 Hz to 3 kHz)/SC4 (Safety levels – 3 kHz to 300 GHz) SC3 and SC4 met together the previous day (11 January 2016)—Dovan and Ziskin presented the report. Most of the discussions during the SC3/SC4 meeting related to progress on the revision/merging of IEEE Stds C95.1-2005 and C95.6-2002. A number of issues were discussed at the meeting including the status of the literature evaluation process, the need to move the process forward effectively, and the increasing relevance of papers describing millimeter-wave and lowfrequency effects. The uncertainty in the SAR thresholds for animal data was discussed as was the need for human threshold SAR data. A number of presentations were given at the SC3/SC4 meeting on topics such as RF burns, ASC Z136 and TC95 issues at 300 GHz, and the possibility of effects of spark discharge on cardiac pacemakers and other wearable medical devices. Ziskin concluded by expressing appreciation to the members of ICES who were instrumental in the successful adoption of IEEE Std C95.1-2345-2014 by NATO on 26 November 2015 as the replacement of STANAG 2345 ed. 4—especially to B Jon Klauenberg who effectively drove the project forward. d) SC5 (Effects of EM fields on blasting operations) Harmon reported that SC5 met the previous afternoon (11 January 2016) and pointed out that this was the first face-to-face meeting in several years. (See Attachment 14.) The major issue discussed at the meeting was whether or not there is a need to update IEEE Std C95.4-2002 or expand the scope of the 2002 standard and that of the subcommittee. He noted that this issue was discussed during a teleconference in April 2015. The working group reviewed the 2002 standard and has considered it stable. One idea is to update the front matter and proceed to initiate sponsor ballot on the 2002 standard, which would be considered a revision. e) SC6 (EMF dosimetry modeling) Hirata reported that SC6 met earlier in the day. (See Attachment 15.) He noted that SC6 is now becoming more involved with modelling and dosimetry at RF frequencies. A proposed RF research agenda was discussed at the SC6 meeting and agreement was achieved to move forward with the agenda as proposed (slides 9 – 11). Hirata also noted that two new working groups were established—WG2: Quantification of effects of numerical artifacts in low frequency dosimetry; and WG3: Quantification of variability of induced current density and in-situ electric field strength. 12. ICES Website Update Chou provided an update on the ICES website (see Attachment 16). He pointed out that compared with 2014, the number of unique visitors in 2015 increased by 62% and the “period time” (not greater than 30 minutes) a user is actively engaged the website increased by 71%. He reminded everyone, especially new members, that they should post their bio-sketch on the website. 13. New Business No new business. Unapproved Minutes – 12 January 2016 TC95 Meeting 14. Future Meetings The next TC95 meeting series will be held in Ghent Belgium, in conjunction with and immediately before BioEM2016. A notice with preliminary details will be distributed mid-February. 15. Adjourn There being no further business, the meeting was adjourned at 1605 h. List of Attachments 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. Attendance List Approved Agenda SCC39 Chairman’s Report TC95 Chairman’s Report Secretary’s Report Treasurer’s Report Membership Chairman’s Report IEC TC106 and SCC39 TC34 Activity Update Transcranial Direct Current Stimulation (tDCS): Tasks for IEEE? Why are most positive experimental findings actually false? Update on C96 Get Program Highlights of SC1 Meeting (measurements and computation) Highlights of SC2 Meeting (safety programs) Highlights of SC5 Meeting (EM safety with respect to electric blasting caps) SC6 Activity Update ICES Website Statistics Action Items From January 2016 TC95 Meeting 1. Action Item Assigned to: Prepare a document for consideration by the ICES AdCom pointing out concerns associated with the use of transcranial direct current stimulation devices and what the specific role of ICES should be in addressing these concerns. Bikson (Lead) Chou, Kavet, Ziskin Status ATTACHMENT 1 Unapproved Minutes – 12 January 2016 TC95 Meeting Attendance List TC95 (Main Committee) Meeting – 12 January 2016 – 1230-1600 h 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. Last Name First Name Affiliation Country IEEE Member? Alon Leeor New York University US Y Bailey Bill Exponent US Y Balzano Q University of Maryland US Y Bikson Marom The City College of New York US Bodemann Ralf Siemens DE Y Butcher Matt SiteSafe US Y Chou C-K Independent Consultant US Y Cleveland Robert EMF Consulting US Colville Frank US Army PHC US Y Douglas Mark IT’IS Foundation CH Y Dovan Thanh Retired AU Faraone Antonio Motorola Solutions, Inc. US Futch James FL Dept. of Health US Gettman Graf Ken Kevin NEMA Exponent US Y US Y Haes Donald BAE Systems US Harmon Ray URS Corporation US Hatfield James H&D LLC US Hirata Akimasa Nagoya Inst of Technology JP Joyner Kavet Ken Robert Consultant EPRI AU US Y Keshvari Jafar Aalto University FI Y Kihlstrom Cory Verizon Wireless US Kim Soo (IEEE Staff Liaison) US Klauenberg B Jon USAF Human Effectiveness Dir. US Meltz Marty Retired US Petersen Ron R C Petersen Associates. LLC US Y Shelton Wesley AT&T US Y Sliney David Ind Consultant US Tell Ric Richard Tell Associates, Inc. US Visser Auke Royal Netherlands Navy NL Y Y Y Y Y Unapproved Minutes – 12 January 2016 TC95 Meeting Last Name 32. Wandel 33. Wessel 34. Ziskin ATTACHMENT 1 First Name Affiliation Country IEEE Member? Eric Wavepoint Research US Marvin Global RF Solutions US Y Marvin Temple University US Y Unapproved Minutes – 12 January 2016 TC95 Meeting ICES ATTACHMENT 2 International Committee on Electromagnetic Safety Approved Agenda TC95 Committee Safety Levels with Respect to Human Exposure to Electric, Magnetic and Electromagnetic Fields, 0 Hz to 300 GHz 1300 – 1700 Tuesday, 12 January 2016 Motorola Solutions, South Entrance (east entrance is closed) 8000 West Sunrise Blvd Plantation, FL 33322 1. Call to Order 2. Introduction of those Present 3. Approval of Agenda 4. Approval of June 13, 2015 TC95 minutes 5. ICES Chairman’s Report 6. TC95 Chairman’s Report 7. Executive Secretary’s Report 8. Treasurer’s Report 9. Membership Chairman’s Report 10. Topic presentations a) IEC TC106/IEEE TC 34 Update b) Transcranial Direct Current Stimulation ` 11. Subcommittee Reports a) SC1 (Measurements and computations) b) SC2 (Safety programs) c) SC3 (Safety levels – 0 Hz to 3 kHz) d) SC4 (Safety levels – 3 kHz to 300 GHz) e) SC5 (Effects of EM fields on blasting operations) f) SC6 (EMF dosimetry modeling) 12. ICES Website Update 13. New Business 14. Future Meetings 15. Adjourn Chou All Chou Chou Bodemann Chou Petersen Petersen Klauenberg Keshvari Bikson Colville/Douglas Tell Kavet/Dovan Ziskin/Thansandote Harmon/Hay Hirata Chou Chou Chou Unapproved Minutes – 12 January 2016 TC95 Meeting ATTACHMENT 3 ICES TC95 meeting, 10.01.2016, Dr. Ralf Bodemann Update EMF Regulations in Germany © Siemens AG 2016. Alle rights reserved. One world, one life – we care. Contents • Administrative Regulation to implement precautionary measures for low frequency facilities • Planning for national transposition of EU EMF Workers’ Directive 2013/35/EU © Siemens AG 2016. All rights reserved. Seite 2 Jan 10, 2016 Dr. Bodemann / HR EHS SF TR Need for Administrative Regulation on Precautionary Measures for ELF Facilites • German Ordinance for general public exposure revised end of 2014. • Mandates consideration of precautionary measures for newly installed ELF facilities or relevant changes • Scope: HV power lines and buried cables as well as transformer stations and HV switches for • DC Transmission Facilities (≥ 2000 V) • Railway Grid (16⅔ Hz) (≥ 1000 V) • General Electricity Transmission (50 Hz) (≥ 1000 V) • Goal: Implement a standardized assessment procedure for authorities in charge © Siemens AG 2016. All rights reserved. Seite 3 Jan 10, 2016 Dr. Bodemann / HR EHS SF TR Zones of Affected Burden and Assessment Distances for various ELF Facilites HV Power Lines (incl. Railway Power Lines) Max. Voltage Zone of Aff. Burden Assessment Distance ≥ 380 kV 400 m 20 m ≥ 220 kV bis < 380 kV 300 m 15 m ≥ 110 kV bis < 220 kV 200 m 10 m < 110 kV 100 m 5m Transformers and Switches Zone of Aff. Burden Assessment Distance Transformers and Switches ≥ 110 kV 100 m 5m Local Grid Station 20 m 1m © Siemens AG 2016. All rights reserved. Seite 4 Jan 10, 2016 Dr. Bodemann / HR EHS SF TR Zone of Affected Burden, Assessment Distances, Points of Reference (Power Lines and Buried Cables) Inside assessment distance: case-by-case assessment Outside assessment distance: Projection to point of reference © Siemens AG 2016. All rights reserved. Seite 5 Jan 10, 2016 Dr. Bodemann / HR EHS SF TR Zone of Affected Burden, Assessment Distances, Points of Reference (HV Switches and Transformer Stations) Inside assessment distance: case-by-case assessment Outside assessment distance: Projection to point of reference © Siemens AG 2016. All rights reserved. Seite 6 Jan 10, 2016 Dr. Bodemann / HR EHS SF TR Assessment Procedure at a Glance • For each type of ELF facility, the regulation provides a conclusive list of 2-5 technical precautionary measures which need to be considered • Implementation of precautionary measures must not lead to exposure increase at any building inside the ZoaB • Assessment has to consider econimical aspects. • Precautionary measures for 50 Hz HV power lines: optimization of distance, electric shielding, minimization of rope distances, optimization of mast geometry, optimization of configuratoin of conductors • Information on each combination of facility/measure, sometimes not very specific © Siemens AG 2016. All rights reserved. Seite 7 Jan 10, 2016 Dr. Bodemann / HR EHS SF TR Directive 2013/35/EU: Transposition into national law by July 2016 Directive 2013/35/EU • Contains minimum requirements for protection of safety and health of workers against EMF exposure • supersedes Directive 2004/40/EG • confirms safety philosophy for thermal effects of RF exposure (100 kHz – 300 GHz) • Revises limit values for ELF exposure (1 Hz – 10 MHz) for non-thermal effects (nerve stimulations) based on recent scientific reviews (ICNIRP 2010) • must be transposed into national legislation by July 1, 2016 © Siemens AG 2016. All rights reserved. Seite 8 Jan 10, 2016 Dr. Bodemann / HR EHS SF TR Limit values EU Directive vs. Basic Restrictions BGV B11 10000 in situ el. Feldstärke (peak) in V/m EU-Dir Health Effect ELV 1000 EU-Dir Sensory Effect ELV BMAS-Plan Health Effect 100 BMAS-Plan Sensory Effect 10 BGV B11 Basiswerte @ 0.2 S/m (peak) 1 0.1 0.01 0.01 0.1 1 10 100 1000 10000 100000 1000000 10000000 Frequenz in Hz © Siemens AG 2016. All rights reserved. Seite 9 Jan 10, 2016 Dr. Bodemann / HR EHS SF TR Magnetic Fields Action Values EU Directive – accepted values exposure area 2 BGV B11 EU-Dir low action level 1000000 EU-Dir high action level magn. Flußdichte in µT 100000 EU-Dir limb action value BMAS-Plan low AL 10000 BMAS-Plan high AL BGV B11 Expo 2 1000 100 10 1 0.1 0.01 0.1 1 10 100 1000 10000 100000 1000000 10000000 Frequenz in Hz © Siemens AG 2016. All rights reserved. Seite 10 Jan 10, 2016 Dr. Bodemann / HR EHS SF TR Electric Fields Action Values EU Directive – accepted values exposure area 2 BGV B11 100000 EU-Dir low action level EU-Dir high action level el. Feldstärke in V/m 10000 BGV B11 Expo 2 1000 100 1,617 MHz 1500 Hz 10 1 10 100 1000 10000 100000 1000000 10000000 Frequenz in Hz © Siemens AG 2016. All rights reserved. Seite 11 Jan 10, 2016 Dr. Bodemann / HR EHS SF TR Medical Implants – just an Action Values for static magnetic fields Problem: In DC drivens trains and trams, this value can be exceeded. According to European standards, implants are immune up to 1,0 mT © Siemens AG 2016. All rights reserved. Seite 12 Jan 10, 2016 Dr. Bodemann / HR EHS SF TR Kontakt Dr. Ralf Bodemann Corporate EHS Manager CHR EHS SF RD Otto-Hahn-Ring 6 81739 München Mobil: +49 (173) 856 11 84 E-Mail: ralf.bodemann@siemens.com Intranet: https://intranet.siemens.com/ehs © Siemens AG 2016. All rights reserved. Seite 13 Jan 10, 2016 Dr. Bodemann / HR EHS SF TR Unapproved Minutes – 12 January 2016 TC95 Meeting ATTACHMENT 4 TC95 Chairman’s report, January 12, 2016 ICES Mission: “Promoting safe use of electromagnetic energy” 1. On November 26, 2015, NATO adopted C95.1-2345-2014 as STANG Ed. 4. Thanks to B Jon Klauenberg for this tireless efforts. 2. Colombi et al. (2015) published a paper pointed out big discrepancy of exposure limits for power density above 6 GHz for future 5 G Communication products. C95.1-2005 has the most consistent limits than that of ICNIRP and FCC. D. Colombi, B. Thors, and C. Tornevik, “Implications of EMF Exposure Limits on Output Power Levels for 5G Devices above 6 GHz,” IEEE Antennas and Wireless Propagation Letters, vol. PP, no. 99, pp.1, Feb. 2015 3. Three presentations: a. Safety Issues of Radiofrequency Exposure. International Broadcasting Convention, Amsterdam, the Netherlands, September 11, 2015. b. Radio Frequency Exposure Safety Concerns: Research, Standards, Regulatory Status and Risk Communication. EMF Risk Assessment and Risk Communication. National Communications Commission. Taipei, Taiwan. October 17, 2015. c. RF exposure standards and regulations. International symposium on RF fields and human health. National Broadcast and Telecommunication Commission. N Bangkok, Thailand, December 18, 2015. 4. Two publications: Presented at 8th International Workshop on Biological effects of Electromagnetic Fields, Varna, Bulgaria, September 23, 2014. a. IEEE EMF exposure and assessment standards activities. Bulgarian Journal of Public Health, ISSN 1313-860X, Supplement Vol. VII, No. 2(1): 115-120, 2015. http://ncphp.government.bg/files/spisanie/BG_JURNAL_2015_2_1.pdf Unapproved Minutes – 12 January 2016 TC95 Meeting ATTACHMENT 4 b. A need to provide explanations for observed biological effects of radiofrequency exposure. Electromagnetic Biology and Medicine, 34(3):175-179, 2015. “Researchers should look for explanations for their own findings, and not expect others to figure out what was the reason for their observed effects.” 5. Meeting reports: a. IBC in Amsterdam: about 40 attended the session. Unapproved Minutes – 12 January 2016 TC95 Meeting ATTACHMENT 4 b. NCC in Taiwan: about 150 attended the one day session. c. NBTC in Bangkok: about 120 attendants with activists demanding to lower exposure limits to 0.6 V/m as proposed in 2007 BioInitiative Report. Program, see attached. Unapproved Minutes – 12 January 2016 TC95 Meeting ATTACHMENT 4 Interaction with WHO, Emile agreed to promote collaboration with ICNIRP to work out a science based, with new Chairman Eric van Rogen (a member of ICES). Congratulations to Aki Hirata, a newly elected member. ICES and ICNIRP should be collaborative partners and not competitive, to work out a world harmonized standard. 6. Thursday afternoon, I will give a presentation on “IEEE ICES TC95 Exposure Standard Activities” in ICES TC34/IEC TC106 meeting to give measurement colleagues a perspective on the development of ICES exposure standards. 7. Encourage members to attend the Ghent, Belgium meeting in June. Attract new and young members to join ICES. 8. Invited by BioEM2016 technical program committee to give a tutorial presentation on ICES standards activities. Unapproved Minutes – 12 January 2016 TC95 Meeting ICES ATTACHMENT 5 International Committee on Electromagnetic Safety Secretary’s Report TC95 Meeting 12 January 2016 Motorola Solutions, Inc. Plantation, FL R Petersen TC95 12 January 2016 Plantation, FL IEEE ICES ICES –Administrative Policies and Procedures (P&P): Defines organizational structure (SCC-39) Based on “SA Baseline P&Ps for Type 2 SCCs” (with deviations) Revision of 2007 P&Ps accepted by SASB, December 2012 Working Group (SC) P&Ps are now Required WG P&Ps deemed “without issue” by AudCom, June 2013 Annual Report (2014-2015): Accepted by SASB, December 2015 Annual reports going back to 2000 are available at http://www.ices-emfsafety.org/publications/reports/ TC95 12 January 2016 Plantation, FL IEEE ICES ICES TC95 Standards: Status C95.1-2005: (Safety levels, 3 kHz – 300 GHz) Approved 2005; published 2006 PAR for revision – approved June 2010, PAR extension request approved December 2014—expires 31 December 2016 Revision will incorporate C95.6 (Safety levels, 0 Hz to 3 kHz) PC95.1a: (Safety levels, 3 kHz – 300 GHz) Published May 2010 Amendment 1 (sets ceiling values for induced and contact current) C95.1-2345-2014: (Safety levels, 0 Hz – 300 GHz) Approved 16 May 2014; published 30 May 2014 Replaces NATO STANAG 2345 TC95 12 January 2016 Plantation, FL IEEE ICES ICES TC95 Standards: Status C95.2-1999: (RF energy and current flow symbols) Reaffirmed 2005 PAR for Revision – approved November 2010; expired 31 December 2014 C95.3-2002: (RF measurements and computation: 100 kHz to 300 GHz) Reaffirmed 2008 PAR for Revision – approved 6 February 2012; expires 31 December 2016 Revision will incorporate C95.3.1 PC95.3.1: (Measurements and computation: 0 Hz to 100 kHz) Incorporates IEEE Std 1460 Published May 2010 TC95 12 January 2016 Plantation, FL IEEE ICES ICES TC95 Standards: Status C95.4-2002: (Safe distances from antennas during blasting operations) Reaffirmed 2008 C95.6-2002: (Safety levels – 0 to 3 kHz) Reaffirmed 2007 Will be incorporated into C95.1 (Safety levels, 3 kHz to 300 GHz) C95.7-2014: (RF safety programs) Revision of C95.7-2005 Approved 12 June 2014; published 8 August 2014 TC95 12 January 2016 Plantation, FL IEEE ICES ICES TC95 Standards: Status 1460-1996: (Measurement of quasi-static electric and magnetic fields) Reaffirmed 2008 Incorporated into C95.3.1 Action – Withdraw? Archive? TC95 12 January 2016 Plantation, FL IEEE ICES SCC39 Standards: Expiration Dates Number Year Approval Date Expiration Date 1460 1528 C95.1 C95.1a C95.1-2345 C95.2 C95.3 C95.3.1 C95.4 C95.6 C95.7 1996 2013 2005 2010 2014 1999 2002 2010 2002 2002 2014 12/10/1996 06/12/2013 10/03/2005 02/02/2010 05/16/2014 09/16/1999 12/11/2002 03/25/2010 11/11/2002 09/12/2002 06/12/2014 12/31/2018 12/31/2023 12/31/2018 02/02/2020 12/31/2024 12/31/2018 12/31/2018 03/25/2020 12/31/2018 12/31/2018 12/31/2024 TC95 12 January 2016 Plantation, FL IEEE ICES Get C95™ Standards Access to the following standards at no cost has been sponsored by the US Navy, US Air Force, and US Army:* • • • • • • • • IEEE IEEE IEEE IEEE IEEE IEEE IEEE IEEE Std Std Std Std Std Std Std Std C95.1TM-2005 C95.1aTM-2010 C95.1-2345TM-2014 C95.3TM-2002 C95.3.1TM-2010 C95.6TM-2002 C95.7TM-2005 C95.7TM-2014 http://standards.ieee.org/about/get/ *Sponsorship of the Get IEEE C95 no-cost-to-public web access of the IEEE C95 standards does not imply that the Department of Defense nor its Component Services endorse or are obligated in any manner to adopt the covered standards current or future versions. TC95 12 January 2016 Plantation, FL IEEE ICES IEEE GetProgram: C95 Standards Download Statistics Standard C95.1-2005 C95.1a-2010 C95.1-23452014 C95.3-2002 C95.3.1-2010 C95.6-2002 C95.7-2005 C95.7-2014 Total TC95 12 January 2016 Plantation, FL Total Downloads 2012 2013 2014 2015 Total 1493 0 1359 0 1029 0 902 309 4783 309 164 344 508 389 284 344 294 238 2742 329 264 322 199 494 3163 571 472 620 515 345 532 485 422 3671 3143 1634 1552 1771 1430 732 12,719 IEEE ICES IEEE GetProgram: C95 Standards Download Statistics Interest Category Military User Safety/Risk Manager Other Commercial User Research Scientist Government user (non Military) Academic/Student Standards Developer Unknown Total TC95 12 January 2016 Plantation, FL Total 2012 2013 2014 2015 Total 219 367 588 662 603 216 462 506 615 339 184 418 366 494 363 264 471 423 512 386 883 1718 1883 2283 1691 407 307 332 433 1479 660 163 2 3671 582 109 483 102 581 93 3111 2742 3163 2306 467 2 12,687 IEEE ICES IEEE GetProgram: C95 Standards Download Statistics (2015) User C95.1 C95.1a C95.12345 C95.3 C95.3.1 C95.6 C95.7 (2005) C95.7 (2014) Total . academic/student 175 48 53 65 69 54 35 82 581 commercial 161 55 30 59 30 59 32 86 512 gov't (nonmilitary) 125 59 53 40 28 41 26 61 433 military 57 21 92 23 9 12 13 37 264 other 112 36 39 46 42 49 28 71 423 research scientist 119 30 41 39 30 44 26 57 386 safety/risk manager 116 43 31 51 50 58 36 86 471 standards developer 37 17 5 6 6 5 3 14 93 902 309 344 329 264 322 199 494 3163 Total TC95 12 January 2016 Plantation, FL IEEE ICES Active TC95 Project Authorization Requests (PARs) Project Approval Date Expiration Date PC95.1 17 June 2010 31 December 2016 PC95.2 8 November 2010 Expired PC95.3 6 February 2010 31 December 2016 . TC95 12 January 2016 Plantation, FL IEEE ICES Changes: Interpretations Elimination of Interpretations: In June 2011 the IEEE- SA Standards Board approved a proposal to eliminate issuing interpretations Rationale: Inefficient and a risk TC95 12 January 2016 Plantation, FL Interpretation responses made in an attempt to clarify ambiguous text to be derived from a process that does not inform all materially interested parties of the activity Does not require consensus to be achieved through the Sponsor balloting process IEEE ICES Changes: Interpretations Solution: More sensible to simply funnel comments on standards to Sponsors for handling Any document changes would appear in a revision amendment/corrigendum All require PARs – an open process & consensus through balloting Therefore interpretations as discrete documents are discontinued TC95 12 January 2016 Plantation, FL IEEE ICES Changes: Individual Experts Individual Expert: Members of the working groups who are not SA members but contributed significantly to the development of standard could participate in sponsor ballots if approved by the SASB as “individual experts” Individual Expert category has been eliminated Now, only IEEE-SA Members or individuals who pay a fee are permitted to vote on IEEE sponsor ballots TC95 SC/WGs follow IEEE sponsor balloting procedures at the committee level before going to sponsor ballot TC95 members and members of the TC95 SCs and WGs who are not IEEE-SA members and desire to vote on a standard should join the SC/WG ballot groups TC95 12 January 2016 IEEE ICES Plantation, FL Secretary’s Report Questions? TC95 12 January 2016 Plantation, FL IEEE ICES Unapproved Minutes – 12 January 2016 TC95 Meeting ICES ATTACHMENT 6 International Committee on Electromagnetic Safety Treasurer’s Report TC95 Meeting 12 January 2016 Motorola Solutions, Inc. Plantation, FL R Petersen TC95-12 January 2016 Plantation, FL IEEE ICES Financial Statement: 1/1/15—12/31/15 Balance (1/1/2015) $ 13,313.22 Income $ $ $ 7125.67 40.53 7166.21 $ $ $ $ 1491.80 939.40 400.00 150.60 Total Expenses Total Balance (12/31/15) TC95-12 January 2016 Plantation, FL June 2015 Meeting Interest June 2015 Meeting Database Maintenance Web Hosting and Update Credit Card Processing $2981.80 $ 17,497.62 IEEE ICES ATTACHMENT 7 Unapproved Minutes – 12 January 2016 TC95 Meeting ICES TC95 Membership Report 12 January, 2016 Plantation, FLA Dr. B Jon Klauenberg USAF Research Laboratory 711th Human Performance Wing Human Effectiveness Directorate Bioeffects Division Radio-Frequency Bioeffects Branch DRAFT not for circulation release ICES TC95 Membership Report Outline • • • • Recent New Members Current Membership Maintaining Official Membership in ICES TC95 Becoming a Member of ICES DRAFT Distribution A: Approved for public release; PA # TSRL 15- 2 Welcome Our New Members to ICES TC95 William Mueller, St. Louis MO, accepted 30 November, 2015 Kevin Graf, Menol Park, CA, accepted 30 November, 2015 Alexandre Legros, London, Ontario, accepted 30 November, 2015 Ayman Ekram Fahim, Ismailia, Egypt, accepted 30 November, 2015 Michal Cifra, Prague, Czech Republic, accepted 30 November, 2015 Cory Kihlstrom, Avon Indiana, accepted 28 December, 2015 DRAFT not for circulation or release 3 Members in ICES TC95 (2009-2010) Rajat Mathur, Calafornia – accepted 15 January 2009 Amnon Duvdevany, Israel - accepted 15 January 2009 Donald Farrer, San Antonio - accepted John Brewer, USAF, Singapore- accepted Rodney Croft, Australia - accepted 8 April 2009 Dave Cotton, Colorado – accepted 8 April 2009 Rene De Seze, France - accepted 22 April Hiroaki Miyagi, Japan – accepted 15 July 2009 Akinasa Hirata, Japan – accepted 12 Dec 2009 Niels Smit, Netherlands – accepted 10 Feb 2010 Jin Hongbin, China – accepted 17 Feb 2010 Tamera Hay. USA – accepted 14 April 2010 Ae-Kyoung Lee, Korea – accepted 14 April 2010 Shrivastava, Devashish, USA – accepted 16 July 2010 Chungsang Ryu, Korea – accepted 16 July 2010 Kenichi Yamazaki, Japan – accepted 16 July 2010 DRAFT Distribution A: Approved for public release; PA # TSRL 15- 4 Members in ICES TC95 (2010-2013) Daoud Attayi, Canada – accepted 5 October 2010 Martin R. Doczkat, USA – accepted 5 October 2010 Mark Douglas, Switzerland – accepted 13 January 2011 Byung, Chan Kim, Korea – accepted 8 July 2011 Shkolnikov, Yakov, USA – accepted 8 July 2011 Zhadobov, Maxim, France – accepted 8 July 2011 Christine M. Jones, USA – accepted 12 October 2011 Frank Colville – USA – accepted 17 November 2011 Sam Adhikari, USA – accepted 05 December 2011 Martin Gledhill, NZ – accepted 05 May 2012 Wes Mundy, CA – accepted 18 July 2012 Dave Dini, USA – accepted 31 August 2012 Hai Jiang, USA – accepted 31 August 2012 Ray Harmond, USA – accepted 23 Jan 2013 Bob Johnson, USA – accepted 23 Jan 2013 DRAFT Distribution A: Approved for public release; PA # TSRL 15- 5 Members in ICES TC95 (2013-2014) Gabor Mezei, USA- accepted 29 April 2015 Valerio De Santis, ITA-accepted 5 May 2015 Suraj Sinda, USA-accepted 7 May 2015 DRAFT Distribution A: Approved for public release; PA # TSRL 15- 6 Members in ICES TC95 (2015- ) Marv Wessel Jr., USA – accepted 23 Jan 2013 Leeor Alcon, USA – accepted Feb 2013 Vijayalaxmi, USA – accepted March 2013 TV Ramachandran, India – accepted March 2013 Matt Butcher, USA – accepted November 2013 Wes Shelton, USA – accepted December 2013 Ilkka Laakso, IT-accepted 25 September 2014 Joe Bowman, US-accepted 18 Nov 2014 Auke Viser, NE-accepted 6 June 2014 Peter Valberg US-accepted 9 May 2014 Christopher Sheppard US-accepted 22 April 2014 Michael Delgato US-accepted 11 April 2014 Antonio Faraone US-accepted 6 February 2014 James Futch US-accepted 15 January 2014 Benjamin Cotts US-accepted 15 January 2014 DRAFT Distribution A: Approved for public release; PA # TSRL 15- 7 TC95 membership, January 2016 - 130 Members 27 countries AUS - 4 BGR - 1 CAN - 7 CHE - 3 CZE -1 CHN - 2 DEU - 1 FIN - 1 FRA - 2 GRC - 4 HUN - 1 IND - 1 IRL - 4 ISR – 2 ITA – 4 JPN - 5 KOR - 4 MYS - 3 NLD - 2 NZL - 1 POL - 1 SWE - 1 SVN - 1 THA - 1 TUR - 1 GBR - 2 USA - 70 DRAFT for public release; PA # TSRL 15- 8 Maintaining Official Membership in ICES TC95 • Following the ICES Winter meeting each year, the membership roles will be reviewed. Members who joined ICES before that year, who have not attended meetings or otherwise participated in the business of ICES that year, will be contacted to determine if they are still interested in maintaining official membership in the Committee. Those failing to respond will be dropped from the membership roles. The membership of individuals who joined ICES within that year will be reviewed at the end of the next calendar year. DRAFT Distribution A: Approved for public release; PA # TSRL 15- 9 Privileges of Official Membership on IEEE ICES TC95 • Access to protected part of ICES Website • E-mail notification of meetings and other events • Permission to publically cite self as “Member of ICES TC95” • Listing in the preface of IEEE C95 standards, if you contribute • Inclusion in membership statistics • Voting on committee issues at meetings and by letter (e-mail) ballot • Participating in ballots on ICES standards, subject to IEEE rules To apply for membership, e-mail Membership Chair bertram.klauenberg@us.af.mil 10 Unapproved Minutes – 12 January 2016 TC95 Meeting ATTACHMENT 8 TC106 & TC34 Activity & Progress Update to ICES IEEE/ICES AdCom meeting, Jafar Keshvari IEC TC106 • New Chairman since May 2015, Mike Wood • New Secretary since 2015, Matthias Meier • The 5 year Strategic Business Plan will see the internet of things, 5G and a truly connected world. There will be a significant growth in wireless power transfer technology towards a world where ‘everything is connected and charges wirelessly. • IEC TC106-D15/03 TC106 set up a working group to address wireless power transfer systems and approved the terms of reference. Mr. Teruo Onishi was nominated Convenor. TC106 noted Mr. Kenichi Yamazaki’s presentation on a proposal to address contact currents (docs Stresa2015-09, Stresa-2015-10). IEC • TC106-D15/04 TC106 set up a working group on contact currents and approved the terms of reference. Mr. Kenichi Yamazaki was nominated Convenor. Tc 106 amended the strategic objectives and actions. • IEC TC106-D15/05 TC106 approved the draft Strategic Business Plan and task the secretariat to edit the draft before submitting it to the SMB. IEC MT1 activity update Pic from Oct 2015 meeting, Venice-Italy IEC MT1 activity update, General • IEC 62209-1 CDV2 (head SAR assessment std) voting ended on 23 Jan 2015. • CDV2 approved by 87.5%. • ~1000 comments were received!! • All commnets are discussed and addressed by MT1 • Technical comments which may had caused problems during FDIS voting are avoided. • FDIS was sent to for voting. Date of circulation 2014-1017. Closing date for voting (Voting mandatory for Pmembers) 2015-01-23. IEC MT1 activity update… • In IEC MT1 a new ad-hoc team is stablished to address the compliance assessment of wearable devices such as head monuted displays or writ watch type devices. • Focus of the activities in IEC MT1 is on unification of part 1 and part 2 stadards. IEC 62209-2 Activity update • There are no major technical questions left with IEC 62209-2 • Main focuses have been: • Tissue dielectric parameters rationale. • Addressing comments from national committee’s. • Harmonization with part I. • Challenges with unification IEC 62209 standards Timeline IEC 62209-1 FDIS submitted on Sep 2015 Unification of parts -1 & -2 completed by Oct 2016 FDIS of unified std finalized by the end of 2016 or early 2017 Progress update on IEC PT 62209-3 activities Human exposure to radio frequency fields from hand-held and body-mounted wireless communication devices - Human models, instrumentation, and procedures – Part 3: Vector probe systems (Frequency range of 100 MHz to 6 GHz) IEC PT 62209-3, General • A lot of intrest from SAR instrumentation manufacturers towards this activity. • Intensive discussions on the definition of the vector probe and scope of the std. • Publishing an intrim document such as TR, TS is proposed. • Dual logo for IEC PT 62209-3 standard. IEC 62209-3, main items under development • One of the focuses is to make the std as generic as possible to allow emerging new technologies • System validation: The goal of the validation is to ensure uniform results within reasonable measurement uncertainties. Different labs will be working separately and providing input to the relevant clause • SAR verification: Array systems are generally closed systems for which the different parts of the system are not independently accessible. Therefore, the verification of such a system must be based on a comprehensive set of calibrated sources with respect to fields that may be induced in the phantoms. • Verification source: It is agreed that the standard must include requirements for the verification source, for the procedure and for the system set up. • Uncertainty clause, one of the most demanding part of the std. IEC 62209-3 Timeline IEC 62209-3 CD or TR/TS by Feb 2016 IEC 62209-3 CDV by the end of 2016 FDIS in 2017 IEEE/IEC stds update • • • • Activity update on IEEE/IEC 62704-1 standard Activity update on IEEE/IEC 62704-2 standard Activity update on IEEE/IEC 62704-3 standard Activity update on IEEE/IEC 62704-4 standard Activity update on IEEE/IEC 62704-1 standard (General FDTD Methods) • IEC/IEEE 62704-1 • WG Chair: A. Christ (Brazil) • Start date: 10/2010 • Status: • Comments recived on CD from NC’s and IEEE/ICES TC34 committee are addressed • The CDV is ready to be sent for voting • IEEE-SA Standards Board approved the extension request, 31 Dec 2016. Activity update on IEEE/IEC 62704-2 standard (Vehicle Mounted Antennas) • IEC/IEEE 62704-2 • WG Chair: Goga Bit-Babik (US) • Start date: 10/2010 • Comments recived on CD from NC’s and IEEE/ICES TC34 committee are addressed • The CDV is sent to IEC TC106 secretary and IEC office in Sep 2015 and for balloting in IEEE in Dec 2015. • IEEE-SA Standards Board approved the extension request, 31 Dec 2016. Activity update on IEEE/IEC 62704-3 standard (modeling of mobile phones) • IEC 62704-3 • WG Chair: Vikass Monebhurrun (France) • Start date: 10/2010 • Status: • Comments recived on CD from NC’s and IEEE/ICES TC34 committee are addressed • Major challenge is benchmarking and how to get CAD files from manufacturers which is under discussion • IEEE-SA Standards Board approved the extension request. 31-Dec2017. Activity update on IEEE/IEC 62704-4 standard (Finite Element Method) • IEC 62704-4 • WG Chair: Martin Vogel • Start date: 10/2011 • Description of FEM • SAR calculation and averaging • Tissue modeling and anatomical models • Uncertainty and code validation • Status: • Andreas Christ, the new chairman has been sucessfull in intiating the activity. There are intrests from industry towards this project. • Planed CD for 2016. • IEEE-SA Standards Board approved the extension request. 31-Dec2017 ITU SG5 update • No significant EMF activity since last update IEC base station std activity report Thank you, ?... Unapproved Minutes – 12 January 2016 TC95 Meeting ATTACHMENT 9 Transcranial Direct Current Stimulation (tDCS): Tasks for IEEE? Marom Bikson, PhD Professor of Biomedical Engineering, The City College of New York of CUNY Director Neural Engineering Group of the New York Center for Biomedical Engineering Technology Editor, Brain Stimulation Journal Transcranial Direct Current Stimulation (tDCS) • A non-invasive electrical stimulation device used for medical and neuroenhancement purposes • Electrodes on the head apply ~2 mA for ~20 minutes (~20 V) • Electrode position determines which brain regions are targeted. Peak brain electric fields: ~ 1 V/m (compare implants: 100 V/m) • In the US, while medical applications are regulated, regulation on neuro-enactment is unclear Transcranial Direct Current Stimulation (tDCS) • Consumer tDCS and other variants using electrical stimulation broadly available and used • Some devices meet no industry / regulatory standards Transcranial Direct Current Stimulation (tDCS) • ~100,000 users of “consumer” and off-label medical tDCS in 2015 • Interest fueled by media and human trials Transcranial Direct Current Stimulation (tDCS) • ~100,000 users of “consumer” and off-label medical tDCS in 2015 • Interest fueled by media and human trials Human trials on: Depression Pain, Migraine Epilepsy, Stroke Rehab PTSD, TBI, ADHD Accelerated Learning (DoD) • Creativity, Vigiliance • “Math” / “Reading” Skills • • • • • Transcranial Direct Current Stimulation (tDCS) • ~100,000 users of “consumer” and off-label medical tDCS in 2015 • Interest fueled by media and human trials Media coverage in: • New York Times • BBC • ABC • New Yorker • Wired • Guardian • Nature / Science • Economist… Transcranial Direct Current Stimulation (tDCS) • ~100,000 users of “consumer” and off-label medical tDCS in 2015 • Interest fueled by media and human trials Transcranial Direct Current Stimulation (tDCS) • Inaction: The central challenge of physicians, scientists, regulator agencies (FDA, CE), companies in developing regulation and use controls is lack of engineering standards. • Safety: Exceptional safety record in control human trials using devices made to medical standards confuses brooder discussion of safety. • Such engineering standards should define the terminology, reference standards (IEC), and terms of use necessary for regulation and control. • The central issue is no restricting access or safety standards but Quality Control. IEEE (IEC) has established standards for Quality Control. Unapproved Minutes – 12 January 2016 TC95 Meeting ATTACHMENT 10 Why are most positive experimental findings actually false? John P. A. Ioannidis: Why Most Published Research Findings Are False. PLoS Med. 2,e124 (2005). David Colquhoun: An investigation of the false discovery rate and the misinterpretation of p-values. R. Soc.open sci. 1:140216. http://dx.doi.org/10.1098/rsos.140216. (2014). Opening lines of Colquhoun Paper: If you use p = 0.05 to suggest that you have made a discovery, you will be wrong at least 30% of the time. If, as is often the case, experiments are underpowered, you will be wrong most of the time. A typical experiment examines the difference between a control group and an exposed group of animals. If the statistical analysis of the difference shows that p < .05, the investigator concludes that the exposure caused a bioeffect. However, under many, if not most, experimental conditions this will be a false conclusion. That is, there really is no bioeffect. The reason for this false conclusion stems from the frequent misinterpretation of what p < 0.05 means. p < 0.05 is frequently mis-interpreted as: p < 0.05 means: probability(effect) = 95%. FALSE P < 0.05 really means that if there is no effect, the probability of getting as large a difference as found, would be less than 5%. The key thing is that the statement p < 0.05 is a compound probability statement, that is: p < 0.05 means P(sig | no effect) < 0.05 TRUE Power is the probability of obtaining a significant result if there is an effect. That is, 𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝 = 𝑃𝑃 𝑠𝑠𝑠𝑠𝑠𝑠 𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒) POWER AND SAMPLE SIZE Sample Size (N): Where 𝑁𝑁 = σ 𝛿𝛿 Zα Zβ = = = = = 2 𝜎𝜎 2 (𝑍𝑍𝛼𝛼 − 𝑍𝑍𝛽𝛽 )2 𝛿𝛿 2 standard deviation minimum difference to be detected 1.645 for p = 0.05 (1 way) - 0.842 for power = 0.80 -1.282 for power = 0.90 RULES OF CONDITIONAL PROBABILITY P(A | B) is the Probability of A, given that B has occurred P(A & B) is the Probability that both A and B have occurred 𝑃𝑃 𝐴𝐴 & 𝐵𝐵 P 𝐴𝐴 𝐵𝐵) = = 𝑃𝑃 𝐴𝐴 𝐵𝐵) · 𝑃𝑃 𝐵𝐵 𝑃𝑃(𝐴𝐴 & 𝐵𝐵) 𝑃𝑃(𝐵𝐵) 𝑃𝑃 𝐴𝐴 = = and 𝑃𝑃 𝐴𝐴 & 𝐵𝐵 + 𝑃𝑃 𝐵𝐵 𝐴𝐴) · 𝑃𝑃(𝐴𝐴) 𝑃𝑃 𝐵𝐵 𝐴𝐴) = 𝑃𝑃(𝐴𝐴 & 𝑛𝑛𝑛𝑛𝑛𝑛 𝐵𝐵) 𝑃𝑃(𝐴𝐴 & 𝐵𝐵) 𝑃𝑃 𝐴𝐴 𝑃𝑃 𝑠𝑠𝑠𝑠𝑠𝑠 𝑃𝑃 𝑠𝑠𝑠𝑠𝑠𝑠 = = 𝑃𝑃 𝑠𝑠𝑠𝑠𝑠𝑠 𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒) · 𝑃𝑃 𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒 𝑃𝑃 𝑠𝑠𝑠𝑠𝑠𝑠 1 = 1 𝑃𝑃 𝑠𝑠𝑠𝑠𝑠𝑠 & 𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒 = = + 𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝 · 𝑃𝑃 𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒 𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝 · 𝑃𝑃(𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒) + 𝑃𝑃 𝑠𝑠𝑠𝑠𝑠𝑠 𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇 𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃 𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅 + 𝑃𝑃 𝑠𝑠𝑠𝑠𝑠𝑠 & 𝑛𝑛𝑛𝑛 𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒 + 𝑃𝑃(𝑠𝑠𝑠𝑠𝑠𝑠 𝑛𝑛𝑛𝑛 𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒 · 𝑃𝑃 𝑛𝑛𝑛𝑛 𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒 + 0.05 · 𝑃𝑃 𝑛𝑛𝑛𝑛 𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒 0.05 · 𝑃𝑃(𝑛𝑛𝑛𝑛 𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒) 𝑃𝑃(𝑠𝑠𝑠𝑠𝑠𝑠) 𝐹𝐹𝐹𝐹𝐹𝐹𝐹𝐹𝐹𝐹 𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃 𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅 EXAMPLE Power = 80% P(effect) = 10%, P(no effect) = 90% Then P(sig) = power · P(effect) + 0.05 · P(no effect) = 0.80 · 0.10 = 0.08 = 0.125 + 0.05 · 0.90 + 𝐹𝐹𝐹𝐹𝐹𝐹𝐹𝐹𝐹𝐹 𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃 𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅 = = = 0.045 0.05 · 𝑃𝑃(𝑛𝑛𝑛𝑛 𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒) 𝑃𝑃(𝑠𝑠𝑠𝑠𝑠𝑠) 0.05 · 0.90 0.125 0.36 Experiments in which P(effect) = 10% False Positive Rates Power Prob. False Pos. (%) Effect (%) Rate (%) 90 10 33 80 10 36 70 10 39 60 10 43 50 10 47 40 10 53 30 10 60 20 10 69 10 10 82 Experiments in which P(effect) = 50% Power Prob. False Pos. (%) Effect (%) Rate (%) 90 50 5 80 50 6 70 50 7 60 50 8 50 50 9 40 50 11 30 50 14 20 50 27 10 50 33 Experiments in which P(effect) = 1% Power (%) Prob. Effect (%) False Pos. Rate (%) 90 1 85 80 1 86 70 1 88 60 1 89 50 1 91 40 1 93 30 1 94 20 1 96 10 1 98 Recommendations Avoid doing underpowered experiments Burton, et al (2013): We optimistically estimate that the median statistical power of studies in the neurosciences to be between 8% and 31%. Never, ever, use the word “significant” in a paper. If you use a significance test, just state the p-value, and give the difference and confidence interval. Unless p < 0.001 don’t claim that you have made a discovery. Alternatively, use a three-sigma rule. An observation of p ~ 0.05 means nothing more than “worth another look”. All negative studies should be reported. Unapproved Minutes – 12 January 2016 TC95 Meeting ATTACHMENT 11 “GET” benefits to IEEE 1. Increased awareness of IEEE-SA and International Committee on Electromagnetic Safety (ICES) expert standardization capabilities and products globally 2. International recognition of IEEE has expanded as a result of GET a. Scientists, standards setters, compliance technicians and others have praised the free simple access b. Can improve international harmonization with other EMF health and safety guidelines, Directives and standards 3. Enhances IEEE public face with regard to public health and safety and charitable portfolio Impacts to IEEE if free access is withdrawn 1. Significant loss of users a. International standards implementers have demanded free access, especially for ratification of NATO Standardization Agreement (STANAG) 2345, which was promulgated 26 Nov 2015 covering IEEE C95.1-2345. b. Several NATO nations have stated that they will use other standards that are no-cost such as those offered by the International Committee on Non-Ionizing Radiation Protection (ICNIRP). 2. Loss of good will and prestige garnered through “GET” no-cost access, especially international and at NATO 3. NATO Standardization Office (previously NATO Standardization Agency) concern/desire to place C95.1-2345TM-2014 standard in data-base. Is this a possible impact to IEEE-NATO TCA? 4. Possible loss of IEEE/ICES participants. Impacts to public if free access is withdrawn 1. Compliance assessors will increasingly use outdated materials or chose to use other guidelines and public health and safety will not be managed through updated IEEE/ICES standards 2. Confidence in IEEE standards will be diminished when the public can no longer access the standard at no-cost “GET” benefits to sponsor 1. 2. 3. 4. Sponsorship highlighted at “GET” program web link Expands international and recognition Opportunity to get name recognized and “draw” new customers Increases awareness of sponsor products Unapproved Minutes – 12 January 2016 TC95 Meeting ATTACHMENT 12 IEEE TC95 SC-1 General Committee Update: 1. The meeting of SC-1 was convened at the Sawgrass Room of the Holiday Inn, on June 10, 2016 at 0815AM. 22 members attended the SC-1 meeting. 2. Update on C95.3 Standard Review: Mr. Frank Colville/C0-Chairman of SC-1 is currently consolidating the C95.3 standard by combining the document sections based on the topics/paragraphs being addressed. The original concept was to draft the standard based on the operating frequency, however, this would result in a large amount of duplicated information. Therefore, it appears the most practical procedure would be to combine the topics/methods/paragraphs and address the frequency differences in sub-paragraphs. Further, the editorial review process will be amended to review the standard. 3. Update on Industry Canada: Mr. Antonio Faraone reported that he received information regarding Industry Canada's intent to lower of the MPE limits across a broad frequency range. This decision appears to be prompted by Industry Canada's concern pertaining to whole body resonance of newborn-sized babies. Also, some IEEE members have stated that they have been contacted subsequent to Antonio’s update. 4. Presentation and update on Spatial Averaging Working Group: Mr. Bob Cleveland presented an update on the lack of information pertaining to spatial averaging. Mr. Cleveland has volunteered to chair the spatial averaging working group. The spatial averaging working group was just formed in September 2015. The first task will be to define the primary objectives pertaining to spatial averaging. The current plan is to develop suggested recommendations for SC-1 to consider with respect to amending the C95.3 standard to provide specific guidelines on spatial averaging. 5. Presentation entitled, "Random Thoughts about Measurement for Compliance for Consideration by IEEE SC-1". Mr. Ric Tell gave a short presentation on "Random Thoughts About Measurement for Compliance for Consideration by IEEE SC-1". Mr. Tell stated that of primary importance was the reliability of RF evaluations. Many RF evaluations currently being conducted contain a "lot of slop". In order to improve the RF reliability, we need to calculate/measure the magnitude of this "slop". For example, in many cases calculations apply a ground reflection factor that is inappropriate. Mr. Tell proposed reviewing the C95.3 standard and identifying those areas that require updates or revisions. 6. Presentation on "Uncertainties Associated with the Near Field Equation". Mr. Ric Tell gave a presentation on the uncertainties associated with the near field equation, 4P/A. Mr. Tell mentioned that there exists data [see John Brewer and George Kizer] that suggest that the constant "4" in the equation could actually have a large variability depending on the antenna geometry and the antenna illumination taper. The SC-1 members agreed that it appears that the near field equation does vary with illumination. Presently, action was postponed on this topic due to an inability to acquire the original research documents that produced the original equation. Unapproved Minutes – 12 January 2016 TC95 Meeting ATTACHMENT 12 7. Mr. Marv Wessel discussed RF measurement uncertainties highlighting FCC enforcement bureau techniques utilized during regulatory inspections of wireless locations. Factors that affected the RF measurement uncertainties included: a. Variations in the field intensity in close proximity of the emitter antennas. b. The emitter's varying duty cycle and the variable sampling rate during RF measurements. c. The physical of size of the RF probes and the probe placement relative to the emitter's antenna. d. The unclear regulatory guidance pertaining to performing RF measurements. 8. There were no new business topics brought up. 9. The date and location of the next SC-1 meeting is scheduled for June 2, 2016 somewhere in Ghent, Belgium. 10. The meeting was adjourned on June 10, 2016 at 11:55 AM. Unapproved Minutes – 12 January 2016 TC95 Meeting HIGHLIGHTS of Minutes SC2 – Plantation, FL; ATTACHMENT 13 Sunday, 10 January 2016; 1300 - 1700 h CTO by Chair, R. Tell at 13:10; 24 in attendance. Discussions on: o The Minimal information/training to qualify for exposure up to upper tier (M. Butcher) o Implications of the lack of RF safety program including sample FCC NAL. A discussion ensued with the nuances of the signs / barriers being a COMPONENT of an RF Safety Program, or where the signs / barriers ARE the RF Safety Program. (M. Wessel) o RF Minimal Awareness Guide. Discussion that an RF Safety Program needs to be maintained to be effective. Review the language of C95.1 with the definition of RF restricted area. ACTION ITEM: R. Tell to circulate RF Minimal Awareness Guide to ADHOC group. The need for different warning signs for low frequency (< 3 kHz) electric and magnetic fields? o Static fields signs supplied by MRI/NMR manufacturers? o We have the “no touch” sign in C95.2, but R. Tell pointed out that this is a CNS issue, and not a touch/burn issue. o ACTION ITEM: R. Tell to circulate ideas or even the need for different low frequency signs to an ADHOC group. Specific recommendations for training opportunities for SC-2? New Business o Discussion of installing barriers with 6’ of the edge of the roof, where the fall hazard is more prevalent than the RF hazard. o The PAR for revising C95.2 has expired. SC2 can sponsor a ballot to IEEE/SA membership for renewal similar to the process of reaffirmation. R. Tell suggested we renew C95.2 with new signs for LF fields. ACTION ITEM: R. Tell to decide what to do about C95.2. o We need to attract attendees of SC2 at the meeting. Perhaps each SC could present special topics workshop? Reach out through IEEE membership locally in EU and provide training opportunities for SC-2, or specific recommendations. Time and Place of Next Meeting: No decision yet if SC2 will meet. Adjournment at 16:00. Unapproved Minutes – 12 January 2016 TC95 Meeting ATTACHMENT 14 Ray Harmon Co-Chair Tamera Hay Co-Chair 1. 2. 3. 4. Meetings (Telecon 23 Apr 2015/11 Jan 2016) Subcommittee Members Status of C95.4-2002 Briefings 1. Issues/Concerns of Present Military Standards Related Fuels (R.Tell) 2. Military Standards HERO (R. Harmon) 5. Next Meeting (Jun 2016 Ghent, BE) Approved 11 Nov 2002 Reaffirmed 2008 Revision process needs to be complete and submitted to RevCom for consideration by Oct 2018 deadline for IEEE-SASB Dec 2018 meeting Develop PAR Ray Harmon Tamera S. Hay Vice President Science and Engineering, Systems Engineering & Information Solutions (SEIS) D 1-540-663-9348/C 1-540-379-5636 ray.harmon@aecom.com AECOM 16156 Dahlgren Road, Dahlgren, Virginia 22448 T 1-540-663-9300/F 1-540-663-9488 www.aecom.com RADHAZ Environment Characterization Group Lead HERP/HERF RADHAZ Certifications E3 Assessment & Evaluation Branch NSWC Dahlgren/Code Q52 5493 Marple Rd, Suite 156 Dahlgren, VA 22448-5100 COMM: 540 653-1419 FAX: 540 653-7494 NIPR: tamera.hay@navy.mil Unapproved Minutes – 12 January 2016 TC95 Meeting ATTACHMENT 15 11 January 2016 Motorola Solutions, Inc. Florida, USA IEEE/ICES TC95 SC6: Update Akimasa Hirata* Chair, SC6 of IEEE ICES TC95 LF Research Agenda (1) Modeling of in-situ fields induction from externally applied EMF or electric current A.1. Measurement of Tissue Conductivity A.2. Modeling of skin, muscle, and CNS tissue A.3. Numerical Artifacts A.4. Spatial averaging A.5. Diversity of induction models among investigators A.6. .Synaptic effects A.7. Validation ICES 2016 Plantation, USA January 12, 2016 Slide 2 IEEE ICES LF Research Agenda (2) ES modeling B.1. Target tissue representing the PNS B.2. dE/dx vs. E magnitude B.3. Consistency of excitation models B.4. Waveform sensitivity B.5. Modeled organ B.6. Type of neuron B.7. Synapse model for CNS interactions B.8. General availability B.9. Computational artifacts B.10. Validation ICES 2016 Plantation, USA January 12, 2016 Slide 3 IEEE ICES LF Research Agenda (3) Issues related to exposure limits C.1. Target tissue representing the PNS C.2. Consistency of induction model for BR vs. RL/MPE determination C.3. Induction model specificity C.4. Reduction Factors applied to RLs C.5. dE/dx vs. E magnitude C.6. Compliance tests for nonsinusoidal waveforms C.7. Induction plus excitation model structure C.8. Statistical models of reaction thresholds ICES 2016 Plantation, USA January 12, 2016 Slide 4 IEEE ICES LF Workshop (1) 0830 – 1640 h Sunday, 14 June 2015 Chapel Hall, Asilomar Conference Center Pacific Grove, California, USA Opening Remark “Rationale behind EMF Compliance Assessment Protocols,” Andreas Christ (Research Consultant, Cabo Frio (RJ), Brazil ) and Jafar Keshvari (Microsoft Corporation, EMF Research and Standards, Espoo, Finland ) “Measurement of dielectric characteristics of biological tissues from ELF to MMW frequencies,” Kanako Wake, Kensuke Sasaki, and Soichi Watanabe (National Institute of Information and Communications Technology, Tokyo, Japan ) “The role of skin modelling in ELF/LF magnetic field exposure assessment based on IEEE C95.6 and ICNIRP 2010,” Schmid Gernot (Seibersdorf Laboratories, Austria ) “Review of ELF/LF dosimetry for magnetic field exposure in Japan,” Kenichi Yamazaki (CRIEPI, Yokosuka, Japan ICES 2016 Plantation, USA January 12, 2016 Slide 5 IEEE ICES LF Workshop (2) “Modeling of transcranial Electrical Stimulation (tES): Implications for Safety and Efficacy,” Dennis Truong and Marom Bikson (City College New York, USA ) “Survey of Electrostimulation models,” J Patrick Reilly (Metatec Associates, USA) “Magnetophosphene perception threshold in humans exposed to ELF MF up to 50 mT – experimental data and a modelling approach,” Alexandre Legros (Lawson Health Research Institute, Canada) “Insights on human response to EMF exposure obtained by combining detailed anatomical induction models and modern neuronal dynamics models,” (IT’IS Foundation, Switzerland ) “Multi-scale induction and electrostimulation model with experimental validation,” Ilkka Laakso and Akimasa Hirata (Nagoya Institute of Technology, Japan) Discussion on Future Research Topics Participants; 82 + ICES 2016 Plantation, USA January 12, 2016 Slide 6 IEEE ICES Some papers are solicited from the talks presented at the IEEE International Committee on Electromagnetic Safety Workshop held in June 2015 (Monterey, USA). ICES 2016 Plantation, USA January 12, 2016 Slide 7 IEEE ICES RF Research Agenda Editorial Committee Members: Akimasa Hirata (Nagoya Inst. Tech., Japan) Ilkka Laakso (Aalto Univ., Finland) Kenneth Foster (Univ. Pennsylvania, USA) Marvin Ziskin (Temple Univ., USA); SC4 ICES 2016 Plantation, USA January 12, 2016 Slide 8 IEEE ICES Tentative Table of Contents (1) Electromagnetic Dosimetry A.1. Measurement of dielectric constants and its modeling A.2. Computational uncertainty A.3. Dosimetry modeling at higher frequencies A.4. Modeling of heat sensitive tissues A.5. Validation ICES 2016 Plantation, USA January 12, 2016 Slide 9 IEEE ICES Tentative Table of Contents (2) Thermal Dosimetry B.1. Measurement of thermal constants and its modeling B.2. Modeling of core temperature B.3. Stair-casing Error B.4. Modeling of thermophysiology including age dependency B.5. Modeling of heat sensitive tissues B.6. Validation ICES 2016 Plantation, USA January 12, 2016 Slide 10 IEEE ICES Tentative Table of Contents (3) Items related to Limits C.1. Threshold for skin sensation C.2. Averaging Time C.3. Averaging volume of SAR C.4. Averaging area of power density (over GHz region) C.5. Upper and lower frequencies of SAR C.6. Issues related to product safety ICES 2016 Plantation, USA January 12, 2016 Slide 11 IEEE ICES Schedule 1st draft: February-March Circulated to ICES SC6 Members Discussed at ICES June 2016 Meeting ICES 2016 Plantation, USA January 12, 2016 Slide 12 IEEE ICES Unapproved Minutes – 12 January 2016 TC95 Meeting ATTACHMENT 16 1 ICES Analysis Contents 1. 2. 3. 4. 5. Website Analytics Charts (January 1st – December 31st) .............................................................. 2 Website Analytics Summary & Comparison ................................................................................. 2 Traffic Sources (January 1st – December 31st) ............................................................................... 2 Top Referral Sites (August 1st – October 26th) .............................................................................. 2 Top Search Terms (October 8th – January 5th)............................................................................... 3 2 1. Website Analytics Charts (January 1st – December 31st) Top 10 Pages Pageviews 1 Unique Visitors Home Page 3,458 1,627 Electromagnetic Energy Facts, and a Qualitative View 1,363 1,099 Expert Reviews 721 385 TC95 582 344 TC34 383 213 Standards 346 269 About Us 320 197 Meetings 300 178 News 298 88 Reports 223 143 2. Website Analytics Summary & Comparison January 1 – December 31st 2015 January 1st – December 31st 2014 % Change st Pageviews 12,554 Unique Visitors 4,020 Sessions 2 5,518 10,176 2,485 3,231 +23.37% +61.77% +70.78% 3. Traffic Sources (January 1st – December 31st) Direct Referral Search Percentage 20.5% 14.3% 65.2% 4. Top Referral Sites (January 1st – December 31st) Sites Intranet.nema.org Standards.ieee.org emfandhealth.com grouper.ieee.org facebook.com Pageviews 491 335 233 230 109 Sessions 147 141 138 87 51 1 Pageviews: The total number of pages viewed. Repeated views of a single page are counted. 2 Sessions: The period time (not greater than 30 minutes) a user is actively engaged with your website. 3 ieee-emf.com emfguide.itu.int 96 57 5. Top Search Terms (October 8th – January 5th) Keyword Electromagnetic energy facts Facts about electromagnetic energy Electromagnetic energy fun facts Ieee 1528 Jafar keshvari Ieee c95.1 Electromagnetic safety Iec 62209 Ices standards Ieee c95 # (Clicks) 247 107 13 13 7 7 7 5 5 49 29 30