DENISE CLEGHORN BOSTON SCIENTIFIC CORP. 1 BOSTON SCIENTIFIC PLACE M/S A15 NATICK MA USA W: (508)

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1 Subcommittee E10.01 on RADIATION PROCESSING: DOSIMETRY AND APPLICATIONS E10 Staff Manager JOE KOURY CHAIRMAN VICE CHAIRMAN VICE CHAIRMAN JOHN R. LOGAR ETHICON, INC. P.O. BOX 151, RT 22 WEST SOMERVILLE, NJ USA W: (908) Secretary JOHN RICKEY DENISE CLEGHORN BOSTON SCIENTIFIC CORP. 1 BOSTON SCIENTIFIC PLACE M/S A15 NATICK MA USA W: (508) denise.cleghorn@bsci.com Balloting ROD CHU JOHN A. WILLIAMS BAXTER HEALTHCARE RLT-12 ROUTE 120 & WILSON ROAD ROUND LAKE, IL (847) JOHN_A_WILLIAMS@BAXTER.COM Education and Promotion EMILY CRAVEN PROGRESS REPORT 72 March 2012 TO: Subcommittee Members, Industry Groups FROM: John R. Logar, E10.01 Chairman I. E10.01 Updates 1. Executive Summary 2. January 2012 Subcommittee Meeting Attendees 3. Next Meeting 4. E10.01 Completed Standards 5. How to Obtain Copies of our Standards 6. Personal Notes 7. Membership Information 8. Specific Action on Standards 9. ISO Actions 10. Previous Meetings 11. Future Meetings II. III. IV. INDUSTRY UPDATES 1. AAMI 2. RPSMUG 3. CIRMS 4. iia 5. The Panel 6. Courses and Workshops 7. Upcoming Events 8. Books of Interest APPENDICES A January 2012 Meeting Action Items B New Committee Structure C June 2012 Preliminary Agenda ATTACHMENTS A Membership List

2 E10.01 UPDATES 1. EXECUTIVE SUMMARY MEETING MINUTES: The January 28 th February 1st, 2012 meeting in Atlanta, GA was held in conjunction with the ASTM committee week. The January 2012 meeting was attended by a total of 34 E10.01 members over the three day meeting. The meeting consisted of task group breakout sessions that included work on 11 standards in revision. This Progress Report will serve as the minutes for this meeting. Highlights from the meeting follow. NEW COMMITTEE: Prior to giving an update on the meeting, I want to share some exciting news about our subcommittee. As most of you are aware, the executive team from E10.01 made a proposal to ASTM and Committee E10 to move our group from being a subcommittee within E10 to being a full committee within ASTM. The new committee structure was presented during the Atlanta meeting and can be found in Appendix D to this Progress Report. The new committee is proposed to have 5 subcommittees where our current task groups would remain the same and report through one of the five subcommittees. The process to form a new committee entails the following: Approval from the E10 Executive Committee, Approval from the E10.01 Subcommittee, Approval from ASTM s Committee on Technical Committee Operations (COTCO) and finally approval from the ASTM Board of Directors. I am pleased to inform the membership within E10.01 that we received approval from three of the four groups with only the Board of Directors left to approve. Following approval from the Board of Directors, we will move forward in creating the new committee. In anticipation of being approved, during the subcommittee meeting in Atlanta, we held nominations for the new committee executive team. These nominations were contingent on gaining approval. Following the final approval, we will be sending out a ballot to all current subcommittee members requesting their vote on the new executive team. The following individuals were nominated and approved at the meeting for the following positions: John Logar Denise Cleghorn John A. Williams John Rickey Chairman 1 st Vice Chair 2 nd Vice Chair Secretary These individuals are currently holding the same roles within the current E10.01 subcommittee. Following the ballot, the new executive team will appoint members to lead each of the five subcommittee as well as key executive team positions such as leaders of Education and Promotion, Terminology and ISO Liaison. If all goes as planned, the new committee will be officially announced following the June 2012 meeting in San Diego. Details on a meeting format and subcommittee breakouts determined in the next few months suggestions are welcome. This move is a testament to the hard work, dedication and resolve that the membership of this subcommittee continues to show every year. I thank you for all you have done and all that you will do in the future. Our future is bright and with your assistance, I firmly believe we will continue to grow this new committee as well as the focus on the Radiation Processing industry. ISO AFFILIATION During the meeting in Atlanta, the group discussed at length our current affiliation with the ISO organization and the future status of our joint standards. The discussion was prompted by the numerous communication issues we have with our ISO resulting in a lengthy delay between ASTM approval and ISO approval. In addition to the communication issues, the review cycle is different for each organization; ASTM is 5 years and ISO is 3 years. Many members spoke up and commented on the fact that the industry will use good

3 standards regardless of where they come from. Following the conversation, a straw poll was taken and almost everyone in the room agreed we should drop our affiliation with ISO. We are in discussion with ASTM in regards to the agreement with ISO in order to determine our options. Stay tuned. Please contact me if you have concerns regarding our standards loss of affiliation with ISO at Jlogar8@its.jnj.com. UPDATE ON THE 7 TH WORKSHOP ON DOSIMETRY: The third announcement for the 7 th International Workshop on Dosimetry for Radiation Processing scheduled for June 24-28, 2012 was released earlier this month. We currently have 15 sponsors for the workshop and I would like to acknowledge and thank them for their support. The sponsors are, Aerial, Baxter, BD, Boston Scientific, Ethicon, Far West, GEX, Harwell, IBA, Mediline, Nordion, Sterigenics, Steris and Synergy Health. The workshop organizing committee is currently making a final push to increase the registration numbers and is vigorously working toward finalizing the workshop materials. In addition, the team is also looking for Individuals or vendors interested in submitting a poster or participating in the dosimetry system demonstrations. If you are interested, please contact the Poster Session Chair Peter Sidereas (peter_sidereas@steris.com). Registration information can be located at the following site: Additional information about the workshop is available from Symposium Chairmen Deepak Patil, Steris-Isomedix Services, Libertyville, IL, Deepak_patil@steris.com, or John A. Williams, Baxter Healthcare Corporation, Round Lake, IL, john_a_williams@baxter.com. E10.90 / E10 MEETING HIGHLIGHTS Staff Report Finances: E10 funds $26,303.83, E10.01 $25, New Members / Termination List (After 5 missed ballots, members will be automatically dropped, and the member must request to be allowed to vote. Their membership continues, only the opportunity to vote is removed). Reminder to please register your vote. Abstain if needed. We have five (5) E10.01 members on the delinquent list that have been contacted. Minutes can be found on the ASTM Committee E10 page. Subcommittee presented its rationale for moving the subcommittee out of E10 to form a new committee within ASTM. E10.01 FUNDING The current balance of funds for our subcommittee is just over $25,000. These funds enable us to continue to sponsor key individuals to come to meetings and support our standards development. In addition, we continue to support non-profit industry organizations and workshops that promote and use ASTM E10.01 standards. In the past six months we have sponsored the following non-profit meetings: CIRMS 2011 Annual Meeting Organizational Member & Student Sponsor Key individual travel support for semi-annual meeting and ISO/TC 85 Meeting in Paris In the next six months we are sponsoring the following non-profit industry events: Texas A&M University 2012 Hands-On Workshop in E-Beam and X-Ray Irradiation Technologies Meal Sponsor Key individual travel support for semi-annual meeting We will continue to monitor industry events and look for ways to support those that support us. Many ideas have been passed to us regarding ways to use the subcommittee funds including, test method development and future sponsorship. If you have any suggestions for sponsorship or need assistance with funding to an upcoming meeting, please reach out to me at Jlogar8@its.jnj.com. MANAGEMENT TASK GROUP UPDATES ADMINISTRATION Vice-Chairs: Denise Cleghorn, John Rickey Please take the time to review the updated membership list in Attachment A. If you need any changes made to your personal information, please log into ASTM and make the changes in their system. If you have membership questions, please contact John Logar at Jlogar8@its.jnj.com.

4 The Task Group Affiliation matrix is available from John Rickey and it is your responsibility to ensure it is up to date. If you need to make changes or have questions regarding the matrix, or would like a copy of the workbook, please contact John Rickey at rickey@fwt.com. In addition, E10.01 Progress Reports are on the Website under subcommittee minutes. The task group is keeping up to date with requested information and links that should be on the ASTM E10 webpage. If you need any changes or links added to the website that pertain to E10.01 please contact Denise Cleghorn at denise.cleghorn@bsci.com. BALLOTING Chair: Rod Chu Vice-Chairs: Kishor Mehta, Ryan Tracy, and Fred Halperin The restructuring of the standards with the new E 2628 as the top document requires most of the standards to have major revisions. For the balloting of standards, the maintenance procedures in ISO/TC 85 N 928 must be followed. ASTM standards are balloted following the procedures in the ASTM Green book. Each Task Group Chair is responsible for providing a document suitable for direct submission to ASTM for balloting. This ASTM version is a red-lined version showing the changes or, if the changes are extensive, a clean copy with an explanation of the major changes. If the document is to be balloted by ISO, a clean version in the ISO format is needed. For each standard that is to be balloted, a Management Task Group member is assigned to work with the Task Group Chair to ensure that common templates and definitions are used and that editorial errors are minimized. For standards, the Management Task Group member will also work with the ASTM editor during the conversion of the document into the ISO format. EDUCATION & PROMOTION Chair: Emily Craven Vice-Chair: Charlotte Rambo This Management Task Group was actively looking for a sub-committee member to lead this important MTG. During the meeting in Atlanta, Emily Craven (Nordion) was nominated and approved to lead this Management Task Group. This task group is responsible for promoting the subcommittee, future workshops and to look to create additional training sessions that can be implemented for the industry. If you have suggestions for the Management Task Group, do not hesitate to contact me at Jlogar8@its.jnj.com or Emily Craven at Emily.Craven@nordion.com. TASK GROUP CHAIR RESPONSIBILITIES POLICY REMINDER AS A REMINDER we are in a very busy time with almost all of our standards under some type of revision, we need to move standards along through the review periods and ballot process in a timely and effective manner. The task group chair must make every effort to get updated drafts and comments out to the task group and/or subcommittee in plenty of time as to provide an adequate review and comment period. In addition, all changes to a draft standard must be completed at least THIRTY DAYS prior to meeting in order to give task group members enough time to adequately prepare for the meeting and subsequent breakout sessions. Also, ASTM will send out a comments page when the standards go out to subcommittee, and similar to ISO comments, it will include a column to identify comments as Technical (T) or Editorial (E). All members will be required to submit comments on this form; this will help with the consolidation and review of comments. As we move through the revision process, we must also be sure the definitions section of each standard is up to date with what is in our E10.01 Glossary. The glossary was recently sent out to all of the TG chairs and it is your responsibility to ensure the definitions are updated as required. If you did not receive a copy of the glossary, please let me know and I will ensure you get a copy. It is the ultimate responsibility of the Executive committee to make sure that things move forward efficiently but we rely on the task group chairs to be the main driver. For comments or suggestions on these policies, please contact John Logar at Jlogar8@its.jnj.com. CONSOLIDATION OF EXISTING STANDARDS - REMINDER The combination of two existing standards, 51204: Practice for Dosimetry in Gamma Irradiation for Food Processing with 51702: Practice for Dosimetry in Gamma Irradiation Facility for Radiation Processing is complete. The new revision of was balloted this spring at the main committee level and approved. It is now moving to the ISO approval process. At the same time, was withdrawn in the ASTM system and will be balloted for withdrawal in the ISO system. In addition, 51431: Practice for Dosimetry in Electron Beam and X-ray (Bremsstrahlung) Irradiation Facilities for Food Processing is currently being consolidated with 51608: Practice for

5 use of Dosimetry in an X-ray (Bremsstrahlung) Facility for Radiation Processing and 51649: Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies between 300 kev and 25 MeV. If you have any questions or concerns on this effort, please contact John Logar at CHANGES IN E10.01/NEW COMMITTEE The subcommittee is preparing to go through the ultimate change as we take the next step to become a new committee. This is a very exciting time but it also a time of uncertainty. Now, more than ever, is the time we need our current membership to step up and take on more responsibility. As we look to break up our task groups into multiple subcommittees, the need for new leaders is greater than ever. The success of the new committee is dependent on this new set of leaders and their vision. We are continually looking for new members to take on responsibility and get more involved. I pledge to those who do volunteer and are unfamiliar with the process, we will provide guidance and support as you become more familiar with the responsibility. Your success is our success. If you are interested in learning more about how you can play more of an active role within the new committee, please contact John Logar at Jlogar8@its.jnj.com. VERTICAL MODALITY STANDARDS ALIGNMENT The subcommittee, led by Arne Miller, discussed aligning the application standards with ISO Working group TC198 is pursuing a major revision of Part 3. It would be very useful if we revise our Application Standards (Gamma, e-beam and X-ray) to follow the flow of and provide adequate details to ensure users can meet the requirements of the ISO standards through our standards. This would enable the revision of Part 3 to directly refer to our standards. In addition, the information provided in these standards would enable the user to properly characterize their irradiation systems. This characterization is essential to adequately assessing process variability and ultimately establishing process parameters and controls. NEW TASK GROUP ON POLYETHYLENE DOSIMETER Following a proposal in Baltimore a year ago, a decision was made to not pursue a new task group and standard on the use of Polyethylene as a new dosimeter. The decision was based on the lack of resources needed to drive the task group and standard development. ACTION ITEMS During the meeting the group reviewed the action items list from the last meeting in June 2011 in Montreal. Items that remained opened were transferred to the new list from the Atlanta meeting. Following the three-day meeting in Atlanta, a total of 22 action items were identified. The Action Item list can be found in Appendix A of this report. Please ensure the tasks you have responsibility for are being tracked and you stay on target for the expected completion date. COPIES OF DRAFT STANDARD Progress Report 72 does not contain any draft standards. Please contact your Task Group Chair or the Subcommittee Chair directly to obtain a current copy. For the next Subcommittee meeting, please ensure that you have an updated copy of the standards on which you will be working. Please contact John Logar at Jlogar8@its.jnj.com or Joe Koury at jkoury@astm.org for additional information. RECENT ASTM BALLOT RESULTS For more information on the name and status, refer to the tables and updates in Section 8: Specific Actions on Standards. If necessary, contact the TG Chair directly. The ballot results are summarized. MAIN COMMITTEE BALLOT E10 (11-03) September 8, 2011 to October 8, 2011 Reapproval of ASTM E Practice for Use of a Lif Photo-Fluorescent Film Dosimetry System SUBCOMMITTEE BALLOT E10.01 (11-02) November 14, 2011 to December 14, 2011 Affirmatives Negatives Abstentions % Affirmatives Negatives Abstentions %

6 Revision of 51275:2004 Practice for Use of a Radiochromic Film Dosimetry System Revision of 51649:2005 Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies Between 300 and 25 MeV Revision of 51818:2009 Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies Between 80 and 300 kev Revision of 51650:2005 Practice for Use of a Cellulose Triacetate Dosimetry System ISO BALLOTS ON OR ASTM STANDARDS Standard Ballot Start Date DIS ballot for major revision DIS Practice for Use of a Polymethylmethacrylate Dosimetry System Practice for Use of a Radiochromic Liquid Dosimetry System Practice for Use of a Radiochromic Optical Waveguide Dosimetry System Guide for Dosimetry for Sterile Insect Release Programs Practice for Calibration of Routine Dosimetry Systems for Radiation Processing Practice for Dosimetry in a Gamma Irradiation Facility for Radiation Processing Practice for Use of Calorimetric Dosimetry Systems for Electron- Beam Dose Measurements and Dosimeter Calibrations Practice for Dosimetry for a Self-Contained Dry-Storage Gamma-Ray Irradiator Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies Between 80 and 300 kev 51650:2005 Practice for Use of a Cellulose Triacetate Dosimetry System 51275:2004 Practice for Use of a Radiochromic Film Dosimetry System 51649:2005 Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies Between 300 and 25 MeV ASTM E2628 Practice for Dosimetry in Radiation Processing Systematic review Systematic review To ISO/TC 85 for approval and comment To ISO/TC 85 for approval and comment To ISO/TC 85 for approval and comment To ISO/TC 85 for approval and comment To ISO/TC 85 for approval and comment To ISO/TC 85 for approval and comment To ISO/TC 85 for approval and comment To ISO/TC 85 for approval and comment To ISO/TC 85 for approval and comment To ISO/TC 85 for approval for addition to standards Close Status Date 09/14/11 02/14/12 Approved by ISO ; 12 out of 12 in favour 11/02/11 03/15/12 In ballot 11/02/11 03/15/12 In ballot 09/25/10 11/25/10 Approved for ballot as DIS 09/25/10 11/25/10 Approved for ballot as DIS 09/25/10 11/25/10 Approved for ballot as DIS 09/28/10 11/28/10 Approved for ballot as DIS 09/28/10 11/28/10 Approved for ballot at DIS 01/20/12 03/20/12 In ballot 01/20/12 03/20/12 In ballot 01/20/12 03/20/12 In ballot 01/20/12 03/20/12 In ballot 09/29/10 11/29/10 Approved for ballot as DIS

7 ASTM E2701 Guide for Performance Characterization of Dosimeters and Dosimetry Systems for Use in Radiation Processing To ISO/TC 85 for approval for addition to standards 09/29/10 11/29/10 Approved for ballot as DIS FUTURE ASTM BALLOTS: Deadline Dates: 1 st Main or Concurrent Ballot March 21, nd Subcommittee Ballot April 16, nd Main or Concurrent Ballot May 10 th, 2012 Agendas for June Meeting May 19 th, 2012 As a reminder, a ballot can be generated at anytime; however the timing when the results will be ready is affected by when they are submitted. Please submit all drafts to Rod Chu a minimum of 7 days prior to the ballot date for preparation. For questions on balloting please contact John Logar at Jlogar8@its.jnj.com or Rod Chu at rodchu@rogers.com. 2. ATTENDEES at the January 2012 SUBCOMMITTEE MEETING Front Row: Fred Halperin, Shi-Shen Yau, Fatima Hasanain, Emily Craven, Pat Weixel, Roberto Uribe Second Row: Larry Nichols, Hans Wiegert, Kishor Mehta, Kim Morehouse, Denise Cleghorn, Peter Sharpe, John Rickey Third Row: Deepak Patil, Art Heiss, Arne Miller, Mike Pageau, Mark Bailey, Glenn Calvert, Josef Mittendorfer Back Row: John Logar, Herve Michel, Peter Sidereas, Jon Jannson, John Williams, Arnie Herer, Jimmy McGowan, Mike Swain, Rod Chu

8 ATTENDEE AFFILIATION: Mark Allen, Orthoplastics, Ltd. Arne Miller, RISO Mark Bailey, NPL Josef Mittendorfer, Mediscan Glenn Calvert, BD Medical Alan Montgomery, BD Medical Rod Chu, Consultant Kim Morehouse, US FDA Denise Cleghorn, Boston Scientific Larry Nichols, Nutek Corp Marsh Cleland, IBA Industrial Mike Pageau, GEX Corp Emily Craven, MDS Nordion Deepak Patil, STERIS Fred Halperin, J&J SPT David Pymer, Harwell Dosimeters Fatima Hasanain, MDS Nordion John Rickey, FWT Art Heiss, Bruker Biospin Peter Sharpe, NPL Arnold Herer, IBA Industrial Peter Sidereas, STERIS Jon Jannson, Baxter Healthcare Mike Swain, E-beam Services Joe Koury, ASTM Roberto Uribe, Kent State University John Logar, Ethicon Pat Weixel, US FDA Jimmy McGowan, Ethicon Hans Wiegert, Cryovac Kishor Mehta, Consultant John A. Williams, Baxter Herve Michel, LEONI Studer Shi-Shen Yau, Stryker GROUP OUTING ATLANTA: On Wednesday afternoon following the task group break outs for the day, a few members took advantage of the free afternoon and one group visited the Georgia Aquarium and a separate group visited the World of Coca- Cola. In spite of the rain, both groups enjoyed themselves and got to see well known Atlanta attractions. We will continue to solicit ideas and suggestions and explore group outing opportunities for each upcoming meeting. It is good to get out and do something fun with fellow industry colleagues (i.e. E10.01 members) outside the normal meeting settings. Please forward any suggestions for future meetings to Denise denise.cleghorn@bsci.com. 3. NEXT MEETING E10.01 MEETING - THURSDAY, JUNE 28 TH - FRIDAY JUNE 29 TH, 2012 There is no cost to attend this meeting; however, you must pre-register for this meeting (see below). If you are interested, you may join the workshop poster session social on Wednesday night and the Workshop banquet on Thursday night for a nominal fee. This is a great way to interact with the workshop participants and meet the next generation of our group. You must register and pay for these two activities when you register for the subcommittee meeting so we can plan appropriately. The E10.01 meeting will begin at 8:30 am sharp each day and will incorporate reports on sub-committee activities, E10 main committee activities, updates from industry organizations as well as updates from task group chairs on current active standards. Individual task group meetings will follow a daily group meeting. MEETING AGENDA The Preliminary Agenda for the meeting is attached in Appendix B. The Final Agenda will be issued prior to the next meeting. Suggestions, comments or additions should be sent to John Logar at Jlogar8@its.jnj.com. REGISTRATION Registration is required for all E10.01 meetings to ensure we have ample meeting space and enables us to properly prepare for the meeting. Registration is done through the ASTM website at via the meetings link. The meeting registration for subcommittee E10.01 is found under the E10 committee link. For questions or assistance on registering, please contact John Logar at Jlogar8@its.jnj.com

9 INDUSTRY PRESENTATIONS Due to shortened meeting this June, there will be no time slots for industry presentations during this meeting. SOCIAL PLANS Due to the shortened meeting, there will be no planned social activity during this meeting. The executive committee will be seeking suggestions for a group outing for the January 2013 meeting in the Jacksonville area. Please forward any suggestion to Denise Cleghorn at denise.cleghorn@bsci.com. HOTEL INFORMATION Information for the San Diego Sheraton Hotel and Marina can be found at You can also check the ASTM website under the June meeting for Committee E10 for additional information 4. E10.01 STANDARDS NOW COMPLETED Subcommittee E10.01 has completed the following 36 standards: 51205:2009 Practice for Use of a Ceric-Cerous Sulfate Dosimetry System * 51261:2010 Guide for Selection and Calibration of Dosimetry Systems for Radiation Processing 51275:2004 Practice for Use of a Radiochromic Film Dosimetry System * 51276:2010 Practice for Use of a Polymethylmethacrylate Dosimetry System * 51310:2009 Practice for Use of a Radiochromic Optical Waveguide Dosimetry System * 51401:2011 Practice for Use of a Dichromate Dosimetry System 51431:2005 Practice for Dosimetry in Electron Beam and X-ray (Bremsstrahlung) Irradiation Facilities for Food Processing 51538:2009 Practice for Use of the Ethanol-Chlorobenzene Dosimetry System * 51539:2005 Guide for Use of Radiation-Sensitive Indicators * 51540:2009 Practice for Use of a Radiochromic Liquid Dosimetry System 51607:2004 Practice for Use of an Alanine-EPR Dosimetry System 51608:2005 Practice for Dosimetry in an X-Ray (Bremsstrahlung) Facility for Radiation Processing * 51631:2011 Practice for Use of Calorimetric Dosimetry Systems for Electron Beam Dose Measurements and Routine Dosimeter Calibrations 51649:2005 Practice for Dosimetry in an Electron-Beam Facility for Radiation Processing at Energies between 300 kev and 25 MeV 51650:2005 Practice for Use of a Cellulose Triacetate Dosimetry System * 51702:2004 Practice for Dosimetry in Gamma Irradiation Facilities for Radiation Processing 51707:2005 Guide for Estimating Uncertainties in Dosimetry for Radiation Processing 51818:2009 Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies between 80 and 300 kev 51900:2009 Guide for Dosimetry in Radiation Research on Food and Agricultural Products 51939:2005 Practice for Blood Irradiation Dosimetry * 51940:2004 Guide for Dosimetry for Sterile Insect Release Programs 51956:2005 Practice for Use of Thermoluminescence-Dosimetry (TLD) Systems for Radiation Processing * Practice for Dosimetry for a Self-Contained Dry-Storage Gamma-Ray Irradiator ASTM E Practice for Using the Fricke Reference Standard Dosimetry System ASTM E Guide for Selection and Use of Mathematical Methods for Calculating Absorbed Dose in Radiation Processing Applications ASTM E Guide for Absorbed-Dose Mapping in Radiation Processing Facilities ASTM E Practice for Use of a LiF Photo-Fluorescent Film Dosimetry System ASTM E Guide for Dosimetry in Radiation Processing of Fluidized Beds and Fluid Streams ASTM E Guide for Irradiation of Pre-packaged Processed Meat and Poultry Products to Control Pathogens and Other Microorganisms ASTM E Practice for Dosimetry in Radiation Processing

10 ASTM E Guide for Performance Characterization of Dosimeters and Dosimetry Systems for Use in Radiation Processing ASTM F Guide for Irradiation of Fresh Agricultural Produce as a Phytosanitary Treatment ASTM F Guide for Irradiation of Fresh and Frozen Red Meat and Poultry to Control Pathogens and Other Microorganisms ASTM F Guide for Selection and Use of Packaging Materials for Foods to be Irradiated ASTM F Guide for Irradiation of Finfish and Aquatic Invertebrates Used as Food to Control Pathogens and Spoilage Microorganisms ASTM F Guide for Irradiation of Dried Spices, Herbs, and Vegetable Seasonings to Control Pathogens and Other Microorganisms *Standards have been approved within ASTM and must go through the ISO balloting process and be approved via ISO prior to publication. 5. HOW TO OBTAIN COPIES OF OUR DOSIMETRY STANDARDS INDIVIDUAL STANDARDS Those wishing to purchase a copy of any ASTM or standard may obtain it by contacting the Customer Service Department, ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA , USA, by calling +1 (610) , or by faxing +1 (610) Customers and members may also download any standard (for a charge) from the ASTM website at This information is in the ASTM Store under ordering information or you may contact ASTM by at service@astm.org. ASTM accepts Visa, MasterCard and American Express. ASTM members receive a volume of standards free with their annual membership. For more information on standards, please contact the E10.01 staff manager, Joe Koury at jkoury@astm.org. COMPILATION OF DOSIMETRY STANDARDS REFERENCED IN ISO ASTM offers a compilation of 14 ASTM and standards that are directly referenced in ISO :2006. The goal of this compilation was to enable users of the ISO standard to purchase, at a discounted price of $99 per year, all the necessary ASTM related references to ISO and not have to worry about whether or not they had the most up to date copy. This set is also available for use in multiple sites at an additional cost please contact ASTM for details on multi-site licenses. The ASTM Stock Number is: STERIL PERSONAL NOTES Our staff manager, Joe Koury, was issued an award for his dedication and service to an E10 symposium held in May of Congratulations Joe on this honor. 7. MEMBERSHIP CURRENT MEMBERSHIP INFORMATION The updated Membership List can be found in Attachment A to this Progress Report. The membership list is also available in the Rosters section on your committee s page following login. This is not available without an annual ASTM membership and website password. Members are urged to review the data for accuracy. Corrections should be made directly through the ASTM website. Comments or suggestions should be sent to the E10.01 Secretary, John Rickey at rickey@fwt.com. TG CHAIR/VICE-CHAIR/VICE CHAIR OPENINGS Once again we are in need of individuals to fill TG Chair/Vice Chair openings. As the subcommittee continues to work and grow, we need new individuals to take on additional responsibility. This is a great opportunity to get involved and really make a difference in the development or revision of an industry standard. Your assistance and willingness to take on this responsibility contributes directly toward the success of our

11 subcommittee. If you are interested in becoming a chair or vice-chair for a specific standard, please contact John Logar at Jlogar8@its.jnj.com. DEADBEATS LIST Members are reminded that failure to vote on three consecutive ballots will result in the termination of your voting status in Subcommittee E10.01 unless the E10.01 Chair in conjunction with the E10 Executive Committee grants a waiver. All members are encouraged to review and vote on in ballots regularly. This ballot process is critical to the success of ASTM and the development of good standards. APPLICATION FOR ASTM MEMBERSHIP ASTM membership is not required for participation in subcommittee activities, but membership is needed in order to have a formal vote (and veto) when standards are balloted. The annual membership fee is $75 per year. Please note that this membership fee for joining ASTM includes a free subscription to the monthly ASTM magazine, Standardization News and a free volume of the Annual Book of ASTM Standards (normally costing $210 US). The Annual Book of ASTM Standards includes 155 completed standards on various subjects, including all of the E10.01 published standards. Along with the benefits of membership comes the responsibility to actively participate by voting on all ballots issued by Subcommittee E10.01 and Committee E10. Failure to meet the responsibility for three consecutive ballots will usually result in declassification and eventually the removal from our rosters. We strongly encourage you to actively participate and have your views fully considered by becoming a voting member of ASTM International. If you are not already a member of ASTM, please contact Joe Koury at jkoury@astm.org for further information or an application form. STANDARDS VOLUME With an annual membership, members are entitled to a volume of standards. The E10.01 standards can be found in ASTM Volume It is recommended that members sign up for the On-line Volume where you can download individual standards at anytime. The benefit from the on-line membership is that you will have access to the most recently published version of the standard as soon as it is published. With the CD volume or hardcopy volume you will receive the updated standards at the time the volume is published and may have to wait an entire year to get recently published standards. For questions on the various volume options, please contact John Logar at Jlogar8@its.jnj.com. 8. SPECIFIC ACTIONS ON STANDARDS The status of the 39 standards produced and maintained by ASTM Subcommittee E10.01 is summarized in Tables 1-5 below. At present E10.01 is responsible for maintaining 25 Dosimetry Standards, 7 ASTM Dosimetry Standards, 6 Food Irradiation Standards, and a Glossary of the terms used in the dosimetry standards. Updates on the activities of the active Task Groups are provided following the tables. TABLE 1: SUMMARY OF STATUS OF THE 25 DOSIMETRY STANDARDS STANDARD NAME TG CHAIR VICE-CHAIRS STATUS 51204: : :2002 Practice for Dosimetry in Gamma Irradiation Facilities for Food Processing Practice for Use of a Ceric- Cerous Sulfate Dosimetry System Practice for Calibration of Routine Dosimetry B Kim Morehouse John Logar, Kishor Mehta Original decision was to withdraw and include other products in This was revised to withdrawal of and revision of Withdrawal of approved by ASTM. Waiting for ISO ballot. Major revision of passed E10 ballot. Waiting for ISO DIS ballot. V Rod Chu Current edition approved June 18, 2008; published June R Brad Peter Sharpe, Being revised as major revision Lundahl Marc Desrosiers with title change. Passed E10 ballot.

12 51275: : : : : : : : : : : : : :2005 Systems for Radiation Processing (New Title) Practice for Use of a Radiochromic Film Dosimetry System Practice for Use of a Polymethylmethacrylate Dosimetry System Practice for Use of a Radiochromic Optical Waveguide Dosimetry System Practice for Characterization and Performance of a High-Dose Radiation Dosimetry Calibration Laboratory Practice for Use of a Dichromate Dosimetry System Practice for Dosimetry in Electron Beam and X-ray (Bremsstrahlung) Irradiation Facilities for Food Processing Practice for Use of the Ethanol-Chlorobenzene Dosimetry System Guide for Use of Radiation-Sensitive Indicators Practice for Use of a Radiochromic Liquid Dosimetry System Practice for Use of an Alanine-EPR Dosimetry System Practice for Dosimetry in an X-ray (Bremsstrahlung) Facility for Radiation Processing Practice for Use of Calorimetric Dosimetry Systems for Electron-Beam Dose Measurements and Dosimeter Calibrations Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies between 300 kev and 25 MeV Practice for Use of a Cellulose Triacetate Dosimetry System Waiting for ISO DIS ballot. U John Rickey Gary Pageau Being revised as a major revision. See update following Table 1. P Roger Bett Deepak Patil, Paul Mellor Major revision approved by ASTM. Waiting for results from recently completed ISO DIS ballot. ee John Rickey Mike Saylor Ballot for reapproval by ASTM was affirmative. Waiting for ISO ballot for reapproval. However, ISO has started a Systematic Review. C To be withdrawn. Approved by ASTM for withdrawal. Waiting for ISO ballot. D Peter Sharpe Rod Chu Major revision approved by ASTM. Waiting for ISO DIS ballot. A Q Kishor Mehta Dušan Razem Marsh Cleland To be withdrawn. Decision was made to combine with and ISO to be asked to ballot for withdrawal. András Kovács Current edition approved June 18, Published June E Mark Murphy Tom Menezes Being revised as major revision. See update following Table 1. K John Rickey Mike Saylor Ballot for reapproval by ASTM was affirmative. Waiting for ISO ballot for reapproval. However, ISO has started a Systematic Review. F Marc Art Heiss Being revised as a major revision. Desrosiers John Logar See update following Table 1. M Marsh Cleland Herve Michel Being revised as a major revision. See update following Table 1. H Arne Miller Mark Bailey Major revision approved by ASTM. Waiting for ISO DIS ballot. T W Josef Mittendorfer Mike Pageau Kishor Mehta Marsh Cleland Takuji Kojima Kishor Mehta Being revised as a major revision. See update following Table 1. Being revised as a major revision. See update following Table : :2005 Practice for Dosimetry in a Gamma Irradiation Facility for Radiation Processing Guide for Estimating Uncertainties in Dosimetry for Radiation Processing B Kim Morehouse John Logar Kishor Mehta G John Logar Kishor Mehta, Shi-Shen Yau, Brad Lundahl Major revision, combined with 51204, approved by ASTM. Waiting for ISO DIS ballot. Being revised as a major revision. See update following Table 1.

13 51818: : : : : :2002 Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies Between 80 and 300 kev Guide for Dosimetry in Radiation Research on Food and Agricultural Products Practice for Blood Irradiation Dosimetry Guide for Dosimetry for Sterile Insect Release Programs Practice for Use of Thermoluminescence Dosimetry (TLD) Systems for Radiation Processing Practice for Dosimetry for a Self-Contained Dry-Storage Gamma-Ray Irradiator L Gary Pageau Doug Weiss, Marsh Cleland, Arne Miller Current edition approved June 18, 2009; published June Work has already started on preparing a new revision. See update following Table 1. Z OPEN Kishor Mehta Current edition approved June 18, Published June X Paul Mellor Requires revision. See update following Table 1. cc Dave Lance Kishor Mehta Major revision approved by ASTM. Waiting for ISO DIS ballot. aa Rod Chu Dave Vehar Being revised as a major revision. See update following Table 1. N Paul Mellor Major revision approved by ASTM. Waiting for ISO DIS ballot. TASK GROUP A 51431: Practice for Dosimetry in Electron Beam and X-Ray (Bremsstrahlung) Irradiation Facilities for Food Processing Chair: Kishor Mehta Vice-Chairs: John Logar, Marsh Cleland Update: STANDARD to be WITHDRAWN. This standard will be incorporated into the Standards (Practice for Dosimetry in an X-Ray (Bremsstrahlung) Facility for Radiation Processing) and (Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies between 300 kev and 25 MeV), resp. The two relevant standards, and 51649, are both being revised currently. TASK GROUP B 51702: Practice for Dosimetry in a Gamma Facility for Radiation Processing Chair: John Logar Vice-Chairs: Alan Montgomery, Kishor Mehta Update: Revision of has passed ASTM Main Committee ballot. The approved draft was sent to ISO for ballot. TASK GROUP D 51401: Practice for Use of a Dichromate Dosimetry System Chair: Peter Sharpe Vice-Chair: Rod Chu Update: The standard has passed ASTM balloting and has been sent to ISO for balloting. TASK GROUP F 51607: Practice for Use of an Alanine-EPR Dosimetry System Chair: Marc Desrosiers Vice-Chairs: Art Heiss, John Logar Update: The latest draft was reviewed and updated following a negative vote during subcommittee balloting. The updated draft will be submitted for main committee ballot this spring. TASK GROUP G 51707: Guide for Estimating Uncertainties in Dosimetry for Radiation Processing Chair: John Logar Vice-Chairs: Kishor Mehta, Brad Lundahl, Shi-Shen Yau Update: The latest version created by the standard chairs was reviewed during the meeting in Atlanta. The task group break outs continued to be dominated by in-depth discussions surrounding uncertainty in our measurement systems and how we calculate and present the estimates. Numerous suggestions were made to improve the wording in the standard. Further updates will be made and the updated draft will go through a subcommittee ballot this spring.

14 TASK GROUP H 51631: Practice for Use of Calorimetric Dosimetry Systems for Electron Beam Dose Measurements and Routine Dosimeter Calibration Chair: Arne Miller Vice-Chairs: Fred Bateman, Mark Bailey Update: The revised standard has been approved by ASTM. Approved draft was sent to ISO for balloting. TASK GROUP L 51818: Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies Between 80 and 300 kev Chair: Gary Pageau Vice-Chairs: Doug Weiss, Marsh Cleland and Tom Menezes Update: The subcommittee ballot 2011 of this practice drew 2 negatives and a number of positives with comments. A revised version and chair s suggested resolutions of the comments were discussed at the meeting in Atlanta. The comments accompanying the negatives were resolved and the negative votes were withdrawn. The chair s suggested resolutions of other comments were approved with modifications, which included the need for modified figures. Following the meeting a final draft has been prepared and submitted for main committee ballot. All modifications of the draft were editorial, including new figure 4 that has been prepared with two Monte Carlo calculated depth dose distributions made by Jakob Helt-Hansen. TASK GROUP M 51608: Practice for Dosimetry in an X-ray (Bremsstrahlung) Facility for Radiation Processing Chair: Marsh Cleland Vice-Chairs: Herve Michel, Kishor Mehta Update: The 5-year review on this standard has begun. The task group is currently working on the next revision and including key food related sections from into the document. Comments were solicited prior to the Atlanta meeting and an updated draft was created based on the comments. This draft was reviewed during the Atlanta meeting and several edits were made. The chairs will continue soliciting the task group members for input and the draft revision will continue via an ASTM collaboration area. TASK GROUP N 52116: Practice for Dosimetry for a Self-Contained Dry-Storage Gamma- Ray Irradiator Chair: Paul Mellor Vice-Chair: OPEN Update: The revised standard has been approved by ASTM but still requires approval by ISO. TASK GROUP P 51276: Practice for Use of a Polymethylmethacrylate Dosimetry System Chair: Roger Bett Vice-Chairs: Paul Mellor, Deepak Patil Update: The revised standard has been approved by ASTM and ISO. The updated standard will published this spring. TASK GROUP R 51261: Practice for Calibration of Dosimetry Systems for Radiation Processing Chair: Brad Lundahl Vice-Chairs: Peter Sharpe, Marc Desrosiers, Arne Miller Update: The revised standard has been approved by ASTM. The standard is currently going through the ISO balloting process. TASK GROUP T 51649: Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies between 300 kev and 25 MeV Chair: Josef Mittendorfer, Kishor Mehta Vice-Chairs: Marsh Cleland, Peter Baker Update: Task Group T met for two sessions at the Atlanta Meeting. The primary focus was to discuss the 3 negative votes and other comments of the December 2011 sub-committee ballot. The remaining issue is the harmonization of the IQ, OQ and PQ sections of with ISO Work on this topic is in progress, which will lead to a new draft later this year. TASK GROUP U 51275: Practice for Use of a Radiochromic Film Dosimetry System Chair: John Rickey Vice-Chair: Gary Pageau, Mike Pageau Update: This standard is in its review stage and went to subcommittee ballot in December. The draft will be updated based on comments and will go to the next committee ballot.

15 TASK GROUP W 51650: Practice for Use of a Cellulose Triacetate Dosimetry System Chair: Mike Pageau Vice-Chairs: Takuji Kojima Update: TG-W (CTA) has a draft document that went through a sub-committee ballot last fall and the results were reviewed during the meeting in Atlanta. Minor edits were made and the standard will go through a main committee ballot this spring. TASK GROUP aa 51946: Practice for Use of Thermoluminescence Dosimetry (TLD) Systems for Radiation Processing Chair: Rod Chu Vice-Chair: Dave Vehar Update: This standard is up for review. Revision of the standard will begin in the autumn of 2011 and a first draft is expected to be available for comment this spring. TASK GROUP cc 51940: Guide for Dosimetry for Sterile Insect Release Programs Chair: Dave Lance Vice-Chair: Kishor Mehta Update: Revision has passed ASTM Main Committee balloting and is currently going through the ISO balloting process. TABLE 2: SUMMARY OF STATUS OF THE 7 ASTM E10.01 DOSIMETRY STANDARDS STANDARD NAME TG CHAIR VICE-CHAIRS STATUS ASTM E ASTM E ASTM E ASTM E ASTM E ASTM E 2628 ASTM E2701 Practice for Using the Fricke Reference-Standard Dosimetry System Guide for Selection and Use of Mathematical Methods for Calculating Absorbed Dose in Radiation Processing Applications Guide for Absorbed-Dose Mapping in Radiation Processing Facilities Practice for Use of a LiF Photo-Fluorescent Film Dosimetry System Guide for Dosimetry in Radiation Processing of Fluidized Beds and Fluid Streams Practice for Dosimetry in Radiation Processing Guide for Performance Characterization of Dosimeters and Dosimetry Systems for Use in Radiation Processing Y Peter Sharpe Rod Chu Current edition approved January 1, 2004; published February Due for 5-year ASTM Systematic Review. See update following Table 2. dd Roberto Uribe Doug Weiss, Mike Saylor, Bruce Peterson S Gary Pageau Glenn Calvert, Bruce Peterson gg bb Mark Murphy Denise Cleghorn Current edition approved July 1, 2010; published September Current edition approved July 1, 2011; published August 2011 András Kovács Originally approved in Current edition approved Nov. 1, Work has begun on a major revision. See update following Table 2. Doug Weiss Originally approved in Current edition approved Dec. 1, Published January hh Peter Sharpe OPEN Current edition approved August 15, 2009; published September Waiting for ISO DIS Ballot for addition to set of standards. ff Rod Chu OPEN Current edition approved July 15, 2009, published September Waiting for ISO DIS Ballot for addition to set of standards. Task Group Y ASTM E 1026: Practice for Using the Fricke Reference-Standard Dosimetry System Chair: OPEN Vice-Chairs: Peter Sharpe Update: Being reviewed under 5-year Systematic Review. Requires approval of revision by December 2012.

16 Task Group dd ASTM E 2232: Guide for Selection and Use of Mathematical Methods for Calculating Absorbed Dose in Radiation Processing Applications Chair: Roberto Uribe Vice-Chairs: Doug Weiss, Mike Saylor, Bruce Peterson Update: To be submitted to ISO for inclusion in set of standards. Task Group S ASTM E 2303: Guide for Absorbed-Dose Mapping in Radiation Processing Facilities Chair: Gary Pageau Vice-Chairs: Glenn Calvert, Bruce Peterson Update: The latest draft has been approved by ASTM. To be submitted to ISO for inclusion in set of standards. Task Group gg ASTM E 2304: Practice for Use of a LiF Photo-Fluorescent Film Dosimetry System Chair: Mark Murphy Vice-Chairs: András Kovács Update: Standard was Re-approved last fall. A major revision was submitted by the chairs and the changes were partially reviewed in Atlanta. The remainder of the changes will be reviewed via a collaboration area. The standard is on target for a subcommittee ballot this fall. Task Group bb ASTM E 2381: Guide for Dosimetry in Radiation Processing of Fluidized Beds and Fluid Streams Chair: Denise Cleghorn Vice-Chairs: Doug Weiss Update: Has been reapproved. To be submitted to ISO for inclusion in set of standards. Task Group ff ASTM E 2701: Guide for Performance Characterization of Dosimeters and Dosimetry Systems for Use in Radiation Processing Chair: Rod Chu Vice-Chairs: Open Update: To be submitted to ISO for balloting and inclusion in set of standards. Task Group hh ASTM E 2628: Practice for Dosimetry in Radiation Processing Chair: Peter Sharpe Vice-Chairs: OPEN Update: To be submitted to ISO for balloting and inclusion in set of standards. Addition of ASTM dosimetry standards to the group of 25 Dosimetry Standards: The new procedures for the addition of closely related dosimetry standards for which there is no counterpoint in ISO to the pilot project were finalized at the ISO/TC85/WG3 meeting in Orlando in June The new procedures (ISO/TC 85 Document N 1009) allow ASTM to submit published ASTM E10.01 standards to ISO/TC 85 for adoption as standards. The ASTM standard will be balloted by ISO/TC 85 as a Draft International Standard (DIS). TABLE 3: SUMMARY OF STATUS OF NEW STANDARDS BEING DEVELOPED BY ASTM E10.01 STANDARD NAME TG CHAIR VICE-CHAIRS STATUS E10.01 SPC Guide for Using Statistical Process Control Principles in Radiation Processing E10.01-J Practice for Use of a Label Dosimetry System I Mark Bailey Jon Jansson Peter Sharpe J Mark Murphy Zbigniew Zagorski, Gary Pageau See update following Table 3. No recent progress. Task Group I E10.01-I: Standard Guide for Using Process Control Principles for Routine Dosimetry in Radiation Processing Chair: Mark Bailey Vice-Chairs: Jon Jansson, Peter Sharpe, Brad Lundahl Update: Many task group break outs were utilized to continue the in depth discussions regarding this new ASTM standard. Differing viewpoints were discussed and the team worked toward common language for the body of the test. The team agreed the appendix to this standard should include numerous methods that may be used to establish

17 and monitor processes. A new draft is being circulated following the Atlanta meeting and when the chairs can agree to the wording for this standard, the standard will go to subcommittee ballot. This task group is utilizing an ASTM collaboration area so if you are not connected to this task group collaboration area, please contact Mark Bailey at mark.bailey@npl.co.uk. TABLE 4: SUMMARY OF STATUS OF TASK GROUP O TERMINOLOGY STANDARD NAME TG CHAIR VICE-CHAIRS STATUS E10.01-O Terminology Pertaining to Radiation Measurements and Dosimetry O Kishor Mehta Roberto Uribe, Marsh Cleland See update following Table 4. TASK GROUP O Terminology: Terminology Pertaining to Radiation Measurements and Dosimetry Chair: Kishor Mehta Vice-Chairs: Roberto Uribe, Marsh Cleland Update: The latest balloted version of the E10.01 Glossary was distributed to all of the E10.01 Task Group chairs by John Logar following the January meeting in Atlanta. If you would like to receive it, please contact K. Mehta (mehta@aon.at). Please ensure the definitions listed in this glossary are updated in your standard. If changes are needed, please update your standard during the next revision. TABLE 5: SUMMARY OF STATUS OF ASTM E10.01 FOOD IRRADIATION STANDARDS STANDARD NAME TG CHAIR VICE-CHAIRS STATUS E Guide for Irradiation of Pre-packaged Processed Meat and Poultry Products to Control Pathogens and Other Microorganisms F Guide for Irradiation of Fresh Agricultural Produce as a Phytosanitary Treatment F Guide for the Irradiation of Fresh and Frozen Red Meat and Poultry to Control Pathogens and Other Microorganisms F Guide for Packaging Materials for Food to be Irradiated F Guide for Irradiation of Finfish and Aquatic Invertebrates Used as Food to Control Pathogens and Spoilage Microorganisms F Reapproved 2010 Guide for Irradiation of Dried Spices, Herbs, and Vegetable Seasonings to Control Pathogens and Other Microorganisms 9. ISO UPDATES Rod Chu ii jj kk ll mm nn Chris Sommers Ian Winborne Kim Morehouse Kim Morehouse Kim Morehouse Kim Morehouse John Logar John Logar Chris Sommers Open John Logar John Logar Current edition approved June 1, 2005; published July Current edition approved Jan. 1, 2006; published February Current edition approved June 1, 2008; published February Current edition approved Feb. 1, 2009; published March Current edition approved Feb. 1, 2009; published March Last edition approved in Current edition approved Dec. 1, Published January ISO/TC 85 NUCLEAR ENERGY The next meeting of ISO/TC 85 Nuclear energy, nuclear technologies, and radiological protection will be held at AFNOR in Paris June 3-8, AFNOR is the French national standards body. The Working Group meetings of most interest to E10.01 members are WG3 Dosimetry for Radiation Processing and WG1 Terminology, definitions, units and symbols. The WG3 meetings will address the difficulties experienced by E10.01 in having the ISO balloting performed in a timely manner. Standards approved by ASTM cannot be published until they are also approved by ISO.

18 WG1 is preparing a Vocabulary to cover the terms used in standards prepared by ISO/TC 85. Part 2 Radiological Protection has been balloted as a CD and is now being prepared for balloting as a DIS. A New Work Item Proposal (NWIP) has been prepared to begin work on Part 3 Nuclear Fuel Cycle. At the Paris meeting, an NWIP will be presented to begin work on Part 4 Dosimetry for Radiation Processing. General terms used by different groups will be included in Part 1 General, to be prepared after the other parts are completed. ISO/TC 34 WG 10 FOOD IRRADIATION ISO/FDIS 14470, Food irradiation Requirements for the development, validation, and routine control of the `ionizing radiation process used for the treatment of food products. This standard was balloted as an FDIS with the closing date of October 22, The new ISO 14470:2011 was published and is available from ISO PRIOR MEETINGS OF SUBCOMMITTEE E10.01 For those members of Subcommittee E10.01 with a taste for nostalgia, here is the list of previous meeting sites. Jan-84 San Diego, CA Sep-94 Istanbul Jun-04 Boston, Massachusetts Jun-84 Williamsburg, VA Jan-95 Phoenix, Arizona Sep-04 Ste-Adele, Quebec Jan-85 Reno, Nevada Jun-95 Denver, Colorado Jan-05 Atlanta, GA Jun-85 Toronto, Ontario Oct-95 Ste-Adèle, Québec Jun-05 Jackson Hole, Wyoming Jan-86 New Orleans, LA Jan-96 Atlanta, Georgia Feb-06 Phoenix, Arizona Jun-86 Seattle, Washington Jun-96 Hyannis, MA Mar-06 Kuala Lumpur, Malaysia Jan-87 Tampa, Florida Jan-97 New Orleans, LA Jun-06 Ottawa, Canada May-87 Jackson, Wyoming Jun-97 W. Conshohocken, PA Jan-07 Anaheim, California Jan-88 Albuquerque, NM May-97 Anaheim, California Jun-07 Norfolk, VA Jun-88 Andover, MA Jan-98 San Diego, California Jan-08 Tampa, Florida Jan-89 Orlando, Florida Jun-98 Seattle, Washington Jun-08 Denver, CO Apr-89 Noordwijkerhout Nov-98 Vienna Jan-09 Atlanta, GA Jun-89 Gaithersburg, MD Jan-99 San Antonio, Texas Jun-09 Vancouver, BC Canada Oct-89 Ste-Adèle, Québec Mar-99 Melbourne Oct-09 Ettlingen, Germany Jan-90 Las Vegas, Nevada Jun-99 Vancouver Jan-10 San Antonio, TX Jun-90 Pinawa, Manitoba Jan-00 New Orleans, LA Jun-10 St. Louis, MO Nov-90 Vienna, Austria Jun-00 Williamsburg, VA Jan-11 Baltimore, MD Jan-91 San Diego, CA Oct-00 San Diego, CA Jun-11 Montreal, Canada Jun-91 Cape Cod, MA Jan-01 Reno, Nevada Jan - 12 Atlanta, GA Oct-91 College Park, MD Mar-01 Avignon, France Jan-92 Gainesville, FL Jun-01 Norfolk, Virginia Jun-92 Denver, Colorado Jan-02 Dallas, Texas Sep-92 Beijing Jun-02 Tucson, Arizona Jan-93 San Antonio, Texas Jan-03 Albuquerque, NM May-93 Jackson, Wyoming Jun-03 Denver, Colorado Jan-94 San Francisco, CA Sep-03 Chicago, Illinois Jun-94 Sun Valley, Idaho Jan-04 Tampa, Florida 11. FUTURE MEETINGS Dates: Thursday June 28 th Friday June 29 th, 2012 Location: Sheraton San Diego Hotel & Marina, San Diego, CA Event Name: June 2012 Committee Week* *Attendees to this meeting are welcome to join the Workshop Poster Session Social on Wednesday June 27 th and the Workshop Banquet on Thursday June 28 th for a nominal fee.

19 Dates: Sunday January 27 th Wednesday January 30 th, 2013 Location: Hyatt Regency, Jacksonville, FL Event Name: January 2013 Committee Week Dates: Sunday June Wednesday June Location: JW Marriott Indianapolis; Indianapolis, IN US Event Name: June 2013 Committee Week Dates: Sunday January Wednesday January Location: Hyatt Regency Houston; Houston, TX US Event Name: January 2014 Committee Week Dates: Sunday June Wednesday June Location: Snow King Resort, Jackson Hole, WY Event Name: E10/C26 Meeting Alternative Location Dates: Sunday January Wednesday January Location: Sheraton New Orleans, New Orleans, LA US Event Name: January 2015 Committee Week INDUSTRY UPDATES 1. ACTIONS BY AAMI AND ISO/TC 198/WG2 RADIATION STERILIZATION WORKING GROUPS Glenn Calvert, AAMI Liaison with ASTM o o ISO Amendment 1 Amendment 1 - New work item proposal (NWIP) to amend document based on periodic review process. Comments discussed during November 2-3 meeting of ISO/TC 198/WG2. It was noted that several comments were not within scope of the amendment and are being archived for consideration during next revision of ISO o DIS ballot closed August 2011 Approved. o FDIS issued ballot period closes February 15, 2012 ISO o Systematic review postponed pending outcomes of and -3. o o o o o ISO/TS 13004, Sterilization of health care products Radiation Substantiation of a selected sterilization dose: Method VDmax International comments reviewed/discussed during November 2-3 meeting of ISO/TC 198/WG2. Revision of AAMI TIR29:2002, Guide for process control in radiation sterilization Ballot issued December 15, Ballot closed January 26, Results pending. Comments to be assembled and responded. The comments on initial draft were not addressed individually, but rather will be incorporated into the second draft of the document, which the task group is working on and will circulate for comment in advance of the next meeting. Review of current TIRs Sales of current TIR 29 to continue until revision is complete Sales of TIR33 (Substantiation of a sterilization dose Method VDmax) to continue until ISO/TS is complete.

20 o TIR37 (Guidance on sterilization of human tissue-based products) to be revised. J. Hansen to co-chair a task group that will develop draft for review prior to May 2012 WG2 meeting. Upcoming meetings o ISO/TC 198 Paris, April Delegates - L. Foster, T. Bryans, J. Hansen, J. Kowalski. o Liaison reports ASTM o Lisa Foster shared John Logar s presentation re: ASTM activities update as part of ongoing efforts to establish a synergistic relationship with AAMI. Lisa encouraged participation in ASTM. o 7 th ASTM workshop - San Diego (June 2012) o Glenn reported on key ASTM standards development activities and timing of next meeting. Next AAMI Meeting o May 21-23, 2012 If you have any questions or comments on AAMI activities please contact Glenn Calvert at glenn_calvert@bd.com. 2. RADIATION PROCESS SIMULATION AND MODELING USER GROUP (RPSMUG) Josef Mittendorfer, Mike Saylor Mathematical modeling offers tremendous benefits for all owners and user of irradiation facilities. It is emerging as the next frontier to advance the use of radiation processing, which is a well-established technology that globally benefits billions of people, everyday. We welcome new members who are interested or engaged in any facet of radiation processing and modeling. We encourage you to discover how the lower cost of computing power and speed, plus design technology advances have made modeling a practical reality and smart business. If you have any questions regarding RPSMUG, please contact Penny Luxich at (908) We invite everyone to visit the RPSMUG website ( and to consider joining our group. 3. THE COUNCIL ON IONIZING RADIATION MEASUREMENTS AND STANDARDS (CIRMS) Roberto Uribe, Second Vice-President The Council on Ionizing Radiation Measurements and Standards (CIRMS) held its annual meeting on October 17th to the 20th of 2011 at the NIST campus on Gaithersburg MD. The focus of the meeting was on Public Perception of Radiation. The meeting was attended by 110 participants from federal agencies, industry, and academia. The program of the meeting related to ASTM subcommittee E10.01 included plenary talks by Ron Eustice and Anu Prakasch on Public Perception on Irradiated Foods, Walter Voigt on Memory Plastics, and group discussions on Irradiated Foods acceptance by Jeff Barach of the Association of Grocery Manufacturers, Harlan Clemmons from the Sadex Corporation, and FDA regulations by Kim Morehouse regarding the production of furans in irradiated foods. The International Registry of Radiation Safety Officers awarded its 2011 Gunderson Award to Marsh Cleland for his contributions in the field of Radiation Technology. The NEEDs report addressing current needs in radiation measurements and standards was updated following the annual meeting and is now available at the CIRMS website. This year annual meeting will take place on October 22nd to the 25th at the NIST Campus in Gaithersburg MD with a theme on Confidence through

21 Traceability in Radiation Measurements and Standards, with oral and poster presentations. The first announcement and call for papers for the meeting will come out the first week of March. For further information about the meeting interested people is invited to visit and for electronic registration visit 4. INTERNATIONAL IRRADIATION ASSOCIATION (iia) Ruth Brinston, iia Association Manager Update following IMRP Montreal 2011 The Book of Proceedings for the IMRP Montreal 2011 Meeting, published in a special conference issue of the Journal of Radiation Physics and Chemistry, (Elsevier), will be available this Spring. We would like to provide members of ASTM E10.01 the option to buy a hard copy of the Book of Proceedings. If you wish to order a copy, you may do so only until March 20, Cost: $67 CAN per copy. Simply download the Credit Card Authorization Form for the Book of Proceedings, which can be found at this webpage: Return your completed form by fax at by March 20, For additional information on iia, please visit their website at or contact Ruth Brinston at rbrinston@iiaglobal.org. 5. THE PANEL ON GAMMA and ELECTRON BEAM IRRADIATION Cathie Deeley, Chairman For additional information, please visit or contact Cathie Deeley at cathie.deeley@reviss.co.uk for more information regarding The Panel activities. 6. COURSES AND WORKSHOPS CANADIAN IRRADIATION CENTRE (CIC): CIC is a training centre operated as a joint venture by MDS Nordion and the Université du Québec, Institut Armand-Frappier (IAF). The CIC's objectives are to develop, demonstrate and promote radiation processing and its diverse applications by: conducting applied research; training technical, professional and scientific personnel; educating industry and government; demonstrating operational and scientific procedures; developing processing procedures and standards; performing product and market acceptance trials. Courses include: Radiation Safety in Industrial Irradiator Operations, Industrial Irradiator Operator Course, Radiation Safety Officer (Industrial Irradiator), Advanced Industrial Irradiation Dosimetry, Irradiation Facility Management Course, Irradiator Technology for Inspectors, Radiation Safety Officer (Research Irradiator), Radiation Safety Review for Operators, Basic Industrial Irradiation Dosimetry and Food Irradiation Seminars. To obtain the current course calendar and more information on the courses at CIC, visit GEX CORPORATION: The GEX three-day GEX Dosimetry Workshops combine lectures and hands-on training to provide complete training in all aspects of dosimetry. The Workshops reflect the latest industry practices, including the newly revised ISO Radiation Sterilization standard and other newly published or revised dosimetry

22 standards. Participants acquire the necessary knowledge and tools to successfully establish, manage, and optimize an industrial radiation dosimetry program. Participants can achieve a superior working knowledge of current industry methods and practices and learn how to apply and use dosimetry guides and practices. Participants are given a compendium notebook containing related technical articles and application protocol documents. They also receive a formal certificate for successful completion of the Workshop. The courses are intended for radiation equipment providers, application specialists, technicians, quality control, management and regulatory personnel. Smaller groups are used to cover application specific dosimetry situations. The workshops address all aspects of an industrial dose measurement program with hands-on training exercises and covers topics on how to: Define dosimetry lab requirements Specify and select equipment and dosimeters Install and maintain dose measurement equipment Develop and implement required protocols Calibrate routine dosimeter batches Maintain batch calibrations Measure dosimeters and determine dose Dose map the irradiator facility Dose map products Prepare reports and analyze the dose measurement results Use, manage and archive dose measurement data Please visit for workshop updates. In addition you can contact Mike Pageau via at mpageau@gexcorp.com. KENT STATE UNIVERSITY A Design of Experiments course under the Master of Technology (MT) degree in the College of Technology has been offered during the last two semesters as a Special Topics class. Given the interest of students in the graduate program for this subject, the course will be proposed as a regular course within the MT. The course covers material related to some standards developed by subcommittee E10.01, including, basic statistical models, introduction to ANOVA, dealing with nuisance factors, design of experiments including factorial designs, and fractional factorial designs. Some projects related to Radiation Processing have been suggested to the students as part of the requirements for this course. People interested in more information about these courses please contact Dr. Roberto Uribe at ruribe@kent.edu. RISO COURSES Validation and Process Control for Electron Beam Sterilization May & September 3-7, 2012 This Risø course provides background for understanding the requirements of the radiation sterilization standard EN ISO with focus on the dosimetric aspects of electron beam sterilization as required in - IQ/OQ, Installation / Operational Qualification - PQ, Performance Qualification - Routine monitoring and Process Control. The emphasis of this course is on electron beam sterilization, but users of gamma sterilization will also benefit from participating. We collaborate with Sterigenics, Denmark. Participants will - calibrate dosimeters to be used in the subsequent exercises, - carry out IQ/OQ measurements on the 10 MeV electron accelerator, - perform PQ dose mapping on products that are to be electron sterilized, - make routine dosimetric process control. Methods for selecting or substantiating a sterilization dose for medical devices are described in EN ISO 11137, part 2. These methods are covered by lectures and exercises based on simulated data. Additional lectures cover effects of radiation on polymers and biocompatibility. Validation and Process Control for Low Energy Electron Beam Irradiation - March 19-21, 2012

23 This course is designed for users of kev electron beam sterilization or decontamination. The special aspects of dosimeter calibration and dose measurements at this energy level are addressed through practical exercises using the Risø 100 kev electron accelerator. Find more information and registration at - click on Courses 7. UPCOMING EVENTS in the RADIATION PROCESSING INDUSTRY From the iia newsletter 2012 Annual Hands-on Workshop in E-Beam and X-Ray Irradiation Technologies, National Center for Electron Beam Research, TAMU, College Station, Texas, USA 1-6 April 2012 MD&M East, Pennsylvania Convention Center, Philadelphia, PA, USA May 2012 ASTM 7th International Workshop on Dosimetry for Radiation Processing, Sheraton San Diego Hotel & Marina, San Diego, CA, USA June 2012 MD&M Brazil, San Paulo, BRAZIL June 2012 Medical Fair, Suntec, Singapore, September 2012 IAEA General Conference, 56th Session, Vienna, AUSTRIA September 2012 IRaP 2012, International Symposium on Ionizing Radiation and Polymers, Cracow, POLAND October BOOKS and JOURNALS OF INTEREST IN RADIATION PROCESSING 1. To obtain a printed copy of ICRU Report 80, Dosimetry Systems for Use in Radiation Processing, you need to purchase an individual subscription for the Journal of the ICRU for the year 2008 for $200 (US dollars). This subscription will give the purchaser both reports published in ICRU 80 and ICRU 79, Receiver Operating Characteristic Analysis in Medical Imaging. Back issues up to ICRU 79 can be purchased as individual reports for $192. ICRU 80 cannot yet be purchased as a back issue, but there will only an $8 cost saving when it is available as a back issue. The form for ordering the report can be obtained from the website 2. The book, Radiation Sterilization for Health Care Products: X-Ray, Gamma, and Electron Beam by Barry Fairand, is available from CRC Press at This book addresses the critical elements of the technology including chapters on basic principles, dosimetry, effects of radiation, irradiators, process validation, processing with irradiators and commercial aspects. 3. The IAEA has completed a publication on food irradiation dosimetry (Dosimetry for Food Irradiation, IAEA, Vienna, 2002, Technical Report Series no.409). It is available without cost at This book is the 2nd edition of K.H. Chadwick, D.A.E. Ehlermann and W.L.McLaughlin, Manual of Food Irradiation Dosimetry, International Atomic Energy Agency, Vienna, 1977, Techn. Reports Series no.178, which is referenced in many ASTM-standards on food irradiation and on dosimetry. It had been out of stock for years, and the 2nd edition is a complete up-date. The new edition had been drafted by I. de Bruyn, R. Chu, D.A.E. Ehlermann, W.L. McLaughlin, K.Mehta, P. Thomas; D.A.E. Ehlermann incorporated materials from other contributors and from IAEA staff members, and finally K. Mehta revised and edited the document for printing as IAEA Technical Report. The 1977 edition which was the first of its kind had not become obsolete in its contents; however, during those 25 years substantial material had been published in separate textbooks and in ASTM standards, and hence, detailed description of a range of dosimetry systems could be omitted. Instead the focus is on irradiator design concepts, process validation, facility operation, process control and the contribution of dosimetry and dosimetry systems.

24 4. The book, Food Irradiation Research and Technology is published by Blackwell Publishing and currently available. It is edited by Christopher H. Sommers (United States Department of Agriculture Agricultural Research Service) and Xuetong Fan (United States Department of Agriculture - Agricultural Research Service). This book is now undergoing its first revision. The targeted publishing date for the first revision is The benefits of food irradiation to the public health have been described extensively by organizations such as the Centers for Disease Control and Prevention in the U.S. and the World Health Organization. The American Medical Association and the American Dietetic Association have both endorsed the irradiation process. Yet the potential health benefits of irradiation are unknown to many consumers and food industry representatives who are wary of irradiated foods due to myth-information from "consumer-advocate" groups. ASTM colleagues Marsh Cleland, Kishor Mehta, C. Sommers, J. Maxim, Robert Griffin and Kevin O Hara have helped with the book. Visit for more information. 5. The IAEA has a publication on gamma irradiators (Gamma Irradiators for Radiation Processing, IAEA booklet, 40 p July 2005) available free from: Head, Industrial Applications and Chemistry Section, International Atomic Energy Agency, Wagramer Strasse 5, Vienna A-1400, Austria; Website address: The radiation technology is one of the most important fields which the IAEA supports and promotes, and has several programmes that facilitate its use in the developing Member States. In view of this mandate, this Booklet on Gamma Irradiators for Radiation Processing is prepared which describes variety of gamma irradiators that can be used for radiation processing applications. It is intended to present description of general principles of design and operation of the gamma irradiators available currently for industrial use. It aims at providing information to industrial end users to familiarise them with the technology with the hope that the information contained here would assist them in selecting the most optimum irradiator for their needs. Correct selection affects not only the ease of operation but also higher efficiency and thus improved economy. It is also intended for promoting radiation processing in general to governments and general public. The Booklet is prepared by the IAEA s Industrial Applications and Chemistry Section, Division of Physical and Chemical Sciences with the assistance provided by consultant Mr. Kishor Mehta. The IAEA staff member responsible for this project was Mr. A. Chmielewski. The IAEA is grateful to all persons and organizations that provided valuable information for the Booklet. 6. GEX Corporation has recently published second edition of Kishor Mehta s Radiation Processing Dosimetry: a practical manual. The book retails for $40.00 USD each, with a $10.00 discount or $30.00 sales price offered to all ASTM E10.01 members. Contact GEX at or mpageau@gexcorp.com to place your order. Major credit cards will be accepted for payment. A $5.00 shipping and handling fee will be added. 7. A new book Trends in Radiation Sterilization of Health Care Products from the IAEA was published in 2008 and can be down-loaded at iaea.org/mtcd/publications/pdf/pub1313_web.pdf 8. In August of 2010, the IAEA released an IAEA Safety standard, titled: Radiation Safety of Gamma, Electron and X Ray Irradiation Facilities (Specific Safety Guide No. SSG-8). The paper copy costs EURO 30. However, it is freely available at : FINAL NOTE

25 It is my hope that the Progress Report remains useful, and detailed. Please contact me if you have comments or concerns. John R. Logar, Chairman E10.01

26 APPENDIX A Action Item List from Atlanta E10.01 Meeting January 29 th February 1 st, Standards Action. Open Work Items based on year TG Chairs ongoing ongoing 2 Members to update contact information on ASTM site All ongoing ongoing 3 Members to update TG Matrix. Notify J Rickey. J Rickey All/ JRickey ongoing ongoing to send out to All TG Chairs. 4 Workshop Related: Need our new Process Control Standard developed before the workshop. MB/JAW/DP Jun March 1, Workshop Related: Sponsorship: If you want information All Jun about requesting sponsorship, let JLogar know 6 June 2012 E10.01 Meeting: Reminder that E10.01 meeting Logar Jan 2012 Apr 2012 on Thurs/Friday of Workshop. JLogar to send updates to members about registering to join us on Thursday night to the banquet for networking with workshop attendees. 7 Early E10.01 group photos have been digitally restored. Logar/ Update Feb Still open ACTION: John will forward the file to Marc D who will Desrosiers/ 1, 2012 put outline of the image and add names. JLogar to send files Rickey Jun to any interested member. John Rickey to set up a webpage for downloading. 8 Development of Test Method. 15 members indicating interest in the development of Test method Task Group, led by Gary Pageau and Brad Lundahl. ACTION: JLogar to send solicitation to members to identify any others interested in this new TG. Still open. Brad working on TM for reproducibility Logar/ G Pageau/ B Lundahl Update Feb 1, 2012 Jun June Send Ballot Form to everybody. Reminder to use when Logar/ Koury Update Feb ongoing balloting. 1, John will follow-up with Eric Baucrain(?) for ISO ballots Logar Jun Ongoing! 11 If anyone interested in presenting on behalf of ASTM at All ongoing Ongoing E10.01 sponsored events contact J Logar 12 1 st Subcommittee ballot Deadline Feb 13, Send to Rod before. (Subcommittee ballots can be sent at other times in addition to these dates) All chairs Jan 29, 2012 Feb 13, Concurrent/Main Committee ballot Deadline Mar 21, All chairs Jan 29, 2012 Mar 21, 2012 Send to Rod min 1 week before. 14 2nd Subcommittee Apr 16, 2012 Main ballot Deadline May 10, Send to Rod before All chairs Jan 29, 2012 Apr 19, 2012 May 10, ISO DIS ballot items submitted as soon as possible to Rod. All chairs ongoing ongoing (timeline is 5 months) 16 Input from all for PR72 to J Logar by Feb 25, 2012 TG chairs /All Jan 29, 2012 Feb 25, Workshop related: All slides finalized by Mar 1 st. Plenary, Hands-on maybe 2 weeks extra. Anything that we plan to hand out needs to be in to ASTM to Print on time. Workshop Chairs Jan 29, 2012 Mar 1, Subcommitte to New Committee: ballot J Logar Jan 30, Radiation Indicator labels. TG to review and revise for ballot. John to get Mike copy of standard and talk to Mark Murphy MPageau/ JLogar Feb 1, 2012 June ISO standard designation Contract between ASTM & ISO needs to be reviewed 21 June Meeting Information: John Logar to send details of meeting for E10.01 and opportunity to join socials with Workshop attendees. Also will invite workshop attendees to the Friday meeting for E Updated Glossary from Kishor will be sent to John Logar to distribute to TGC J Koury Feb 1, 2012 March 1, 2012 J Logar Feb 1, 2012 May 2012 K Mehta/ JLogar Feb 1, 2012 Ongoing

27 Appendix B NEW PROPOSED COMMITTEE STRUCTURE Return to Outline

28 Appendix B (Cont.) NEW PROPOSED COMMITTEE STRUCTURE (Cont.) Return to Outline